Replies to post #16368 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The only significance of Jan 28 is that it marks the expiration of TEVA's 3-year Hatch-Waxman marketing exclusivity for 40mg Copaxone. If FDA approves NVS/MNTA 40mg-Copaxone before Jan 28, it will be a tentative approval that converts to a final approval when TEVA's exclusivity expires.

Even with FDA approval, NVS/MNTA won't launch 40 mg Copaxone until they get a favorable ruling from the District Court on the patent litigation. So, as a practical matter, it doesn't make much difference whether FDA approval comes before or after Jan 28.