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DewDiligence

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DewDiligence

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Re: jbog post# 86120

Tuesday, 11/10/2009 10:18:28 PM

Tuesday, November 10, 2009 10:18:28 PM

Post# of 257262

I've seen situations of changing a $5000 mixer in a bioreactor cost millions of dollars and a couple of years.

True; however, Copaxone isn’t a biologic, so one would think that changes to the delivery mechanism filed under an sNDA ought not to be as problematic for the FDA as changes to a protein drug.


“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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