Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Now you are starting to sound like a cockeyed optimist!
1. FDA's latest CP released end of March 2011, says it is premature to talk about any criteria for determining sameness for COPAXONE.

As previously noted, the FDA had a statutory requirement to reply to Peptimmune on or before April 1, so this is not a good clue regardng the status of MNTA’s Copaxone ANDA.

2. Company has said in it's March 2011 CC, that there is much bigger backlog compared to backlog that used to persist back when ANDA for lovenox was being reviewed.

That’s not exactly what was said, but the salient point is that OGD’s backlog of applications mainly affects the timing of an ANDA review on the front end—i.e. in the time it take to accept the application for review and to provide initial feedback to the applicant. Once an application is past this stage—which MNTA’s ANDA is—the backlog of other applications at OGD is not directly relevant to the speed of the review.

It took many (I guess 5-6 years) to get generic LOVENOX approved after ANDA filing. Copaxone ANDA was filed in late 2007, so any guesses would be after >5 years considering bigger backlog and also considering more complexity for determining sameness.

Lovenox was the first ANDA to be approved for a complex-mixture drug, so it’s reasonable to assume that the novelty caused the Lovenox review to take longer than it otherwise would have. As noted above, the backlog of applications is not directly relevant at the current stage of the Copaxone review.

3. Finally incentive plan, the March 2015 date.

Do MNTA’s restricted-stock awards affect the speed of the FDA review?