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Merk announces antiviral Molnupiravir.....this is important


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3 minutes ago, Amati said:

Take the vaccinations, and use all the other stuff (including masks :ph34r:) to inch % towards 100.  Easy easy.

From Israel.  The index case was fully vaccinated.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.39.2100822

We have investigated a nosocomial COVID-19 outbreak involving the SARS-CoV-2 Delta variant among a highly vaccinated population. The attack rate among exposed individuals reached 23.3% in patients and 10.3% in staff, with 96.2% vaccination rate among exposed individuals. Moreover, several transmissions probably occurred between two individuals both wearing surgical masks, and in one instance using full PPE, including N-95 mask, face shield, gown and gloves.

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https://pubchem.ncbi.nlm.nih.gov/compound/ivermectin   Description Ivermectin is an orally bioavailable macrocyclic lactone derived from Streptom

Nope.  Chuckle. Unlike the drug you are referring to, this is a genuine anti-viral not an anti-parasitic.  The trial size was compact but the results in a genuine blind placebo trial were statisticall

It’s patent expired in 1996  its a generic drug available globally for 1 $  

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39 minutes ago, Kate short for Bob said:

From Israel.  The index case was fully vaccinated.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.39.2100822

We have investigated a nosocomial COVID-19 outbreak involving the SARS-CoV-2 Delta variant among a highly vaccinated population. The attack rate among exposed individuals reached 23.3% in patients and 10.3% in staff, with 96.2% vaccination rate among exposed individuals. Moreover, several transmissions probably occurred between two individuals both wearing surgical masks, and in one instance using full PPE, including N-95 mask, face shield, gown and gloves.

You might want to read the whole article.

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18 minutes ago, NeedAClew said:

Stop calling me "elder" dammit.

:)  Elder! :lol:

(I may be close to the big 7-0, but my brain still thinks I’m 35!)

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5 hours ago, Raz'r said:

yeah, no, you can't play politics or amateur psychologist. The public med authorities need to make sure they have the meds on hand to treat people. 

You haven't been here to experience the" go stop go" confusion with AZ and Pfizer supplies.

The idiots are going to continue being idiots if they think they can just take a pill. 

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2 minutes ago, Kate short for Bob said:

You haven't heard of oral vaccines?

Relevant to the discussion? how? this new pill is not a vaccine.

Fuck off sock.

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1 minute ago, Kate short for Bob said:

But it supposedly achieves the same outcome given the main vaccine of choice doesn't eliminate transmission.

Kiwi mikey is also a liar

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21 minutes ago, Kate short for Bob said:

But it supposedly achieves the same outcome given the main vaccine of choice doesn't eliminate transmission.

Oh Dear

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Molnupiravir

46 minutes ago, Kate short for Bob said:

it supposedly achieves the same outcome

Molnupiravir and any other antiviral perform a very role than vaccines for a number of reasons. The most notable is that a vaccine is intended to prevent you getting a disease. The antiviral is a treatment for someone who has already contracted the disease.. Trying to use Molnupiravir as a prophylactic will have a very different outcome than getting vaccinated.  Trying to vaccinate someone as a treatment after they have contracted the disease will not result in a good outcome.

anyway....enjoy your day...Im getting some sleep.

On vaccination for under 12s....we do not disagree at this time.

On the option of other antvirals for covid. I want to challenge you on that again. It will have to wait for tomorrow, but in the meantime I will ask you for the THIRD time to name some on the list of alternative antivirals you keep referring to

 

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the bit that interests me is

is Molnupiravir a ' broad spectrum' anti viral

it could be a real boon for a lot of things .. cutting the long term cost of the Anally Injected Death Sentence for one

obvious why they have concentrated on C19 but have they released the lab tests on other stuff yet

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On 10/1/2021 at 5:30 PM, Kate short for Bob said:

You'd have to question @EYESAILOR's motivation for starting this thread on one specific trial drug when there are other antivirals equally worthy. 

I replied.    Kate goes on to refer to alternative anti virals for covid two more times. Each time I ask for this list of the other anti virals that have been proven effective and safe vs covid.  

He never replies.  KSB.......I do not believe there is an alternative except for Remdesivir.  Please enlighten us.

 

On 10/2/2021 at 11:54 AM, EYESAILOR said:

2. What are the antivirals that are equally worthy to Molnupravir in the treatment of covid ? 

You cannot be referring to Remdesivir. 

