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Re: tripmcneely post# 33153

Wednesday, 09/28/2022 12:20:30 PM

Wednesday, September 28, 2022 12:20:30 PM

Post# of 36590
If I was the FDA, I would do what the FDA said to do. Ask for a meeting and, ask for the next 500 person data set...

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.....