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Biotech / Medical : Momenta Pharmaceuticals Inc.
MNTA 52.480.0%Oct 2 5:00 PM EST
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To: semi_infinite who wrote (2973)6/25/2014 4:23:55 PM
From: DewDiligence_on_SI   of 3027
 
What's your opinion with regards to the influence of TEVA's legal maneuvers on FDA copaxone review? Seems that to me the FDA should have had plenty of time to evaluate the Sandoz/Momenta filing and that it should have been done by now if the data is adequate.
Teva seems to have succeeded at delaying the FDA decision to some degree by introducing the issue of gene expression. According to Court documents in the public domain, the FDA requested gene-expression data from MNTA about 2 months ago, and this is presumably the last item holding up approval.

Background: siliconinvestor.com ;
siliconinvestor.com

Regards, Dew
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