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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