Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-223

I agree with you. No need to to take the risk of not completing the trial.

I would like nothing more @GA09 than for MSB to complete recruitment for the COVID-19 ARDS trial to the full 300 participants to give them the robust data I am sure they would be seeking so that they can use it to support approvals for both COVID-19 ARDS and ARDS on its own, but unfortunately I think people need to understand the following:

1. The NIH is s a USA Agency / Government Department housed under the Department of Health and Human Services and they are responsible for biomedical and public health research; they are also the ones who forked out approximately $50 m USD public monies to run this trial.

2. Their aim of funding this trial IMO would be to support a trial of a therapeutic treatment for COVID-19 ARDS to see if it can replicate the initial findings of the treatments undertaken at the Mt Sinai Hospital and provide assistance in curbing the death toll in a once in a hundred year pandemic.

3. If at any of the stages outlined in the initial trial design for interim analysis of 30%, 45% or 60% overwhelming efficacy is actually achieved, they will want the trial to cease so that the treatment can be then made available to USA citizens.

MSB will not have any say IMO of whether the trial is stopped early due to overwhelming efficacy - the NIH and the Icahn School of Medicine will make this decision and no consideration will be given to the recent Ryoncil CRL decision by the FDA ... it has no relevance to these trial Sponsors as their goal has nothing to do with aGVHD - just sayin'

If this is what transpires then the FDA IMO will not really have much choice but to approve Remestemcel-L for the use in COVID-19 ARDS even though MSB would want both COVID-19 ARDS and ARDS on its own ... the results will hit the global media channels and the pressure would be on regardless of their perceived hesitations of stem cells; the rest will be history as they say !

I also stand by my previous comments that I believe the 60% recruitment level of participants will be achieved by the end of October, thus giving us two 30 day 'interim analysis' points in the month of November ... just my musings so let's see what happens in the coming month(s) ....

Have a great night MSB'ers

GLTAH