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News Focus
Replies to #62627 on Biotech Values
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DewDiligence

05/29/08 4:15 PM

#63020 RE: DewDiligence #62627

MNTA 2008-2009 News Flow

[Updated entry for Copaxone ANDA filing.]

3Q08:
Resubmit Lovenox ANDA with immunogenicity info requested by FDA.

2H08:
M118 phase-2a data in stable angina presented at medical conference.

2H08:
Start M118 phase-2b trial in PCI.

4Q08/1Q09:
FDA action on Lovenox ANDA (assuming resubmission of ANDA in 3Q08).

2H08:
Submit ANDA for generic Copaxone (no formal guidance from MNTA, but 2008 seems likely: #msg-29627289).

2H08/1H09:
Ink partnership deal for M118.

2H08/1H09:
Announcements re FoB program.