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First Effective Treatment Imminent


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The “little” company is publicly traded on NYSE and has a capitalization in excess of 6 billion and sort of has a lengthy history of phase 2/3 trials that peters out.  what I’m saying is... a lot

Can I buy this stock using the Hydroxychloroquine futures I bought a few weeks ago? The future contracts are printed on super high quality paper so should be worth something.

There are dozens of multi-billion dollar ethical and bio-technical pharmaceutical companies in the world with thousands of researchers and physicians working for them with decades of experience, but r

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1 hour ago, Albatros said:

im·mi·nent | \ ˈi-mə-nənt

\

Definition of imminent

 

: ready to take place : happening soon

Well - they have the drug available along with manufacturing so they are ready to hand it out....

 

Next opportunity for FDA to approval will most likely come in October at the 45% trial mark. If it demonstrates superior efficacy, then the trial will be halted and it will be immediately approved. Given the USA and many other places are now going into winter, cases are set to rise again and they should find recruitment faster hopefully.

 

To show superior efficacy at 45%, they don't just need to change the mortality rate by a small amount, they need a huge difference something like a 40% difference. So if 60% on placebo die. then if under 20% die that were treated, it may classify for superior efficacy.  Ie, it reduces the mortality rate by something like 60% or greater. That is what is expected based off the initial emergency access results too by the way. 

 

They are also one of the few treatments approved for, and have treated children with  MISC who have recovered abnormally well afterwards.

 

 

 

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^^^^^^^^^^^^^^^^^^^^^^

Vogon poetry is the third worst in the Universe. The second worst is that of the Azgoths of Kria, and the worst is by Paula Nancy Millstone Jennings of Sussex, who perished along with her poetry during the destruction of Earth, ironically caused by the Vogons themselves. Vogon poetry is seen as mild by comparison.

Oh freddled gruntbuggly,
Thy micturations are to me, (with big yawning)
As plurdled gabbleblotchits, in midsummer morning
On a lurgid bee,
That mordiously hath blurted out,
Its earted jurtles, grumbling
Into a rancid festering confectious organ squealer. [drowned out by moaning and screaming]
Now the jurpling slayjid agrocrustles,
Are slurping hagrilly up the axlegrurts,
And living glupules frart and stipulate,
Like jowling meated liverslime,
Groop, I implore thee, my foonting turlingdromes,
And hooptiously drangle me,
With crinkly bindlewurdles,mashurbitries.
Or else I shall rend thee in the gobberwarts with my blurglecruncheon,
See if I don't!
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9 minutes ago, Albatros said:

^^^^^^^^^^^^^^^^^^^^^^

Vogon poetry is the third worst in the Universe. The second worst is that of the Azgoths of Kria, and the worst is by Paula Nancy Millstone Jennings of Sussex, who perished along with her poetry during the destruction of Earth, ironically caused by the Vogons themselves. Vogon poetry is seen as mild by comparison.

Oh freddled gruntbuggly,
Thy micturations are to me, (with big yawning)
As plurdled gabbleblotchits, in midsummer morning
On a lurgid bee,
That mordiously hath blurted out,
Its earted jurtles, grumbling
Into a rancid festering confectious organ squealer. [drowned out by moaning and screaming]
Now the jurpling slayjid agrocrustles,
Are slurping hagrilly up the axlegrurts,
And living glupules frart and stipulate,
Like jowling meated liverslime,
Groop, I implore thee, my foonting turlingdromes,
And hooptiously drangle me,
With crinkly bindlewurdles,mashurbitries.
Or else I shall rend thee in the gobberwarts with my blurglecruncheon,
See if I don't!

Where is my damn towel??  

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It is a sad state of affairs in the 21st Century where the quickest state of the art treatment takes 6 months to go through an approval process.... meanwhile potentially the lockdown fate of most of the world is waiting...

 

Pluristem are expecting to finish enrollment for their stem cell PHASE 2 trial by the end of Q1 in 2021

Athersys  who had already tested their treatment successfully for ARDS in a phase 1/2 trial that finished in May 2019 ( before Covid ), Started their COVID ARDS trial at the same time as Mesoblast, and are expecting it to finish Primary end points in September 2021

Mesoblast has stated they expect primary completion by the end of Q4 2020, with a possible early termination at the 30/45/60% mark also an option.

