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Re: DewDiligence post# 212019

Friday, 06/23/2017 9:03:05 AM

Friday, June 23, 2017 9:03:05 AM

Post# of 257268
Leaving the mfg. facility aside, FDA should(/must) have completed rest of the mCopaxone 40 mg review & given a CRL to Momenta much earlier during the 30 month stay (when MNTA was expecting). That would have given $MNTA a chance to explore other fill/finish supplier & launch a lot early than 2018.

This mess created by FDA will cost millions to Momenta. Surprisingly, there's no apparent recourse.

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