MNTA:
A few quotes from the CC (transcript on seekingalpha):
Generic Lovenox
The M-Enoxaparin ANDA continues to be under reviewed [appropriate slip in transcription, lol] by the FDA, and we remain cautiously optimistic that 2009 approval is possible. Should an approval be granted, we have large supply available and we and Sandoz intend to launch as soon as possible following the FDA’s decision.
At this point our heparin suppliers and API manufacturer have been inspected with no significant issues identified to us. However, we have not yet received the final inspection reports and the questions could be asked at any time.
In short, we remain confident in the approvability of M-Enoxaparin and we believe the FDA has all the major elements it needs to approve the ANDA. While we believe it is possible to receive an approval in 2009, there is no statutory timetable for an FDA decision, so the ultimate timing of the decision remains uncertain.
M118
As we’ve discussed in the past, we are actively seeking a collaboration partner to finance and support further clinical development of M118. We are continuing discussions with multiple potential partners, but do not anticipate entering into a partnership before year-end. [This quarter doesn't look good for a deal. Perhaps Q1?]
