First Effective Treatment Imminent

[12 metre]

No way.

!!!!!!!!!!!!!!! and needs 30,000 people.

I say no problemo!!!!!!!!!!!!!

Moderna just has to hold a few of them college COVID parties in Alabammy or Floriduh.  Those krazy kollege kids seem hell bent on acquiring it.

Maybe offer a case of beer to whoever gets it as an additional incentive.

 

[Ease the sheet.]

If there's a successful vaccine, there will be no need for things like stem cells.

If nobody is getting sick, who will require such treatment?

 

[Wright Way]

Unlike you I have skin in the game and every night when my partner gets home from the hospital and we have dinner and go to bed we wonder if we’re covid positive

Bit narrow minded buddy, we all got skin in the game.

Why you so negative about a potential therapy? Let alone one that did better in its first trial than anything else so far that I can find - feel free to show me something better.

With all due respect to your wife's hard work, whatever they are doing at the hospitals isn't really working is it, else we all, not just you, wouldn't be so concerned about catching the little bug.

 

[dachopper]

Result is getting very close now, a doctor from one of the hospitals involved said he had managed to enroll 30 patients out of the 300 since May 4th. There are 14 other hospitals involved in the trial, so stands to reason that mid July is about right for the critical 30% futility / efficacy review. Fingers crossed !

 

[Miffy]

Bit narrow minded buddy, we all got skin in the game.

Why you so negative about a potential therapy? Let alone one that did better in its first trial than anything else so far that I can find - feel free to show me something better.

With all due respect to your wife's hard work, whatever they are doing at the hospitals isn't really working is it, else we all, not just you, wouldn't be so concerned about catching the little bug.

Read the thread from the beginning - it is an over leveraged pharm scam taking advantage of a global pandemic.

If you follow the initial claims - the duration, the number of times it has been "imminent" - then repeatedly extended BECAUSE SO CLOSE - with no actual data, selective reading of ancillary pre-publication papers? If you don't see it, I guess you don't see it. 

 

[dachopper]

"over leveraged pharm scam"

You are a joke Miffy.

For anyone interested in knowing what they have actually done, their results and product, this is the best clip I found that explains the " scam " as Miffy calls it



It's 5 years old but still relevant,  product C is now approved and sold in Japan, about to be approved as the primary treatment for agvhd  in the USA by September.

These guys know what they are doing. Enough  said - results any day now !!!!!!!!!!!!!!!!!!!

 

[Miffy]

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.  

Your own words my dude - your own words. "Little Aussie company that could" trading on NYSE.

"Primary end point of survival at 30 days, and also at 7 and 14 days along with other measurements. 33% of the way through the trial."

That was in May. 

 

[MR.CLEAN]

judging from the nature of chopper's posts he has been averaging down and is starting to get desperate

 

[Miffy]

judging from the nature of chopper's posts he has been averaging down and is starting to get desperate

Also really trustworthy practice of copying and pasting from somewhere (obvious due to formatting inconsistencies) without ever revealing the context & where it was from; then when pushed, it is some random paper googled that 1) doesn't specific address the challenge at hand 2) prepublication. 

 

[dachopper]

I don't get your points Miffy.. the trial commenced in May, readout is due any day now.

 

[furr_ball]

mid july.......

what exactly is mid July?

imminent.....

what exactly is imminent?

discuss..

 

[dachopper]

mid july.......

what exactly is mid July?

imminent.....

what exactly is imminent?

discuss..

Mid July was 5 days ago, so any random day after that I am expecting some news.

There is no real data on how the trial recruitment has been going apart from the company saying they expected it would take 3 - 4 months to enroll the full 300 patients - which they said in May after treating the first patient.

They need a minimum of 90 patients to have records 30 days after treatment before the DMC will check for futility or efficacy, and we would get some kind of update.

Given we are half way past the 3 - 4 months to full recruitment guess by the company, it's more than likely over 90 have been recruited and now we are waiting until the 30th day follow up of the 90th patient.

Imminent means about to happen

If - tomorrow they get results back showing overwhelming efficacy, the trial will be stopped, the patients recieving placebo will be offered the actual therapy, and the FDA would approve the therapy for use followed by insurers including it on certain schemes.

