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rantna 1. thx for that link. If

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Whalatane   Wednesday, 09/23/20 04:24:28 PM
Re: ratna1 post# 22365
Post # of 27773 
rantna 1. thx for that link. If they approve based on the limited data from 21 patients on the drug vs control of another 30 ... all at the same Medical center ...it will still be controversial .

Quote:
Susan Ellenberg, a former FDA reviewer and a biostatistician at the University of Pennsylvania Perelman School of Medicine, said an EUA could be warranted on such limited data, but only if the evidence was overwhelming.



Thats why we need the Interim 2 update ...and the final results .

Bottom line we are flying in the dark currently re double blinded placebo controlled data .
IMHO the Interim 2 update is slow or delayed .
The optimist in me would speculate that the DMC has looked at enough unblinded data by now ...to involve the FDA ...either to expedite approval or to at least support the EUA authorization.

As an aside ....Dr Lavin is the key statistician for NeuroRx ...widely known and respected. The MD's selected for the DMC for this small US based IV trial are certainly qualified enough for what they need to do . If we weren't in an election year they probably wouldn't be questioned

Kiwi

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