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Wednesday, 03/17/2021 4:51:27 PM

Wednesday, March 17, 2021 4:51:27 PM

Post# of 232932
I just listened to an interview with Mrs Woodcock. She showed a graph where out of 2895 trials for Covid only 5% were powered and randomized enough to pass the minimum requirements. And I understood her saying that trials with 400 arms just not good enough to deliver results.

Being a greenhorn in pharma I can not understand why we had our trial CD10 with 295 arms and CD12 with 395 arms when 400 is for FDA a "joke" (not powered enough)? I criticized many times that Nader isn't focused but run all and nothing at the same time. Watching this interview today gave me the idea if we would have CD10 with 800 to 1000 arms we would be today approved. And the same with CD12.

If I understood the messages from FDA in the correct way then I conclude that also greenhorns designed these trials. They should have known that 295 and 395 aren't enough. Focus money, focus man- and brainpower and get it done.

Now the question is, will be additional 140 arms in CD16 enough or do we run another joke demonstration! Who knows it?
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