 

They will still be first to the pin by a country mile... you can't rush evidence though I'm afraid. Too many people think it's snake oil and need to be proven beyond 95% that it isn't.   :)

 

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7 hours ago, dachopper said:

It is a sad state of affairs in the 21st Century where the quickest state of the art treatment takes 6 months to go through an approval process.... meanwhile potentially the lockdown fate of most of the world is waiting...

Pluristem are expecting to finish enrollment for their stem cell PHASE 2 trial by the end of Q1 in 2021

Athersys  who had already tested their treatment successfully for ARDS in a phase 1/2 trial that finished in May 2019 ( before Covid ), Started their COVID ARDS trial at the same time as Mesoblast, and are expecting it to finish Primary end points in September 2021

Mesoblast has stated they expect primary completion by the end of Q4 2020, with a possible early termination at the 30/45/60% mark also an option.

 

They will still be first to the pin by a country mile... you can't rush evidence though I'm afraid. Too many people think it's snake oil and need to be proven beyond 95% that it isn't.   :)

 

What a perfectly welcome state of affairs it is that the proposed injection of novel bio-active substances - for profit - into human bodies takes many, many months of rigorous investigation, testing, and proving before it is acceptable for use on a global scale. 

Pump and dump specialists may disagree.

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7 hours ago, dachopper said:

It is a sad state of affairs in the 21st Century where the quickest state of the art treatment takes 6 months to go through an approval process

Only if you don't give a fuck about killing patients and only care about stock price.

 

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2 minutes ago, MR.CLEAN said:

Only if you don't give a fuck about killing patients and only care about stock price.

 

And 6 months isn’t even true - the data just isn’t there to support a rapid approval. If his claims from his first post were actually grounded in fact, we would have heard about positive results and approval in about 60 days. Now he’s claiming there aren’t enough patients for a double blind and keeps repeating percentage points till completion like he’s rendering a video and the % fluctuates back and forth for unknown reasons. 

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7 hours ago, Albatros said:

^^^^^^^^^^^^^^^^^^^^^^

Vogon poetry is the third worst in the Universe. The second worst is that of the Azgoths of Kria, and the worst is by Paula Nancy Millstone Jennings of Sussex, who perished along with her poetry during the destruction of Earth, ironically caused by the Vogons themselves. Vogon poetry is seen as mild by comparison.

Oh freddled gruntbuggly,
Thy micturations are to me, (with big yawning)
As plurdled gabbleblotchits, in midsummer morning
On a lurgid bee,
That mordiously hath blurted out,
Its earted jurtles, grumbling
Into a rancid festering confectious organ squealer. [drowned out by moaning and screaming]
Now the jurpling slayjid agrocrustles,
Are slurping hagrilly up the axlegrurts,
And living glupules frart and stipulate,
Like jowling meated liverslime,
Groop, I implore thee, my foonting turlingdromes,
And hooptiously drangle me,
With crinkly bindlewurdles,mashurbitries.
Or else I shall rend thee in the gobberwarts with my blurglecruncheon,
See if I don't!

And here I thought it Rudyard Kipling's:

Take up the White Man's burden—
    Send forth the best ye breed—
Go bind your sons to exile
    To serve your captives' need;
To wait in heavy harness
    On fluttered folk and wild—
Your new-caught, sullen peoples,
    Half devil and half child.

Take up the White Man's burden—
    In patience to abide,
To veil the threat of terror
    And check the show of pride;
By open speech and simple,
    An hundred times made plain.
To seek another's profit,
    And work another's gain.

Take up the White Man's burden—
    The savage wars of peace—
Fill full the mouth of Famine
    And bid the sickness cease;
And when your goal is nearest
    The end for others sought,
Watch Sloth and heathen Folly
    Bring all your hopes to nought.

Take up the White Man's burden—
    No tawdry rule of kings,
But toil of serf and sweeper—
    The tale of common things.
The ports ye shall not enter,
    The roads ye shall not tread,
Go make them with your living,
    And mark them with your dead!

Take up the White Man's burden—
    And reap his old reward:
The blame of those ye better,
    The hate of those ye guard—
The cry of hosts ye humour
    (Ah, slowly!) toward the light:—
"Why brought ye us from bondage,
    Our loved Egyptian night?"

