Replies to post #72985 on Biotech Values

[tinkershaw]

MNTA - Just been pondering the ANDA process. It is my understanding that TEVA and Amphastar filed their ANDAs over 6 years ago. Six years!!!

Has anything changed from here to there on their ANDA's? Six years is more then enough time for even the Japanese lettuce inspection agency to let in American lettuce off the dock during a trade war.

One cannot really read too much into anything the FDA does. However, in 6 years there cannot be anything in those ANDAs that the FDA does not already know about, and that the FDA is not concerned enough about to not move the ANDAs forward.

MNTA's ANDA is about half the age of TEVA and Ampahstar's ANDAs. Does it mean anything that the FDA has done nothing with the competition ANDA's in 6 years? Does it mean anything that TEVA and Amphastar have taken no legal action to get the FDA moving on these applications?

Probably not, but I gotta think it means something in regard to the quality of the ANDAs that were submitted. CYA only goes so far.

Tinker

[DewDiligence]

MNTA 2009-2010 Possible/Probable News Flow

[Updated for release of M118 phase-2 data.]


2H09: FDA action on Lovenox ANDA. (ANDA’s do not have formal timelines, and hence an FDA decision could come at any time.) If approved, generic Lovenox can be launched immediately because all patent-related issues have been resolved.

2H09: Partnership deal for M118. (This partnership could not be consummated until MNTA reported the top-line M118 data from the phase-2 EMINENCE study, which occurred on 6/29/09.)

2H09 (following partnership deal): Start one or more phase-2b trials for M118.

2009-2010: IND filing for M402, MNTA’s proprietary heparin-based cancer drug.

2009-2010: Possible announcements of new FoB partnerships or progress on existing FoB partnership with NVS.

2010-2011: FDA action on Copaxone ANDA. Although the FDA is barred from granting final approval of the ANDA before the statutory 30-month stay expires in Feb 2011, the FDA is allowed to take other actions during this period including tentative approval, non-approval, or a request for more information.