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Posted On: 04/27/2021 11:47:44 PM
Post# of 153986
OK. Reading your post history you are just saying CYDY didn't originally request 4 doses for CD16, not CD12.
I think NP rushed ahead with CD16 thinking just repeat CD12 with more critical subjects and would get approval. It wasn't until they did additional analysis to see the 14 day mortality that they decided to push again for 4 doses and IV for first. You are critici,ing the failure to change the protocol and fight FDA fast enough, is that it?
I'm sure there is some back and forth with FDA on many things. It's hard when you don't have much leverage with them. I do agree that someone more experienced could probably navigate FDA better. Is it they don't know what they are doing scientifically and clinically, or that they don't know how to play the FDA game? Probably some of both. Hard to judge not knowing all the interactions.
I think NP rushed ahead with CD16 thinking just repeat CD12 with more critical subjects and would get approval. It wasn't until they did additional analysis to see the 14 day mortality that they decided to push again for 4 doses and IV for first. You are critici,ing the failure to change the protocol and fight FDA fast enough, is that it?
I'm sure there is some back and forth with FDA on many things. It's hard when you don't have much leverage with them. I do agree that someone more experienced could probably navigate FDA better. Is it they don't know what they are doing scientifically and clinically, or that they don't know how to play the FDA game? Probably some of both. Hard to judge not knowing all the interactions.
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