Replies to post #212019 on Biotech Values

[alternatepatel]

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.

[DewDiligence]

FDA approves PFE’s Epogen/Procrit FoB, Retacrit:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607703.htm

The third time is the charm. FDA rejected this 351(k) application in 2017 (#msg-132420191) and 2015 (#msg-118040117).