Saturday, March 06, 2021 2:11:34 PM
I completely agree with your assessment. If the company was going to announce bad news and the severe group did not perform like everyone is indicating, the company would have been smart to just put that in a PR and get it behind us. The truth is, no one really knows how the severe group performed versus SOC. Remember, Nadar indicated that the overall mortality at some point was around 22%, which is pretty low in comparison to other trials that have been published. I am optimistic that the severe data is better then expected and hopefully there is a PR at some point Monday prior to the conference call. Why allocate 90 minutes to Q&A to get grilled about a failure, as far as I can recollect this is the greatest amount of time that has been allocated to Q&A. It is possible that the FDA wanted to see what subset of the trial the drugged worked on and did not feel comfortable with approving for severe due to low sample size, thus the 45 additional OLE and maybe will approve for just severe and await the additional trial data for critical. The fact the severe was not PR'd does not equal failure in my mind, no top line trial data was released.
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