Biotech Values

[DewDiligence]

MNTA – Legal requirement for the FDA to act on the Lovenox ANDA:

or.........never come.

Actually, at some point the FDA does have to act on the Lovenox ANDA—it can’t be held in limbo indefinitely.

A precedent was established in the Sandoz v. FDA case by the U.S. District Court for the District of Columbia: #msg-10688700. The Court ordered the FDA to take action on Sandoz’s Omnitrope application, and Omnitrope was approved by the FDA about six weeks later.

Incidentally, MNTA’s shares rose 7% on the day the FDA approved Omnitrope in May 2006. From #msg-11370846:

MNTA – Omnitrope fallout: Based on today’s trading only, the largest benefactor of the FDA’s decision appears to be MNTA, up 7%.

I thought MNTA would be up even more on today’s news because the FDA’s approval of Omnitrope would seem to lessen the doubt surrounding the generic Lovenox application submitted by MNTA and NVS. Even though the generic Lovenox application is an ANDA rather than a 505b2 submission, the FDA may be worried about getting sued again if it doesn’t behave and puts up more silly excuses for letting an application languish.