Is it though?I sshould know better than to preach pragmatism on this forum, but, what do you think a trial size history for pharma would be.
If I was a lawyer I'd definitely be asking why my client has to have large trials and MSB gets to say ignore the old ones and look at the 55 patient trial.
MSBs job is to explain why it's okay, say for instance that safety is not a concern and so efficacy doesn't need as big a dataset?
Fingers crossed for tonight though.
Ryoncil: ODAC/FDA Meeting Discussion, page-22
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