Ann: COVID ARDS Trial Topline 60-Day Results, page-323

Agree that it was a very good post on the best guess we can make of the study sizes in the two sub analysis groups. I also came up with the same numbers on my back of envelope guesstimates last night.

The Dex + RemL 75% reduction is solid on that 'sub study' size of about 80. I don't care what ppl want to be obsessed with it being only a secondary endpoint. It is just an more accurate reflection of the primary endpoint, 30 day vs 60 day mortality rate. I suppose once patients had cascaded down to this level of treatment, there weren't just going to pop them on a ventilator for a couple of days. Mechanical ventilators can extend life for a long time.

So is FDA serious about being data driven and following their EUA guidelines? These kind of numbers will not wash out by being forced to do another larger study size before approval. The biological effect is clear and the product has an excellent safety profile. It sounds like we are back to aGVHD arguments but this time we have an RCT, we have an serous unmet need but more importantly we have an EUA order for any treatments which can show affectiveness against C19. If Novartis had owned this study I would be a lot more confident on an EUA. We have a scenario which is pretty close to that, just a $50M stands in the way. I would love to be privvy to how this is playing behind closed doors between MSB, Novartis and FDA. An approval under EUA could potentially fund the other all cause ARDS trial for Novartis. They should have them incentivised to resourcing their best regulatory, legal and executive FDA contacts on this ASAP.