16 hours ago, Kate short for Bob said:

I note that you don't refer to other anti-viral drugs that already have approval and a proven safety and efficacy record.                                                     

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7 hours ago, Kate short for Bob said:

So where have I lied?

Woops my name isn't Mikey.

You can accuse me of any number of things but I'm not a liar.  

You're a sock puppet. A deceiver. 

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21 minutes ago, EYESAILOR said:

replied.    Kate goes on to refer to alternative anti virals for covid two more times. Each time I ask for this list of the other anti virals that have been proven effective and safe vs covid.  

He never replies.  KSB.......I do not believe there is an alternative except for Remdesivir.  Please enlighten us.

FFS @EYESAILOR we live in completely different times zones and it is hard enough wading through the extraneous dross that gets posted let alone replying to your every request.

Are you saying as a Medical Professional you are not away of ANY other antivirals that have been part of Covid-19 treatment protocols?

Woops there you go you name one - Remdesivir.  

BTW Merck didn't develop Molnupiravir - they bought it off someone else not that that is an important distinction.

I assume you use a narrow definition of antivirals?

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17 hours ago, Kate short for Bob said:

I note that you don't refer to other anti-viral drugs that already have approval and a proven safety and efficacy record.

 

 

On 10/2/2021 at 7:30 AM, Kate short for Bob said:

You'd have to question @EYESAILOR's motivation for starting this thread on one specific trial drug when there are other antivirals equally worthy. 

Your statements Mikey, you back em up

21 minutes ago, EYESAILOR said:

I replied.    Kate goes on to refer to alternative anti virals for covid two more times. Each time I ask for this list of the other anti virals that have been proven effective and safe vs covid.  

He never replies.  KSB.......I do not believe there is an alternative except for Remdesivir.  Please enlighten us.

 

You're learning. He wont.

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https://www.abc.net.au/news/science/2021-09-12/covid-19-cure-drug-antiviral-hiv-treatment-remdesivir/100444818

Interesting reading for us non sciency people.

Why viral infections are so hard to cure, and how antivirals like COVID-19 drug remdesivir work

snip

But remdesivir, the only direct-acting antiviral approved for use in COVID-19 in Australia, isn't spectacular, says Sharon Lewin, an infectious disease researcher and director of the Doherty Institute.

"It gives you a little bit of time, it reduces your time in hospital and may potentially have a small mortality benefit, but it's not dramatic."

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11 minutes ago, ShortForBob said:

 

Your statements Mikey, you back em up

You're learning. He wont.

 

1 minute ago, Kate short for Bob said:

@EYESAILOR has already given one Remdesivir.  Yes she will argue that it isn't a pill and has to be given intravenously.

Back to your library Meli.  Are you on late night stacking duty?

Hahaha.

But remdesivir, the only direct-acting antiviral approved for use in COVID-19 in Australia, isn't spectacular, says Sharon Lewin, an infectious disease researcher and director of the Doherty Institute.

"It gives you a little bit of time, it reduces your time in hospital and may potentially have a small mortality benefit, but it's not dramatic."

we are waiting for you to back you're statements about other antivirals . Plural.

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12 minutes ago, ShortForBob said:

Hahaha.

But remdesivir, the only direct-acting antiviral approved for use in COVID-19 in Australia, isn't spectacular, says Sharon Lewin, an infectious disease researcher and director of the Doherty Institute.

"It gives you a little bit of time, it reduces your time in hospital and may potentially have a small mortality benefit, but it's not dramatic."

So you are knocking Remdesivir now? 

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On 10/2/2021 at 1:23 AM, EYESAILOR said:

Merk announced early this morning that it has a successful antiviral pill for Covid

For the record it wasn't I who took this Topic down the Ivermectin wormhole.

I questioned the motivation behind @EYESAILOR's pronouncement that Merck "has a successful antiviral pill".

I then questioned how that can be declared on the basis of results from a comparatively small and limited trial of 775 people half of whom had received the pill.

It is inevitable that the FDA will give EUA to it.  Personally I don't like the path the FDA now seems intent on going down with lower standards of releasing drugs to the general population.  But others have different standards.  It isn't as if the FDA have had to back track on such approvals in the past.

 

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39 minutes ago, Kate short for Bob said:

FFS @EYESAILOR we live in completely different times zones and it is hard enough wading through the extraneous dross that gets posted let alone replying to your every request.

