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genisi

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genisi

Re: DewDiligence post# 2147

Thursday, 03/26/2009 5:55:13 AM

Thursday, March 26, 2009 5:55:13 AM

Post# of 3599
Copaxone was approved as an NDA through 505(b) that is why the FDA accepted Sandoz’s ANDA for review. However, given its complexities, I don't believe the FDA will treat this other than a biologic drug - meaning full clinical trials to demonstrate safety and efficacy will be required. We need not further debate on that, just wait for the anticipated FoB legislation to pass.

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