Take up the White Man's burden—
    Ye dare not stoop to less—
Nor call too loud on Freedom
    To cloak your weariness;
By all ye cry or whisper,
    By all ye leave or do,
The silent, sullen peoples
    Shall weigh your Gods and you.

Take up the White Man's burden—
    Have done with childish days—
The lightly proffered laurel,
    The easy, ungrudged praise.
Comes now, to search your manhood
    Through all the thankless years,
Cold-edged with dear-bought wisdom,
    The judgment of your peers!

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5 hours ago, Left Shift said:

What a perfectly welcome state of affairs it is that the proposed injection of novel bio-active substances - for profit - into human bodies takes many, many months of rigorous investigation, testing, and proving before it is acceptable for use on a global scale. 

Pump and dump specialists may disagree.

You welcome the state of affairs, the lockdowns, the travel bans, the millions of deaths that have occurred as a result of this ? You are nuts.

It's not a problem faced by this company alone, there are other options that are equally delayed months / years / decades because of the draconian science measures, and the almost mandatory placebo controlled trial.....Really in the 21st century we have to treat some people with saline and then watch them die before we can say - ok this works. Yay for human kind. Why can't a single arm trial be acceptable in the 21st century. 

 

On face value under normal circumstances that don't involve the entire earth stopping then many months of testing might be acceptable, but they are talking about injecting a novel bio-active substance that came from within a person, and resides within all people, that has a perfect safety record, an understood mechanism of action after over 2000 injections in children  / adults and the elderly.....after over 10 years of research & development. It's not battery acid or bleach or some other concocted molecule, or vaccine made be humans, placed into a virus in a lab

I mean if you have ever received a live blood transfusion you would have received some of these cells by default.

 

 When the drug proves that it does save people, yet hundreds of thousands have died wile it was going through yet more rounds of clinical trials... who exactly are the ignorant people that held up a safe therapy that didn't give a fuck about about killing people ?????

 

The FACT is for this company, this drug already has pre-existing FDA Fast Track Designation before covid.  It's due to be approved for use and for sale in the USA by the end of September this month. That is the same drug they now have to do more trials, full double blind placebo control randomised trials for.  I dare say, had the FDA said a single arm would be sufficient that  it would already be completed by now. When you are on deaths bed and the prognosis is that you will most likely die, and you have been offered an experimental treatment where there is a 50% chance you will receive saline and die.... there are a lot of people that would try and pick a different trial that has no saline arm, and there are thousands of trials trying different therapies / vaccines available without a placebo control.

https://www.globenewswire.com/news-release/2020/02/03/1978576/0/en/Mesoblast-Submits-Completed-Biologics-License-Application-for-Ryoncil-to-US-FDA.html  

 

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See, see the dachopper sky
Marvel at its big voidoid depths.
Tell me, covid do you
Wonder why the mumblefuck ignores you?
Why its foobly stare
makes you feel leek.
I can tell you, it is
Worried by your brumbleweed facial growth
That looks like
A azok.
What's more, it knows
Your babyborrel potting shed
Smells of warthog.
Everything under the big dachopper sky
Asks why, why do you even bother?
You only charm dachopper.

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Buffalo Bill's
        defunct
               who used to
               ride a watersmooth-silver
                                        stallion
        and break onetwothreefourfive pigeonsjustlikethat
                                                         Jesus
        he was a handsome man
                             and what i want to know is
        how do you like your blueeyed boy
        Mister Death
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  • 2 weeks later...
On 5/10/2020 at 9:37 AM, dachopper said:

I've been doing some research on the potential ways out of this lockdown mess and back to normality, and discovered the little Aussie company that could ( Mesoblast ) - are in the middle of a US trial that looks like it's as close to a guaranteed done deal in reducing Covid caused deaths as you can get before a trial end date. They have a treatment of cells that they were in the final  stages of getting approved for use in the USA targeting steroid refractive Graft verses Host disease - which there is no treatment for, and has all ready shown fantastic results ( GVHD is where your own immune system attacks / kills you after receiving a transplant. Steroids are the only treatment but they do not work in about 40% of cases   ). 

As it turns out - the main killing mechanism they observe from Covid , appears to be the Hyper immune response, and the body killing itself also ( cytokine storm ).