Are you saying as a Medical Professional you are not away of ANY other antivirals that have been part of Covid-19 treatment protocols?

Woops there you go you name one - Remdesivir.  

BTW Merck didn't develop Molnupiravir - they bought it off someone else not that that is an important distinction.

I assume you use a narrow definition of antivirals?

You keep on posting that there are other worthy antivirals equal to or superior to Mvir. I keep asking. It seems unlikely that you would miss the questions. Why participate in the discussion, if you make unsupported and inaccurate statements and do not respond when challenged on the core topic of discussion? Instead you twitter on about putting antivirals in the water supply and other nonsensical and sarcastic comments.

Again, what are these anti-virals that you consider to be "worthy" alternatives?  Really ?

In my post in response to your comment, I outlined the important advantages and differences Mvir brings to the battle against Covid compared to Remdesivir.  If you disagree, I'd like to hear why!

By the way, if Remdesivir's trial was large enough in your eyes to provide a "proven safety and efficacy record" (quoting you), why do you have a problem with Mvir's trial? 

I happen to think both will have their place in the treatment of covid. But I think Mvir will be more important in mainstream high risk cases.

 

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7 minutes ago, Kate short for Bob said:

I then questioned how that can be declared on the basis of results from a comparatively small and limited trial of 775 people half of whom had received the pill.

It is inevitable that the FDA will give EUA to it.  Personally I don't like the path the FDA now seems intent on going down with lower standards of releasing drugs to the general population.  But others have different standards.  It isn't as if the FDA have had to back track on such approvals in the past.

 

1. The results on that trial size were statistically significant.  You have to realize that all the patients in the trial had already contracted covid and were high risk patients. The primary group did substantially better than the primary group, by a truly significant margin. 

2. The enrollment was stopped at over 1,000 so the data will increase......but an independent oversight committee of scientists determined that the results were so significant that enrollment should cease. The FDA agreed (so yes, it is highly likely that it will gain EUA).   

3. These are not lower standards and it will be a limited EUA not approval.

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7 minutes ago, EYESAILOR said:

By the way, if Remdesivir's trial was large enough in your eyes to provide a "proven safety and efficacy record" (quoting you), why do you have a problem with Mvir's trial? 

How long has Remdesivir had approval as an antiviral?

I've told you why I have a problem with Merck's trial on more than one occasion.

As well I have an issue with the headline "Merck announces highly successful antiviral pill" and the fact that it seems to be on a predetermined path to EUA.

Given the stage of the pandemic if I was Merck I would be testing it for its efficacy on other respiratory viral infections.

 

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4 minutes ago, EYESAILOR said:

1. The results on that trial size were statistically significant.  You have to realize that all the patients in the trial had already contracted covid and were high risk patients. The primary group did substantially better than the primary group, by a truly significant margin. 

2. The enrollment was stopped at over 1,000 so the data will increase......but an independent oversight committee of scientists determined that the results were so significant that enrollment should cease. The FDA agreed (so yes, it is highly likely that it will gain EUA).   

3. These are not lower standards and it will be a limited EUA not approval.

Give us a break @EYESAILOR does limited EUA actually mean anything curently? 

The vaccines had EUA but we didn't see much limited use!

Does Aduhelm ring any alarms for you?

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1 minute ago, Kate short for Bob said:

How long has Remdesivir had approval as an antiviral?

I've told you why I have a problem with Merck's trial on more than one occasion.

As well I have an issue with the headline "Merck announces highly successful antiviral pill" and the fact that it seems to be on a predetermined path to EUA.

Given the stage of the pandemic if I was Merck I would be testing it for its efficacy on other respiratory viral infections.

 

Remdesivir was approved for treatment of covid on October 22nd 2020.

What are your problems with Merks trial? Other than size and significance, where you are stating an unscientific opinion that disagrees with an independent oversight committee.

What are the other anti-virals that you consider equal to or superior to Mvir in the treatment of covid?

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On 10/1/2021 at 5:30 PM, Kate short for Bob said:

You'd have to question @EYESAILOR's motivation for starting this thread on one specific trial drug when there are other antivirals equally worthy. 

Umm KSB.......this is your exact quote.  You made no mention of trial size.  You questioned my motive on the basis of "other antivirals equally worthy"

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6 minutes ago, Kate short for Bob said:

No I questioned your motivation in the first instance on your pronouncement of high success based on a small limited trial.

