Replies to post #16725 on Momenta Pharmaceuticals, Inc. (MNTA)

[Double_Bagel]

Momenta Pharmaceuticals, Inc. (MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that Sandoz’s contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter. The Pfizer facility is a key part of the supply chain for the Company’s Glatopa products. Pfizer has indicated that the warning letter does not restrict the production or shipment of the Glatopa 20 mg (glatiramer acetate injection) product that is currently marketed by Sandoz in the United States.

The Glatopa 40 mg ANDA remains under regulatory review. The Company believes the application review could be completed at any time. However, under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product, and Momenta expects that an approval in the first quarter of 2017 is unlikely. Momenta is working with its collaboration partner Sandoz to resolve this matter in order to allow for an ANDA approval as soon as possible.

Any ideas on how long this delay could be? Hopefully, this means that almost everything else is good and MNTA gets approval as soon as this is cleared up.

TEVA is up about 80 cents from its close. I guess they beat Q1 earnings now. They should better their worst case estimate for 2017 now (they had multiple generics in Q1).

Any chances that MNTA can spin this as positive and convey that approval is almost guaranteed after this is cleared up and that it is only a matter of weeks?

I hope so.