(Total Views: 441)
Posted On: 11/03/2018 10:06:32 AM
Post# of 72446
I agree with you TPB
No need for PIII in this case and if FDA will suggest, what would be a control arm of the trial???
Placebo again ???
Or maybe larger , more powerful PII , sort of confirmation trial
Years of experience in clinical trials tells me...NO PIII will be required !!!!!
Number of drugs approved for rare conditions based on small ,much less powered PII RCT( Randomised Clinical Trials) in the history of FDA
IMO
I think, very good stuff is coming our way!!! VERY GOOD !!!
Cheers to all faithful longs
No need for PIII in this case and if FDA will suggest, what would be a control arm of the trial???
Placebo again ???
Or maybe larger , more powerful PII , sort of confirmation trial
Years of experience in clinical trials tells me...NO PIII will be required !!!!!
Number of drugs approved for rare conditions based on small ,much less powered PII RCT( Randomised Clinical Trials) in the history of FDA
IMO
I think, very good stuff is coming our way!!! VERY GOOD !!!
Cheers to all faithful longs
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