So this would be an inadvertent misstatement. What are the other equally worthy antivirals that caused you to question my motive for starting the thread......and FWIW, I did not use the words "highly successful " or "high success". I am not prone to superlatives.

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6 minutes ago, EYESAILOR said:

Im hearing crickets.

You answered your own question with Remdesivir.

Don't you think it is weird that it is harder to repurpose approval for a broad spectrum antiviral that has been in active use for number of years than it is for Merck's new kid on the block?

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3 minutes ago, Kate short for Bob said:

You answered your own question with Remdesivir.

Don't you think it is weird that it is harder to repurpose approval for a broad spectrum antiviral that has been in active use for number of years than it is for Merck's new kid on the block?

Any others at all?   I only ask since I compared Mvir to Rvir in my early post asking you to support your claim.

Do you think Rvir is superior or equal to Mvir for the treatment of covid?   Have you  taken a glance at the Solidarity trial conducted on Rvir supervised by the WHO?

Have you looked at the two trials on Rvir that were conducted in the US and the November update?

I think that Rvir has its place in the armory but I challenge you to question my motives after you have done a little work on comparing the 2 antivirals.

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I don't think something you have to be sick enough to be hospitalized to get and get intravenously at that is "superior" to a pill you take to keep from getting hospitalizably sick. 

Rimbeever will be useful for a smaller percentage of infected. 

What a crock you are Ksfb. 

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I want to quickly apologize for all this bickering to and forth. It comes across as small minded.

The big picture is that IMHO, this is the most important anti viral progress we have seen vs Covid thus far.  Even,if you think Remdisivir is very effective vs hospitalized covid patients (Rvir is only approved for hospitalized patients) , it clearly adds to the treatment protocol for covid patients.

Given the significant level of reducing the risk of hospitalization for high risk infected patients (50%) and reducing risk of death for high risk patients, and the decision of the independent oversight committee (it is a big deal to stop enrolling a trial early) and the consultation the IOC had with the FDA, ....I think it is highly likely Merck applies for and receives an EUA.

The researchers and the IOC will continue to monitor the existing candidates from the trial for any safety issues and monitor patients who subsequently are treated with Mvir but at the very least, this will get an EUA for high risk patients.....and so it should do.  

I hope (and Im sure everyone else joins me in this) that the drug continues to prove successful and that no dangerous adverse effects occur. Then it might be considered for a wider population.

 

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2 hours ago, Kate short for Bob said:

I then questioned how that can be declared on the basis of results from a comparatively small and limited trial of 775 people half of whom had received the pill.

It is inevitable that the FDA will give EUA to it.  Personally I don't like the path the FDA now seems intent on going down with lower standards of releasing drugs to the general population. 

 

I dont mean to beat a dead horse.......but the trial size of 775 high risk patients who have already contracted Covid does not represent a lower standard.

I should point out that the phase 3 trials of Tamiflu in 1999 consisted of 849 patients, and they were a broad range of patients from 18 -65.  Tamiflu had a 30% improvement in time to recovery.  Mvir has been tested in high risk patients and reduced hospitalization by 50%! with no reported deaths during the trial thus far.

FWIW, I personally am not a big fan of Tamiflu but that is not a professional opinion. I think that Xofluza might be a better treatment in the long term, but lets not go down that rabbit hole. Its a whole new subject. Xofluza phase 3 trial was 1,436 broad spectrum patients between 12-64 with no bias towards high risk patients.

Again , Merck's phase 3 trial was enrolling a larger number than each of these well regarded trials and only stopped enrollment because of the results thus far in a high risk population.

So again, whether I think the results are significant (I do) is irrelevant, the Independent Oversight Committee and the FDA think they are significant .  I suspect they have more information and more expertise than either @Kate short for Bob or myself.....well certainly more than me. 

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33 minutes ago, Rain Man said:

If only KSFB applied the same high standard of proof to his/her/their own beliefs as he/she/they does to everyone else's.  @EYESAILOR you are some kind of saint with your patience.

Patience running out on the matter of this antiviral

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3 hours ago, Kate short for Bob said:

You answered your own question with Remdesivir.

Don't you think it is weird that it is harder to repurpose approval for a broad spectrum antiviral that has been in active use for number of years than it is for Merck's new kid on the block?

