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Re: DewDiligence post# 111138

Tuesday, 12/21/2010 1:54:42 PM

Tuesday, December 21, 2010 1:54:42 PM

Post# of 257579
The authors of the Goldman Sachs report on MNTA appear to be junior analysts who have succumbed to rookie mistakes. For instance, the report includes this misstatement that experienced biotech analysts would be unlikely to make:

We believe a tentative FDA approval [for generic Copaxone] is very unlikely before the litigation outcome is known, as the agency has little incentive to act on applications that are not actionable.

Actually, NVS/MNTA’s Copaxone ANDA becomes actionable in about three weeks, when the Hatch-Waxman 30-month stay expires. From that point on, the FDA can issue a final approval for the ANDA, not just a tentative approval.

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