Tuesday, July 30, 2013 4:31:29 PM
The only thing I would say is that the FDA accepted MNTA's application as an ANDA and has not made any indication that they don't intend to pursue it as an ANDA
I fully agree with you. My question is that one of the main reasons to partner with Momenta is supposedly their ability to decipher drugs so they can be presented to the FDA. If the FDA will choke on the data sets with every application and take 5 or 6 years to approve each drug they won't be of much value going forward.
With Copaxone it really doesn't matter much because the patents are still applicable.
I recall that Momenta's payment with Baxter is sweetened in regards to time and or trials.
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