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Wednesday, September 28, 2022 12:20:30 PM
The FDA would never say yes on a partial data set IMO...
Now need the DSMB data on the last 500
The review of it
The FDA "lets chat" meeting
Then either continue the trials using an endpoint change, or close the trials with an end point change and file the formal approval request.. or hope the next variant floods the hospitals as they add test cases and add a few 100 more to the original trial?
Me? I think the long haul covid is where a 10 billion dollar Opportunity is now... as it mirrors many other autoimmune diseases like RA, that Bucci has been used for, for 30 years...
The Liver transplant Bucci orphan drug trial is also ready to go to bat... for the same drug. Straight to phase III.....
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