So far they have treated 12 people on compassionate grounds who were seriously ill, on ventilators, some with multiple organ failure, some on ventilators for 2 weeks solid prior to being treated, and had a recovery rate of 83% or 10 / 12 people.. The recovery rate in the hospital during that same period for ventilated patients was under 12% ( 88% died ).

They are now about 1 week into the final trial that is necessary to prove that the treatment works, as a proper medical trial with patients getting treated with maximum care standard + either placebo or the cells. The trial has a primary endpoint of survival at 30 days, and also at 7 and 14 days along with other measurements. 33% of the way through the trial, if it is observed that the treatment is overwhelming effective ( which is expected by the compassionate use and other data ) - Then the FDA can approve immediate treatment before the trial has completed.

What is interesting is that Mesoblast by co-incidence were already ramping up production of the cells massively in preparation of their US product launch Ryoncil, and they have stated that they are in a good position to be capable of treating as many critical patents as is needed.

They also have some different cells that are completing their last phase 3 trial next month for lower back pain ( disc regeneration ) / and heart failure which also both look like they are primed for excellent results. 

 

If they show with the large trial what they did with the 12 critically ill patients, then we are going to be reducing COVID deaths to a level lower than seasonal Flu.... Also the product can treat seasonal Flu aswell..... Fingers crossed we here good news by the end of the month. or some time in June.  


If I need a laugh I just quote the post that started it all that had the confidence of someone who admitted later he has no SME in biology, biomedical research or medicine. 

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Great quote from the CEO

Chief executive Silviu Itescu said he believed the request for more data would set the company's planned launch of the product back "somewhere in the order of 3 to 5 months".”

it certainly wasn’t going to speed it up.  Right up they with the weather girl saying we should have seen the last of the September rains on the news on September 30th.

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3 hours ago, SCARECROW said:

Great quote from the CEO

Chief executive Silviu Itescu said he believed the request for more data would set the company's planned launch of the product back "somewhere in the order of 3 to 5 months".”

it certainly wasn’t going to speed it up.  Right up they with the weather girl saying we should have seen the last of the September rains on the news on September 30th.

That was the same product, but for a different treatment. I wouldn't be surprised if there is litigation involved if it's not sorted next month. Safe product that saved childrens lives in the last trial, but FDA doesn't understand or believe the company understands how it works  so they decide not to approve it. Pity for the children that have no alternative !

It will certainly muddy the waters if the COVID trial comes back also positive and safe, and the FDA blocks it for the same reason. They even disagreed with their own  panel of experts who voted 9 to 1 that it works, and told the company there is no evidence it works.

Clearly - there must be a hidden agenda there! 

 

 

  

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2 minutes ago, El Boracho said:

Clearly - this is but one more in a long sad history of failures for Mesoblast. Press releases and stock bumping do not make a successful pharma company.

Your right on that one for now, not just them, all Donor stem cell companies and the FDA. Lets see how the Type A meeting goes at the beginning of November still could turn out to be a world first.

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On 10/3/2020 at 12:30 PM, dachopper said:

Lets see how the Type A meeting goes at the beginning of November still could turn out to be a world first.

Let's hope you didn't sink Granny's pension into it, and that you are young enough to recover from being the 490 millionth person to get suckered by a pharmaco.

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  • 4 weeks later...
On 10/6/2020 at 11:18 PM, MR.CLEAN said:

Let's hope you didn't sink Granny's pension into it, and that you are young enough to recover from being the 490 millionth person to get suckered by a pharmaco.

Clean you will love this.

State sponsored insider trading.

 

Click to continue.

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On 11/4/2020 at 1:21 AM, Albatros said:

imminent

Yep - 45% DMC readout next week. 

Fingers crossed it works because plainly nothing else has. 

Unfortunately for them to stop the trial this early though - they will need something like 60% + controls mortality,  and under 10% treated mortality. Otherwise will need to wait for the 60 or full treatment to finish  

 

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1 hour ago, dachopper said:

Yep - 45% DMC readout next week. 

Fingers crossed it works because plainly nothing else has.

First Effective Lawsuit Imminent! The pump and dumpers will get to explain their lies in court:

LAWSUITS FILED AGAINST MESO

Quote

The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (1) comparative analyses between Mesoblast's Phase 3 trial and three historical studies did not support the effectiveness of the Company's lead product candidate, remestemcel-L, for steroid refractory acute graft versus host disease due to design differences between the four studies...

