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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: stockdoc77 who wrote (49574)	1/22/2019 12:01:42 PM
From: KeeptheFaith	1 Recommendation Recommended By dorightbythem Read Replies (2) \| Respond to of 63320

<<In some sense, 132 has derisked significantly as the drug itself passed muster with FDA for approval.>> Stockdoc, I have read this from several folks. The silver lining is 132 is derisked because the FDA concurred it works (just can't be manufactured appropriately yet thus the CRL). My question: How do we know the FDA reviewed the safety profile and efficacy of 132 and approved that component of the BLA? Yes, Pehl said the CRL was "NOT about the drug itself". But does that mean it 'passed' the FDA review? Or did the FDA not review the safety/efficacy of 132 yet since it didn't get past the 'CMC issues review phase' first? Asked differently, if the FDA finds a reason for rejection, do they stop reviewing the rest of the application and possibly never got to the safety/efficacy review for 132? My thought is that multiple FDA folks are involved, and they focus on various different aspects of the BLA which is their area of specialty, and it is a simultaneous review of the various facets....and the CRL would have included any/all issues that keep the drug from market......but I look to others for the answer. -KTF