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Replies to #63020 on Biotech Values
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DewDiligence

07/11/08 7:21 AM

#64132 RE: DewDiligence #63020

MNTA 2008-2009 News Flow

[Updated entry for Copaxone ANDA.]


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

2H08:
M118 phase-2a data in stable angina presented at medical conference (probably ASH in Dec 2008).

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

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

2H08/1H09:
Partnership deal for M118.

2H08/1H09:
Announcements re FoB program with Sandoz.

2009:
Possible FDA decision on Copaxone ANDA (no formal review schedule).


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