Kate,

It is not harder to gain approval for repurposing an existing approved drug than gaining approval for new drugs. It is generally less demanding to get repurpose approval to add to the label. You rush off these inaccurate statements without much thought and then complain when you get a reputation for lack of veracity.

As to Remdesivir as your example of a antiviral that is worthy alternative to Mvir.  Mvir has reduced hospitalization in high risk patients by 50%. How much does Rvir reduce hospitalization of covid patients by?

 

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4 minutes ago, EYESAILOR said:

Kate,

It is not harder to gain approval for repurposing an existing approved drug than gaining approval for new drugs. It is generally less demanding to get repurpose approval to add to the label. You rush off these inaccurate statements without much thought and then complain when you get a reputation for lack of veracity.

As to Remdesivir as your example of a antiviral that is worthy alternative to Mvir.  Mvir has reduced hospitalization in high risk patients by 50%. How much does Rvir reduce hospitalization of covid patients by?

 

It's amazing how a supposed Kiwi knows so much about the US drug approval regime...

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15 minutes ago, Raz'r said:

It's amazing how a supposed Kiwi knows so much about the US drug approval regime...

Even more amazing that she "cares" about what the FDA does in the USA, WTF. Hide in your troll house, Kate.

Eye, you are a saint, but you are slowly discovering that Kate is just a troll, baiting you and others endlessly with her drivel of seemingly relevant questions.

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1 hour ago, Raz'r said:

It's amazing how a supposed Kiwi knows so much about the US drug approval regime...

Well you don't appear to know anything about it. 

The reason that a Kiwi has an interest in the FDA process is because our approval authority Medsafe seems to blindly follow the FDA.  Also it is easier to source the data from the FDA than our own approval authority.

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2 hours ago, EYESAILOR said:

horse.......but the trial size of 775 high risk patients who have already contracted Covid does not represent a lower standard.

FFS @EYESAILOR stop obfuscating the fact that ONLY 380 people received the actual drug!  If you believe that that population sample size is sufficient then go for it.  I don't consider it sufficient. 

2 hours ago, EYESAILOR said:

I should point out that the phase 3 trials of Tamiflu in 1999 consisted of 849 patients, and they were a broad range of patients from 18 -65.  Tamiflu had a 30% improvement in time to recovery.  Mvir has been tested in high risk patients and reduced hospitalization by 50%!

Yes and we know where Tamiflu ended up don't we?  Billions spent and wasted and a litany of lies from Roche regarding hidden data.

2 hours ago, EYESAILOR said:

So again, whether I think the results are significant (I do) is irrelevant, the Independent Oversight Committee and the FDA think they are significant .  I suspect they have more information and more expertise than either @Kate short for Bob or myself.....well certainly more than me. 

If they do have more information and data then it will be great to see it published.  Afterall the FDA has an unblemished record approving drugs - doesn't it?

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1 hour ago, EYESAILOR said:

It is not harder to gain approval for repurposing an existing approved drug than gaining approval for new drugs.

Seems to have been harder Remdesivir.  I'm surprised you haven't pointed out that WHO didn't approve it but the FDA has.  I guess they had different trial data?

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3 hours ago, EYESAILOR said:

Given the significant level of reducing the risk of hospitalization for high risk infected patients (50%) and reducing risk of death for high risk patients

So what would you say if I posted a paper that shows an existing drug (which doesn't have repurpose approval from the FDA) used in a larger trial than Merck showed a 67% reduction in hospitalisations?

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Molnupiravi

2 hours ago, Kate short for Bob said:

FFS @EYESAILOR stop obfuscating the fact that ONLY 380 people received the actual drug!  If you believe that that population sample size is sufficient then go for it.  I don't consider it sufficient. 

 

Why not?   What mathematical, statistical or scientific basis do you have for considering that sample size is insufficient ?

You are toxic in your inaccuracies so let us at least get the data correct. As at the time of the interim report, 695 patients had been administered with the appropriate dosage of Molnupiravir and 695 had received the placebo. Of those, 385 patients who had received Mvir were 29 days or more subsequent to randomization and 377 were 29 days or more since the placebo for a 29+ database of 762 patients (13 patients were withdrawn from the trial).

From that data set, the ratio of patients from the control group (received the placebo) had double the number of patients hospitalized compared to the primary group (received the antiviral) .  The control group experienced 8 deaths, the primary group experienced 0 deaths. The hospitalization data is equivalent to a p-value of 0.0012, which is "highly significant".     This was a well run rigorous trial with a highly significant result.  

