MSB (ASX) Ann: DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial

Originally posted by LearningEachDay: ↑

"just because a few people are dying"

You may have a few relevant points in your post, but this incredibly insensitive and inaccurate statement left me too angry to seriously consider anything you had to say...

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Originally posted by col69: ↑

I can't see the FDA throwing best practice out the window just because a few people are dying.

WOW .... so almost 9,000 people in the last seven days in the USA alone have died and you say "because a few people are dying" ?

As for FDA best practice and I will even throw integrity into the mix for good measure - that went out the window long ago under this president IMO ... here's just one recent example .... there are a number of others but I won't bore everyone with them as they have been posted before

https://www.fiercepharma.com/pharma...ms-but-experts-say-correction-wasn-t-accurate

FDA chief Hahn walks back plasma claims

As others have said, IF Remestemcel-L is working at a better rate than current therapies (the DSMB know whether this is true or not from the two interim analysis already conducted) and saving lives then regardless of whether it shows 'overwhelming' efficacy it is probably morally irresponsible for the DSMB to not have discussions with the FDA and NIH to enable them to look into issuing an EUA ?

There are 'options' available to government bodies during this time to circumvent the 'norm' so again IMO the DSMB would be able to have discussions with NIH/FDA using one or a combination of Acts, Legislation etc - for example;

https://www.federalregister.gov/doc...-preparedness-act-for-medical-countermeasures

https://www.whitehouse.gov/presiden...-novel-coronavirus-disease-covid-19-outbreak/

I would also add that the trial was funded by the NIH to ascertain the effectiveness of Remestemcel-L in the treatment of COVID-19 ARDS during a global pandemic .... This is important for people to remember as ARDS in general at this time is not their purview and while MSB would like to recruit the entire 300 participants to obtain robust data to support a BLA for ARDS in general at a later stage, people need to remember that is not why the NIH funded the trial in the first place.... it would be a nice to have for MSB but isn't a priority for the NIH at this time - just sayin'

GLTAH

Expand

Originally posted by col69: ↑

I can't see the FDA throwing best practice out the window just because a few people are dying.

WOW .... so almost 9,000 people in the last seven days in the USA alone have died and you say "because a few people are dying" ?

As for FDA best practice and I will even throw integrity into the mix for good measure - that went out the window long ago under this president IMO ... here's just one recent example .... there are a number of others but I won't bore everyone with them as they have been posted before

https://www.fiercepharma.com/pharma...ms-but-experts-say-correction-wasn-t-accurate

FDA chief Hahn walks back plasma claims

As others have said, IF Remestemcel-L is working at a better rate than current therapies (the DSMB know whether this is true or not from the two interim analysis already conducted) and saving lives then regardless of whether it shows 'overwhelming' efficacy it is probably morally irresponsible for the DSMB to not have discussions with the FDA and NIH to enable them to look into issuing an EUA ?

There are 'options' available to government bodies during this time to circumvent the 'norm' so again IMO the DSMB would be able to have discussions with NIH/FDA using one or a combination of Acts, Legislation etc - for example;

https://www.federalregister.gov/doc...-preparedness-act-for-medical-countermeasures

https://www.whitehouse.gov/presiden...-novel-coronavirus-disease-covid-19-outbreak/

I would also add that the trial was funded by the NIH to ascertain the effectiveness of Remestemcel-L in the treatment of COVID-19 ARDS during a global pandemic .... This is important for people to remember as ARDS in general at this time is not their purview and while MSB would like to recruit the entire 300 participants to obtain robust data to support a BLA for ARDS in general at a later stage, people need to remember that is not why the NIH funded the trial in the first place.... it would be a nice to have for MSB but isn't a priority for the NIH at this time - just sayin'

GLTAH

Expand

The science here for overwhelming efficacy is not that it must be achieved, it's to rule out the fact that sometimes you get lucky with treatments that are not effective.

There are so many confounding factors that all add together to make it unreasonable to claim it works based on small numbers - different hospitals, different standards of care, different population genetics, ........ Just look at the death rate that was used in the initial emergency use and ask yourself if that is an accurate comparison to make now...

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