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DewDiligence

03/27/09 3:45 AM

#2157 RE: genisi #2155

Do you agree to the safety and efficacy part?

No—I think generic Copaxone will have to show safety but not efficacy.

Moreover, the FDA will not (IMO) regulate Copaxone as a biologic. By this I mean that a generic version of Copaxone will eventually be approved even if all attempts by Congress to enact FoB legislation were to fail.