Replies to post #10772 on Momenta Pharmaceuticals, Inc. (MNTA)

[rajaram46]

Well I never expected anyone outside of Momenta to get approval for Lovenox either. It will always be an overhang if Momenta does approved for Copaxone in my opinion. Would love to be wrong.

Eventually, over the long-term the value of the company will be driven by FoB and their new drugs.

-R

[DewDiligence]

Do you expect [MYL] to receive approval at all?

I think so… eventually. As a MNTA shareholder, I’ll be content if MNTA has the only FDA-approved generic for a couple of years.

Please bear in mind that MYL’s Copaxone ANDA is 14 months behind MNTA’s in terms of when the ANDA’s were accepted by the FDA for review (Sep 2009 vs Jul 2008).

[jbog]

polly,

The one company that's going the long route (originally but maybe not by the time we're done) is Synthon. They are close to finishing up a worldwide phase III study comparing their generic Copaxone to the original.

Many of their testing sites are completed already. Now if they have good results, would the FDA insist that the others follow or if they have good results and Momenta/Mylan be the same would it be a shoe-in.

IF their results are bad it could mean the same.