The new action by Amphastar relating to Dr. Woodcock adds to the circumstantial evidence that Amphastar’s ANDA is unlikely to be approved.
Sadly, it also adds to a large body of evidence that many long-time FDA employees wouldn't see the appearance of conflict of interest if it co-authored a journal article with them. They do the rest of the Agency a grave disservice in the public arena.
MNTA—A little knowledge is a dangerous thing: this pseudo-analyst thinks MNTA’s share price went up because it has Hatch-Waxman 180-day marketing exclusivity for generic Lovenox:
This unexpected conclusion to the race for a generic Lovenox is a boon to Momenta, which has a lucrative profit-sharing arrangement with Novartis that was contingent upon Momenta's securing the 180-day exclusivity period and locking out other competitors.
Someone needs to let this sorry excuse for an analyst know that the H-W 180-day exclusivity period for generic Lovenox expired in Mar 2009.