ITMN DNDN: Right or wrong, the FDA is at least being consistent in not approving pirfenidone on the first review cycle. All told, I would rate the quality of the pirfenidone NDA on a par with DNDN’s original Provenge BLA, where the FDA ended up requesting a new trial. A key difference: DNDN already had Plan B (the IMPACT study) in effect at the time of the FDA non-approval in 2007, but ITMN has no such backup plan in progress.
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