Nobody can say when exactly, but they are definately in the window for a result update and most likely will be the first update from a stem cell phase 3 trial in the USA for COVID ARDS. 

 

[dfw_sailor]

In other words,  nothing new.  Don't forget in most cases the results are it didn't work,  or didn't work enough.

 

[dachopper]

In other words,  nothing new.  Don't forget in most cases the results are it didn't work,  or didn't work enough.

Most drugs and most cases agreed. The initial results from the EAP were fantastic for this therapy however. 

 

[RobG]

The window of opportunity is closing fast…

Oxford coronavirus vaccine triggers immune response, trial shows

Hopes for a vaccine to address the global spread of coronavirus have been raised after Oxford University’s experimental version was revealed to be safe and to generate a strong immune response in the people who volunteered to help trial it.

Seems it's now in phase 3. Elsewhere it's reported that the first million doses could be ready by the end of September, with priority for healthcare workers. 

 

[IStream]

Let's not get ahead of ourselves. They're going for a 2-dose regimen, which means they'll have to manufacture ~15,000,000,000 doses to put this thing to rest. Yeah, I know, not quite that much: ~70% herd immunity threshold, antivaxers, etc, etc, but the scale of the manufacturing and distribution and dosing and follow-up dosing problem is still in the ten billion range.

Even if they get a million doses out in September, and even if all the other vaccine trials are successful, we're still going to be dealing with this for years. 

 

[dachopper]

Let's not get ahead of ourselves. They're going for a 2-dose regimen, which means they'll have to manufacture ~15,000,000,000 doses to put this thing to rest. Yeah, I know, not quite that much: ~70% herd immunity threshold, antivaxers, etc, etc, but the scale of the manufacturing and distribution and dosing and follow-up dosing problem is still in the ten billion range.

Even if they get a million doses out in September, and even if all the other vaccine trials are successful, we're still going to be dealing with this for years. 

Agreed.... and even if vaccines work, they do have side effects which stop certain people from receiving them, and they are not guaranteed either, 70% effective would be a good result by the end of this year ( if that is even possible ).

On another note, the FDA has scheduled mesoblasts Therapy Ryoncil which is the one they are using for the Covid trial - for it's ADCOM on 13th August. That is where all the specialists/professors / doctors etc from around the US can look at the results and comment to the FDA on concerns or thoughts they may have on how effective it is. It may influence the FDA decision to authorize the Therapy which is scheduled by 30 September 20.

As soon as it is authorized, it will be available for doctors to prescribe for off label use for COVID ARDS should they want to do that.   

Keep an eye on the major US insurance policy's because if they start including coverage for off label use of Ryoncil - they believe it's worth paying for - it ain't cheap!

I think by the end of September - This mesoblast trial should have 100% completion of all primary endpoints plus most of the 60 day endpoints also - if it is not stopped earlier than that.

 

[IStream]

I don't think Ryoncil's gonna move the needle. Any cell-based therapy is necessarily niche. There's just no way to scale production in any reasonable time-frame, not to mention unforgiving cold chain requirements during distribution. 

 

[El Borracho]

Let's not get ahead of ourselves. They're going for a 2-dose regimen, which means they'll have to manufacture ~15,000,000,000 doses to put this thing to rest. Yeah, I know, not quite that much: ~70% herd immunity threshold, antivaxers, etc, etc, but the scale of the manufacturing and distribution and dosing and follow-up dosing problem is still in the ten billion range.

Even if they get a million doses out in September, and even if all the other vaccine trials are successful, we're still going to be dealing with this for years. 

Do you think the world, especially the USA, has lost some "get 'er done" spirit. Look at what happened in WW2: The production of hundreds of complex aircraft within months. Somehow the entire supply chain, from radios to rivets,  was able to be instantly switched on. Seems like today just finding the little bottles for a vaccine would stymie the mighty industrial base. It's going to be sad when the vaccine is ready and waiting but 150,000,000,000 doses are held up for labels to be printed.

 

[MR.CLEAN]

Do you think the world, especially the USA, has lost some "get 'er done" spirit. Look at what happened in WW2: The production of hundreds of complex aircraft within months. Somehow the entire supply chain, from radios to rivets,  was able to be instantly switched on. 

In 5 months the USA still doesn't have nearly enough N95 masks.  Trump and Jared couldn't figure out how to do it.