 

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I'm kind of chuckling at how this thread was so obviously bullshit from the get go - "random guy with admittedly no basic biology, medicine or clinical trial exp" says he found a "little australian company that could" blah blah blah stem cell imminent blah blah blah done deal. Posts bunch of unrelated studies and some even from within the PRC BEFORE covid19 was even publicly acknowledged as human to human transmission. 

lol

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3 hours ago, dachopper said:

Yep - 45% DMC readout next week. 

Fingers crossed it works because plainly nothing else has. 

Unfortunately for them to stop the trial this early though - they will need something like 60% + controls mortality,  and under 10% treated mortality. Otherwise will need to wait for the 60 or full treatment to finish   

 

that's very much dadaism, like :

else week mortality 60 trial though
will controls something for under dmc
the to because early finish 60
nothing it stop next works them
yep or readout mortality will need
full plainly like wait to treated
this fingers and has 10 otherwise
unfortunately crossed to 45 for the
treatment need they

or vogon, like :

dachopp.PNG.f5b9067db32fc818990961fe98cd631e.PNG

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Nothing like a little lack of training, knowledge or experience to let you be the first to recognize scientific glory (and associated big bucks).  

On 11/5/2020 at 5:01 PM, Varan said:

 

Answer:  "DaChopper"

Question:  Name a person who did not invest in Pfizer.

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12 hours ago, Left Shift said:

Nothing like a little lack of training, knowledge or experience to let you be the first to recognize scientific glory (and associated big bucks).  

Answer:  "DaChopper"

Question:  Name a person who did not invest in Pfizer.

Invest in Pfizer....   The CEO doesn't seem to agree with your assessment.

Selling 60% of his stock at the yearly high before it came back to where it is now.

 

Back on topic - Mesoblast recommended to continue from the Data Monitoring Committee reviewing the 45% recruited mark today.

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  • 2 weeks later...

https://www.novartis.com/news/media-releases/novartis-secures-exclusive-rights-potential-acute-respiratory-distress-syndrome-cell-therapy

 

So Novartis have just agreed to pay around 1.8 Billion AUD for the snake oil in this 'scam' as some of you have called it.

 

The good news is - the scale up and distribution can now happen much quicker with Novartis funding the Capex and using their existing distribution channels

The bad news is - 60% readout won't be until the end of December by my guess, and trial completion of primary endpoint - at which time they can go for Emergency Access Use, is going to happen around Feb 2021, also at which point the lesser educated opinions will be put to bed.

 

 

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At which point we will have vaccines widely available and Covid-19 will be a minor disease.

Just caught the end of the CEO interview on FOX Business, looked a little worn out to me.

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33 minutes ago, TheDragon said:

At which point we will have vaccines widely available and Covid-19 will be a minor disease.

Just caught the end of the CEO interview on FOX Business, looked a little worn out to me.

Not to mention the Novartis deal looks like a bailout.

Novartis will make a $25 million upfront payment and invest $25 million in Mesoblast equity with additional payments and royalties due on achievement of agreed development, regulatory and commercial milestones. In addition, Novartis will provide certain support to enable commercial manufacturing scale-up. Novartis has the option, if exercised, to distribute remestemcel-L for graft versus host disease (GVHD) (outside Japan). Both parties have rights to co-fund development and commercialization for other non-respiratory indications. The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

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7 hours ago, Miffy said:

Not to mention the Novartis deal looks like a bailout.

Novartis will make a $25 million upfront payment and invest $25 million in Mesoblast equity with additional payments and royalties due on achievement of agreed development, regulatory and commercial milestones. In addition, Novartis will provide certain support to enable commercial manufacturing scale-up. Novartis has the option, if exercised, to distribute remestemcel-L for graft versus host disease (GVHD) (outside Japan). Both parties have rights to co-fund development and commercialization for other non-respiratory indications. The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions.

Pocket change to a company like Novartis.  Probably 1/10th the CEO's golden parachute.  

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10 hours ago, TheDragon said:

At which point we will have vaccines widely available and Covid-19 will be a minor disease.

Just caught the end of the CEO interview on FOX Business, looked a little worn out to me.

If you call over 100,000 deaths annually 'Minor ' That's worse than influenza which we have vaccinations for.

