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DewDiligence

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DewDiligence

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Re: dewophile post# 92935

Monday, 03/22/2010 3:29:34 PM

Monday, March 22, 2010 3:29:34 PM

Post# of 252714
MNTA:

…characterizing a mix of polypeptides is easier than sugars

Absolutely correct. Because it’s 100% synthetic and has no biologically sourced API, Copaxone is easier than Lovenox to reverse engineer to the lot-to-lot tolerance of the branded product.

If the FDA approves generic Lovenox via the 505j (ANDA) pathway, generic Copaxone ought to be no problem for MNTA, IMO.


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

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