Hi @RatfinkBearing in mind that the trial and its composition...

Hi @Ratfink

Bearing in mind that the trial and its composition had (I understand) precedent and had been devised in consultation with the FDA. I believe comparing it to the ARDS trial and the variables of when it was given, to whom and what had they been given, suggests to me a correlation between the two trials may be a stretch.
Point 2, I believe having listened to the ODAC meeting and discussing it with better others who have a better understanding than me, I felt that Silvu had a robust response to how they measure potency. MOA they were learning about but as others point out, there are approved drugs that have been approved for years and still the MOA is not fully understood.

If you take point 1 under the heading of it was not a gold standard phase 3 trial and your 2nd point then I agree you have accurately assessed their reasons and how my reply could have been better thank you.
regards
Yelrom

Ps
All the points you rightly raise from the briefing notes issued by the FDA for the ODAC meeting (@Praetorian2011 has helpfully posted the link above) were discussed and taken into consideration at that meeting and the vote was pretty clear that they did not consider it a reason to say no.
Their subsequent decision ignored that overwhelming recommendation which suggests that their decision was already made and they had hoped that their briefing notes would be supported by that committee.