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4 hours ago, Varan said:

This imminent thread started on May 10th. Over six months later, people are still dying from covid-19. Just saying..

Its unfortunate, the drug has not been developed from scratch like the vaccines have. It was allready good to go and has not changed since May. Its taken this long to give the FDA what they need before they will approve- and its not there yet either. 

I see there is still no alternative treatment once you progress to ARDS... better now than never. 

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On 11/23/2020 at 3:49 AM, dachopper said:

So Novartis have just agreed to pay around 1.8 Billion AUD for the snake oil in this 'scam' as some of you have called it.

"Novartis will make a $25 million upfront payment and invest $25 million in Mesoblast equity with additional payments and royalties due on achievement of agreed development, regulatory and commercial milestones"

Not QUITE 1.8 Billion.  That's basically "hmm we're interested; here is some pocket change to keep you afloat"

 

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9 hours ago, El Boracho said:

Moderate success with any one of the vaccine candidates will flick MESO back into obscurity. Useful therapy, perhaps, but tiny market.

It is a possibility .... one of the vaccines could be 100 % effective, and 100% of the human race may get vaccinated every 3 months for the rest of their lives........

 

or more likely just like as is reality for the multiple influenza vaccines available - the effectiveness decreases every time the virus mutates, and way under half the population will get innoculated, with hundreds of thousands still dying annually.

 

On the Novartis deal - it really is huge, and probably what the company needed to and tackle ARDS

50 million USD up front

505  million USD in pre-commercialization milestone payments for treatment of ARDS

750 million USD  post commercialization milestone payments linked with sales etc

A Novartis  fully funded ARDS trial to target US and European markets by Novartis pending a good phase 3 covid US results

Double digit royalties on all sales

50/50 Cost / profit share option for all future expansion for new treatments

Payment for all footprint / manufacturing expansion  capex by Novartis for Mesoblast

MSB keeps all rights for GvHD

Another 50 million USD for progress in 3d Bioreactor use and the removal of fetal bovine serum during manufacturing process 

 

They are in a stronger position now than they were last week - with what sounds like the right sort of deal to be able to deliver the treatment as fast as they possibly could. Company initially mentioned a ramp up to deliver 10,000 treatments by June 21 ( that was before the partnership ). That could potentially represent 50 - 100,000 patients per annum after June 21, and if the vaccines are effective then that may be enough.  ( requiring 1 donor every 2 days ) 

Without an effective vaccine - there is big trouble in trying to meet the demand, hence the partnership. if you took today's Ventilated numbers, of 4000 people per day..... that is 1.5 million treatments per year., requiring I think 400 Donors per treatment with current leading edge technology. Which ends up being 10 Donors per day - which is an absolutely  Massive operation. 

 

On the plus side - if this treatment works for Covid-19, it will finally signal  the monumental shift in medicine treatments as we move away from poisonous single target chemical compounds, and finally start to understand how to use living cells from people who don't get sick , and heal faster - to help everyone else.

 

 

 

 

 

 

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On 11/25/2020 at 2:41 PM, dachopper said:
On 11/25/2020 at 5:17 AM, El Boracho said:

Moderate success with any one of the vaccine candidates will flick MESO back into obscurity. Useful therapy, perhaps, but tiny market.

It is a possibility .... one of the vaccines could be 100 % effective, and 100% of the human race may get vaccinated every 3 months for the rest of their lives........

Starts rolling out next week.....the Meso flick is now starting. 

 

 

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5 hours ago, jack_sparrow said:

Starts rolling out next week.....the Meso flick is now starting. 

 

 

That is great news, 

 

Mesoblast also just got fast track approval from the FDA today, based off the results @Miffy was " lying " about  - hopefully we get several effective  vaccines, and multiple treatments that works without side effects....  

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4 hours ago, BlatantEcho said:

It's pretty interesting to see the FDA not do rolling data review, like the UK did here.

More interesting is if US prepared to let manufacturer off the liability hook and leave it's citizens carrying all the risk. 

Hey who gives a fuck then if approvals might be a bit rushed. 

Coronavirus vaccine: Pfizer given protection from legal action by UK government

"TheThe Department of Health and Social Care has confirmed the company has been given an indemnity protecting it from legal action as a result of any problems with the vaccine."

Then the Govt indemnify themselves. 

