Replies to post #16894 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The word, may, which CW emphasized on the 4Q16 CC, comes directly from the warning letter (near the bottom):

Until these violations are corrected, we may withhold approval of pending drug applications listing your facility [emphasis added].

[biotech_researcher]

Why would they (PFE) wait until the very last day to respond?

[jbog]

The good part is that most if not all the problems come from the SOP, Training and CGMP components of drug manufacturing.

The one section that's tentative and bothersome is why they did not follow their current CGMP policies and responsibilities.

Pfizer is better than this. They'll have to move some teams from the Pfizer brand sites into Mcphearson for awhile.

Nothing shocking.