The FDA staff citing its sole use of MNTA for its "expertise" during the heparin crisis strikes me as a fairly bullish sign for MNTA. If FDA staff views MNTA as having expertise, I don't think it's unreasonable to think that MNTA's generic Lovenox is likely being viewed in a better light by the FDA compared to the competition.
That’s why the numbers in the and fifth and sixth rows of the table in #msg-46038154 are small :- )
Actually, the FDA employed parties other than MNTA to solve the contaminated-heparin crisis: namely, an MIT team led by Professor Ram Sasisekharan: #msg-28748329. Of course, Sasisekharan happens to be a founder and director of MNTA (#msg-42166392) :- )
(MNTA TEVA): WPI appears to have dismissed any hope of Amphastar’s obtaining FDA approval for generic Lovenox. Here is what WPI’s CEO, Paul Bisaro, said about Lovenox on today’s CC in reply to a question by Cowen’s Ken Cacciatore:
Regarding Lovenox, Ken, I don’t really have enough insight to give you any valuable read on Lovenox. As you know our partner, Amphastar is the one who deals directly with the agency and we don’t really participate in those conversations, so we don’t have the sort of direct hands-on knowledge. I think others like Momenta, Teva have probably more direct knowledge.