Wednesday, February 01, 2023 6:59:44 PM
I think about those things as well. Why all of a sudden stop at 712? I think that was answered in a round about way.
Why the holdup on running the information to the DSMB and FDA, IF it was ever determined that the 712 tested patients MAY be enough?
Where was/why the hangup between unblinding the first set of data (and scrubbing the rest of it), until getting the next steps to push forward?
So, I find it not AT ALL surprising when I see the news that the status will change May 11th, and that HHS (another gov't entity) controls the say-so on when EUA approvals through the FDA will end.
Yes, I blame Revive for being a poor company and not necessarily having the full wherewithal for pushing their trials more aggressively. But a much higher percentage of that blame (in my mind) is bound up with red tape.
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