I contrast that with your anecdotal data about the long term effects of flu.

 
 

 

 

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17 minutes ago, EYESAILOR said:

Molnupiravi

Why not?   What mathematical, statistical or scientific basis do you have for considering that sample size is insufficient ?

You are toxic in your inaccuracies so let us at least get the data correct. As at the time of the interim report, 695 patients had been administered with the appropriate dosage of Molnupiravir and 695 had received the placebo. Of those, 385 patients who had received Mvir were 29 days or more subsequent to randomization and 377 were 29 days or more since the placebo for a 29+ database of 762 patients (13 patients were withdrawn from the trial).

From that data set, the ratio of patients from the control group (received the placebo) had double the number of patients hospitalized compared to the primary group (received the antiviral) .  The control group experienced 8 deaths, the primary group experienced 0 deaths. The hospitalization data is equivalent to a p-value of 0.0012, which is "highly significant".     This was a well run rigorous trial with a highly significant result.  

I contrast that with your anecdotal data about the long term effects of flu.

 
 

 

 

Well, here's the thing. Humans don't seem to be able to comprehend statistics very well (hence the popularity of the lottery) and Kiwi Mikey, for all his faults, is likely just another one.

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38 minutes ago, EYESAILOR said:

You are toxic in your inaccuracies so let us at least get the data correct. As at the time of the interim report, 695 patients had been administered with the appropriate dosage of Molnupiravir and 695 had received the placebo. Of those, 385 patients who had received Mvir were 29 days or more subsequent to randomization and 377 were 29 days or more since the placebo for a 29+ database of 762 patients (13 patients were withdrawn from the trial).

 

Where do you get the 695 + 695 from?  It wasn't mentioned in either of the first two links you posted.  As for the being toxic - I quoted directly from your links.  My opinion is the trial is too small - you have a different opinion.  If you have other data then fine but your headline and the links you reported were based on the following number of trial participants.  The second link stated this:

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012.

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21 minutes ago, Kate short for Bob said:

Where do you get the 695 + 695 from?  It wasn't mentioned in either of the first two links you posted.  As for the being toxic - I quoted directly from your links.  My opinion is the trial is too small - you have a different opinion.  If you have other data then fine but your headline and the links you reported were based on the following number of trial participants.  The second link stated this:

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012.

If you understood statistics the way you state you do, you'd understand that's a damn strong indication that the drug worked. Now, would we like a more significant population? Sure, if it didn't mean people wouldn't die to test it. Medical ethics being what they are, this is strong enough to end the test and look to help the folks getting the placebo. I'm sure you don't mean you want people to needlessly die so you feel "confident"

.10 < P < 1.0 Þ insignificant evidence against H0

.05 < P ≤ .10 Þ marginally significant evidence vs. H0

.01 < P ≤ .05 Þ significant evidence against H0

   0 < P ≤ .01 Þ highly significant evidence against H0

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19 minutes ago, Raz&#x27;r said:

If you understood statistics the way you state you do, you'd understand that's a damn strong indication that the drug worked. Now, would we like a more significant population? Sure, if it didn't mean people wouldn't die to test it. Medical ethics being what they are, this is strong enough to end the test and look to help the folks getting the placebo. I'm sure you don't mean you want people to needlessly die so you feel "confident"

All well and good if your only criteria for measuring success is the drugs impact on Covid-19 hospitalisations.

Emergency Use Approval should be as its definition says - for Emergency Use.

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26 minutes ago, Raz&#x27;r said:

10 < P < 1.0 Þ insignificant evidence against H0

.05 < P ≤ .10 Þ marginally significant evidence vs. H0

.01 < P ≤ .05 Þ significant evidence against H0

   0 < P ≤ .01 Þ highly significant evidence against H0

While you are educating us all on the significance of p-values explain the relationship to sample size. 

The null hypothesis in this case is presumably - The hospitalisation rate is not changed by the use of this drug.

Now the sample size may be sufficient to prove or disprove that hypothesis however in my opinion it is not large enough to determine other affects of the drug.

In a clinical sense where Covid infected individuals are experiencing serious illness then the emergency use of this drug based on the trial may be warranted.

