Biotech Values

[DewDiligence]

MNTA: Is management really that in the dark when it comes to final FDA responses?

With respect to the timing of an FDA ruling on Lovenox, I think NVS/MNTA’s only clue worth talking about is the nature of the current discussions with the FDA. This is not unique to the Lovenox ANDA, but rather is the norm for ANDA reviews.

My primary fear is FDA drags its feet and becomes handicapped because of politics.

Well, to the extent that the FDA is gun shy about acting, politicians such as Chris Dodd—acting head of Senate committee that oversees the FDA—are doing their best to give the FDA some political cover: #msg-38566305.

If this doesn’t induce the FDA to act on the Lovenox ANDA by the end of 2009, I think NVS will file a lawsuit to compel the FDA to act, just as NVS did in the Omnitrope case.