if manufacturing is the only issue- another trial pre-approval won’t address it... as the FDA doesn’t even know where to start in designing a trial that would solve their dilemma.
so all this is really hanging on imo is efficacy... safety is not an issue.
note that the only question to the panel of experts is on efficacy... that isn’t by accident.
if we see a majority yes vote tonight, we can safely assume we will get approval with strings attached ... and not a CRL.... and the market will like that very much.
FDA ODAC Meeting Material discussion analysis, page-311
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