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if the drug was brought from another company  .. as somebody stated but i have no link for proof

 

that would / could change the approval process and numbers required for a statistical and safety trial

assuming they heard of if when or after it had  gone through the safety phase and they only need approval to use as a c19 treatment

in which case the size of the trial is more than enough to give the results required to approve it as an effective c19 treatment

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2 hours ago, Kate short for Bob said:

So @EYESAILOR what is your view on Ronapreve?  The Regeneron drug that has been tested on many many thousands an shown to reduce hospitalisations by 70%

Kate I think it is very effective.   CT was one of the early users on a compassionate basis and subsequently on the EUA.

It is not called Ronapreve in the US (I think that is the name Roche are using). 

1. This is NOT an antiviral.  It is colloquially known as a monoclonal antibody cocktail. Think of it as a last minute vaccine, if your immune system is not producing enough antibodies. 

2. The phase 3 trial size was 799 patients (including placebo).

3. One issue is cost.  Regeneron charge USD 2.100 per dose to the government because it is expensive and difficult to manufacture. The US has spent $5.6 bn on 2.6 million doses.  M'vir is being sold at $705 per course of treatment.

4. Another difference is it is delivered intravenously but must be done prior to hospitalization to be effective. That causes some challenges.

The results of the trial were good and all I have heard from front line physicians is favorable. It is unsuitable for KSB because it has all the characteristics of a vaccine, the trial size for the EUA was 799 (unacceptably small for KSB), and it is novel.

 

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2 hours ago, Kate short for Bob said:

Where do you get the 695 + 695 from?  It wasn't mentioned in either of the first two links you posted.  As for the being toxic - I quoted directly from your links. 

My opinion is the trial is too small - you have a different opinion.  If you have other data then fine but your headline and the links you reported were based on the following number of trial participants.  The second link stated this:

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012.

 Thank you for correcting your prior post.  All of the data I quoted can be calculated from the release from Merck.  You just quoted back to me, exactly almost word for word much of what I wrote.  The approximate number of trial patients who had not reached the 29 day period is in there if you look.

With a p-value of 0.0012 (which takes account of sample size), would you agree that the results were significant?

I find it somewhat amusing that you think the trial sizes of the vaccines were statistically larger at the time of their filings/ applications.   Do you understand the key variables for determining sample sizes for trial cohorts?  Do you realize why a  vaccine trial with 43,000 participants may in fact be statistically similar or even smaller to judge efficacy as a trial for treatment with 750 participants.

Here is an example. In the Pfizer vaccine phase 3 trial 170 candidates contracted covid. You need a large initial sample to get that kind of infection exposure. The results of the trial hinged on how many of those 170 candidates were vaccinated and how many were unvaccinated. In the antiviral trials we use much smaller populations because (rather like a challenge trial) we are selecting candidates who have covid and are high risk. In the antiviral trial 762 candidates had contracted covid.  The results of the trial hinged on how many of the candidates were subsequently hospitalized or died. 

In the Pfizer trial 9 candidates in the entire placebo population were hospitalized. In the antiviral trial 53 patients in the control group were hospitalized. The control group in the antiviral trial was approximately 5x larger to study the impact of the drug on hospitalization.

A p value of 0.0012 on a large sample size (created by selecting high risk patients who already have covid) is powerful data.

 If you test a cancer drug on the general population you will need a large sample because many will not have cancer. If you test it on a population of severely ill cancer patients, and it reduces mortality by 50% then a sample size of 100 would likely  give you very strong data.

Hope that helps.  You are flying in the face of good science trying to find fault with the results of this trial.

 

 

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1 hour ago, Kate short for Bob said:

In a clinical sense where Covid infected individuals are experiencing  at risk of serious illness then the emergency use of this drug based on the trial may be warranted.

Its too late if they have already gone into the ICU. 

If you can acknowledge that some patients are at high risk if they start demonstrating moderate covid symptoms, then I think you have arrived at  the right place.

Phew. 

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2 hours ago, Kate short for Bob said:

While you are educating us all on the significance of p-values explain the relationship to sample size. 

The null hypothesis in this case is presumably - The hospitalisation rate is not changed by the use of this drug.

Now the sample size may be sufficient to prove or disprove that hypothesis however in my opinion it is not large enough to determine other affects of the drug.

In a clinical sense where Covid infected individuals are experiencing serious illness then the emergency use of this drug based on the trial may be warranted.

