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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST
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To: Jeffry K. Smith who wrote (2677)12/22/2010 3:29:57 PM
From: tuck  Read Replies (1) of 3027
 
Various assays can evaluate immunogenicity with varying degrees of reliability; I'm trying to remember what the FDA required in this instance (or if it was revealed). Likely a rat study. The most reliable is human trials, but given proof of sameness on the other criteria, the FDA did not require that -- and isn't supposed to in the ANDA path to approval. In fact, the FDA said it was for manufacturing control, not safety, to get around just that legal/regulatory issue, which was raised by Sanofi in their suit against the FDA on this matter.

Cheers, Tuck
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