Biotech Values

[DewDiligence]

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

That’s right! In the case of Amphastar, there is modest circumstantial evidence that the ANDA will be not approved for the reason mentioned in #msg-33858393.

There is no such clue for the ANDA from Teva, but the fact that the ANDA has been open for six years does make you wonder if Teva has what it takes to fully characterize Lovenox to the FDA’s satisfaction. When the FDA needed help last year to figure out the contamination problem with Chinese heparin, the FDA turned to MNTA, not Teva (#msg-28748329).

MNTA's ANDA is about half the age of TEVA and Amphastar's ANDAs.

The ANDA from NVS/MNTA has been in the FDA’s court for a cumulative total of 34 months, excluding the 10 months from Nov 2007 to Sep 2008 when NVS/MNTA were responding to the FDA’s questions on immunogenicity. 34 months is a long time, of course, but it’s not an insanely long amount of time given the complexity of this first-of-its-kind application.