Well, progress. Given it’s only tested on people admitted to the hospital, yeah, that’s serious illness

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If you want to "follow the money", it is not Merck that is going to make the truly earth shattering money from this drug but a rather unique hedge fund husband and wife team, Dr Wayne Holman and Wendy Holman , who bought the rights as the pandemic started.

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On 10/5/2021 at 9:52 AM, EYESAILOR said:

Kate,

What are the other anti-virals that you consider equal worthy to Mvir in the treatment of covid?

@Kate short for Bob.........Still waiting for that list of "other antivirals equally worthy"

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On 10/6/2021 at 4:41 PM, EYESAILOR said:

If you want to "follow the money", it is not Merck that is going to make the truly earth shattering money from this drug but a rather unique hedge fund husband and wife team, Dr Wayne Holman and Wendy Holman , who bought the rights as the pandemic started.

Not entirely true the way you have stated it.  They initially bought the rights from a University but hen not securing Government contracts they then sold the rights to Merck.  They still receive some payments however the Merck has all the power now.

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@EYESAILOR is it true that the active ingredient in Molnupiravir was abandoned by a company called Pharmasset in 2003 due to it being mutagenic?

Is it true that Emory University made minor changes to this drug which it calls EIDD-2801?

But essentially it is the same drug and its main metabolite that showed mutagenic and toxicity in earlier trials. 

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10 minutes ago, slug zitski said:

I got to the part where they started cheerleading for ivermectin as a covid therapy and realized it was just pure bullshit like all the other ivermectin bullshit.  When are people going to give up on ivermectin?  If it was useful, it would be getting used in covid care.   Doctors and nurses want to save their patients and will try anything that is justified by science to save them.

They aren't trying ivermectin.   It isn't a conspiracy against ivermectin, it just doesn't help the patients.  

Please don't post any more ivermectin bullshit.  It will be reported.  A few folks have been flicked for publishing misinformation on these forums.  

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5 minutes ago, Rain Man said:

I got to the part where they started cheerleading for ivermectin as a covid therapy and realized it was just pure bullshit like all the other ivermectin bullshit.  When are people going to give up on ivermectin?  If it was useful, it would be getting used in covid care.   Doctors and nurses want to save their patients and will try anything that is justified by science to save them.

They aren't trying ivermectin.   It isn't a conspiracy against ivermectin, it just doesn't help the patients.  

Please don't post any more ivermectin bullshit.  It will be reported.  A few folks have been flicked for publishing misinformation on these forums.  

Be my guest 

report it 

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23 minutes ago, The Main Man said:

Ivectermin not so great after all…

https://www.bbc.co.uk/news/health-58170809

 

Definitely worth a read.  It is a good summary of why ivermectin supporters are wrong when they claim there is science that says it is effective against covid.

From the article:

"The largest and highest quality ivermectin study published so far is the Together trial at the McMasters University in Canada. It found no benefit for the drug when it comes to Covid."

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As the docs are administering molnupiravirthis they will need to whisper "It's ivermectin" to the anti-vaxxers whose sorry asses they are trying to save.  Already the anti-vaxx crusaders are defending their miracle drug ivermectin and claiming molnopiravirthis "has no science to support it".  Oh, the irony.

 

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30 minutes ago, Rain Man said:

As the docs are administering molnupiravirthis they will need to whisper "It's ivermectin" to the anti-vaxxers whose sorry asses they are trying to save.  Already the anti-vaxx crusaders are defending their miracle drug ivermectin and claiming molnopiravirthis "has no science to support it".  Oh, the irony.

 

Remember the debate last year on Hydroxychloroquine?

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3 hours ago, Kate short for Bob said:

@EYESAILOR is it true that the active ingredient in Molnupiravir was abandoned by a company called Pharmasset in 2003 due to it being mutagenic?

Is it true that Emory University made minor changes to this drug which it calls EIDD-2801?

But essentially it is the same drug and its main metabolite that showed mutagenic and toxicity in earlier trials. 

Oh Noes.

 

Available data suggest that molnupiravir acts as a mutagenizing agent that causes an ‘error catastrophe’ during viral replication 

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1 hour ago, ShortForBob said:

Oh Noes.

 

Available data suggest that molnupiravir acts as a mutagenizing agent that causes an ‘error catastrophe’ during viral replication 

It was just yesterday that you were chastising somebody about accrediting quotes.

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