4th bullet point and the exemption 

  EoRTo48W4AEHqP-.jpeg

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3 hours ago, jack_sparrow said:

More interesting is if US prepared to let manufacturer off the liability hook and leave it's citizens carrying all the risk. 

Hey who gives a fuck then if approvals might be a bit rushed. 

Coronavirus vaccine: Pfizer given protection from legal action by UK government

"TheThe Department of Health and Social Care has confirmed the company has been given an indemnity protecting it from legal action as a result of any problems with the vaccine."

Then the Govt indemnify themselves. 

4th bullet point and the exemption 

  EoRTo48W4AEHqP-.jpeg

I don't blame them - look what happened with the swine flue vaccine. Now governments all over the world are successfully being forced to compensate all the people now stuck with narcolepsy.

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1 hour ago, dachopper said:

I don't blame them - look what happened with the swine flue vaccine. Now governments all over the world are successfully being forced to compensate all the people now stuck with narcolepsy.

lol you read one article about Sweden and now "governments all over the world are being forced to compensate all the people"

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There is a treatment for Covid-19 but only for the wealthy.

Giuliani says he didn't know most Americans can't access his VIP coronavirus treatment regimenDECEMBER 9, 2020
https://www.salon.com/2020/12/09/giuliani-says-he-didnt-know-most-americans-cant-access-trumps-vip-coronavirus-treatment-regimen/

Quote

Like Trump, Giuliani has been treated with remdesivir and dexamethasone, which one of the radio hosts pointed out is too expensive for ordinary Americans.

"I, well, I didn't know that. I mean, they give it to us here at this hospital," Giuliani told the radio hosts.
[...]
After being diagnosed with COVID-19, Trump was given the steroid dexamethasone to address his lowered oxygen levels; a five-day course of the antiviral drug remdesivir that is meant to improve recovery time for patients; and an 8 gram dose of an experimental drug called REGN-COV2 from the biotechnology company Regeneron.

The treatment that President Trump got is certainly not available to all patients, Dr. Georges Benjamin, executive director of the American Public Health Association, told Salon by email in October. Benjamin's views were echoed at the time by Dr. Richard D. Wolff, professor emeritus of economics at the University of Massachusetts Amherst.

"Privilege is the key adjective to describe not only the medical care Trump is now receiving but the entire package of first-rate health care provided freely to top officials, the Congress, etc," Wolff wrote to Salon. 

 

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I think dexamethasone  and REGN-COV2 are probably the best options out there currently on the treatment front * if they are available. With the discovery of long covid symptoms recently though and long term side effects, I am waiting patiently for msb to finish their trial. The benefit for all being that their treatment is regenerative and hopefully will stop long covid symptoms all together, unlike single use therapies like dexameth or antibodies.

 

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  • 2 weeks later...

Well.....  This isn't such good news, unlikely to reduce mortality by 43% - actual mortality reduction is unknown.

Trial has been halted at about 75% enrolled, results will be now unblinded after mid February - hopefully it shows some form of efficacy and they can correlate why it started out showing good efficacy, but then reduced for patients enrolled Oct - Nov.

Still worth keeping an eye on.

http://investorsmedia.mesoblast.com/static-files/bc0ce366-1c50-46ce-a9d4-d06b7ce403e5

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Three days ago the FDA approved the first over-the-counter COVID-19 test.  Why were vaccines developed and approved more quickly than this test?

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19December 15, 2020
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic

Quote

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. 

But the fine print explains the intrusive string attached - Big Brother gets your test results!!

Quote

Test results from your product will be automatically reported to relevant public health
authorities, via your product’s software application
(app), in accordance with local, state, and
federal requirements, using appropriate LOINC and SNOMED codes, as defined by the
“Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests”
provided by the Centers for Disease Control and Prevention (CDC).

Your product includes a single use Analyzer and a single use sampling and processing system
that includes a sterile Nasal Swab with a child adapter, Processing Fluid, and a Dropper. To use
your product the user must first download the Ellume COVID-19 Home Test App for iOS or
Android phones
. The user follows the instructions on the Quick Start Guide included in the kit
box to connect the Analyzer to their phone. The user then views an informational video and
follows the in-app self-paced, step-by-step instructions to complete the test.

 

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10 hours ago, ProaSailor said:

Three days ago the FDA approved the first over-the-counter COVID-19 test.  Why were vaccines developed and approved more quickly than this test?

