Biotech Values

[DewDiligence]

MNTA TEVA:

I very much hope your asymmetric outcome turns out to be true as I am long MNTA. However, we have no way of knowing whether or not MNTA is going through the same type of labeling discussions with the FDA, correct?

MNTA’s executives have never said anything about labeling discussions or about having the Lovenox ANDA switched to a 505b2 NDA; to the contrary, Crag Wheeler has insisted all along that the Lovenox review is being conducted under the normal 505j pathway for generic drugs.

For MNTA (unlike Teva), any change in the status of the Lovenox review would easily meet the threshold for materiality; hence, if MNTA does not confirm such a status change on the CC in two days, it’s safe to infer that NVS/MNTA’s Lovenox application is being reviewed as an ANDA.