Analysis of the EAP, page-71

No, I'm not @LeftYahoo but I've been posting on this subject a bit lately. Fairly directly about study design and the importance the FDA is placing on it.

• On 24 April 2020 in the ASX announcement of the initial 12 patient study results

83% survival in COVID-19 patients with moderate/severe Acute Respiratory Distress Syndrome treated in new york with Mesoblast’s cell therapy remestemcel-L

There is this comment by Mesoblast Chief Medical Officer Dr Fred Grossman;

"We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS.”

• In the ASX release on 30 April 2020;

Phase 2/3 randomized controlled trial of remestemcel-L in 300 patients with COVID-19 Acute Respiratory Distress Syndrome begins enrolment
Is this statement;

The FDA has given specific guidance on key aspects of the trial.

One of my earlier posts regarding the trial design was on 12 May, Post #: 44583861 reproduced below, the link immediately below was a recently recently released FDA guidance on what they wanted in COVID-19 trial design, released 10 days after the trial design for the Icahn/Mesoblast trial went live on ClinicalTrials.gov.

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COVID-19: Developing Drugs and Biological Products for Treatment or Prevention
Guidance for Industry
11 May 2020

Really interesting, the people whom the current trial is about are clearly defined as Critical COVID-19 on page 14
If someone with enough expertise were to take the time I suspect the overall trial design considerations on ClinicalTrials.gov would be exceptionally close to that defined in the document. With my level of layman interest I can only surmise

Of special interest to me is this paragraph on page 12, because it encompasses the Primary Measure of the trial underway, all causes mortality;



The Icahn School of Medicine at Mount Sinai and Mesoblast seem to have taken the bull by the horns in the trial design. Perhaps because they have a fairly clear idea this may work based on the initial 12 patient study.