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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Felix B who wrote (1959)	10/30/2016 12:14:57 PM
From: Miljenko Zuanic	Respond to of 3559

There in no time frame definition for delay after CRL. It can be few months, it can be permanently. Usually it take 3 month to respond (and resolve) to FDA manufacturing (CMC) concerns. Unless problems are much deeper and need more time (corrective action plans + completed tasks before FDA will do re-inspection). In that case they will need 6-12 months. Very DISTURBING events in Sanofi collaboration, for sure.