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19December 15, 2020
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-antigen-test-first-over-counter-fully-home-diagnostic

But the fine print explains the intrusive string attached - Big Brother gets your test results!!

 

Of course they do.

What's freedom?

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On 12/23/2020 at 10:40 AM, Miffy said:

good to know even with covid, the bullshit smell detector still works even if you can’t smell or taste anything. 

If it starts to let you down I’ve been hearing about a great Stem cell based treatment for failed bullshit smell detectors. It’s still in the prelim testing stage and they’re looking for investors but initial results are promising and data will be out soon.

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On 12/24/2020 at 12:16 PM, SCARECROW said:

If it starts to let you down I’ve been hearing about a great Stem cell based treatment for failed bullshit smell detectors. It’s still in the prelim testing stage and they’re looking for investors but initial results are promising and data will be out soon. is imminent

FIFY

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  • 4 months later...

Topline results finally out. 75% reduction mortality in under 65's with dexamethazone, 46% reduction without using dexamethazone...

 

So it looks like it works, they will probably modify the dose or frequency for over 65's and get better results.

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1 hour ago, dachopper said:

Topline results finally out. 75% reduction mortality in under 65's with dexamethazone, 46% reduction without using dexamethazone...

 

So it looks like it works, they will probably modify the dose or frequency for over 65's and get better results.

Or to be clearer... in the study done using dexamethazone on ventilated patients, dexamethazone + standard of care reduced mortality by approx 30%. Mesoblast treatment without dexamethazone but with standard of care reduced mortality by around 45%  while mesoblast with dexamethazone and standard of care showed around a 75% reduction in mortality compared to the placebo arm with standard of care without mesoblast and without dexamethazone.

 

This is fantastic news. I'm hoping they can get approval for a phase 4 to vary the dose and get even better confirmatory results in the over and under 65's. From what I understand they only administered 2 doses of the therapy, whereas the gvhd doseage is 3 or more of 2 doses over time, repeated as directed.

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  • 2 weeks later...
On 5/10/2020 at 7:37 AM, dachopper said:

I've been doing some research on the potential ways out of this lockdown mess and back to normality, and discovered the little Aussie company that could ( Mesoblast ) - are in the middle of a US trial that looks like it's as close to a guaranteed done deal in reducing Covid caused deaths as you can get before a trial end date. They have a treatment of cells that they were in the final  stages of getting approved for use in the USA targeting steroid refractive Graft verses Host disease - which there is no treatment for, and has all ready shown fantastic results ( GVHD is where your own immune system attacks / kills you after receiving a transplant. Steroids are the only treatment but they do not work in about 40% of cases   ). 

As it turns out - the main killing mechanism they observe from Covid , appears to be the Hyper immune response, and the body killing itself also ( cytokine storm ).

So far they have treated 12 people on compassionate grounds who were seriously ill, on ventilators, some with multiple organ failure, some on ventilators for 2 weeks solid prior to being treated, and had a recovery rate of 83% or 10 / 12 people.. The recovery rate in the hospital during that same period for ventilated patients was under 12% ( 88% died ).

They are now about 1 week into the final trial that is necessary to prove that the treatment works, as a proper medical trial with patients getting treated with maximum care standard + either placebo or the cells. The trial has a primary endpoint of survival at 30 days, and also at 7 and 14 days along with other measurements. 33% of the way through the trial, if it is observed that the treatment is overwhelming effective ( which is expected by the compassionate use and other data ) - Then the FDA can approve immediate treatment before the trial has completed.

What is interesting is that Mesoblast by co-incidence were already ramping up production of the cells massively in preparation of their US product launch Ryoncil, and they have stated that they are in a good position to be capable of treating as many critical patents as is needed.

They also have some different cells that are completing their last phase 3 trial next month for lower back pain ( disc regeneration ) / and heart failure which also both look like they are primed for excellent results. 

 

If they show with the large trial what they did with the 12 critically ill patients, then we are going to be reducing COVID deaths to a level lower than seasonal Flu.... Also the product can treat seasonal Flu aswell..... Fingers crossed we here good news by the end of the month. or some time in June.  

Heh. One year -46%. Burning cash. Imminent nothing. On the plus side they seem to have quit the pump-and-dump scheme.

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