Replies to post #17030 on Momenta Pharmaceuticals, Inc. (MNTA)

[rwwine]

If that's truly the case, then MNTA had no right providing guidance that 40 mg was expected in Q1-2017. Speaking of which, have they updated publicly when they now expect FDA approval? All I think I've seen is that they are engaged with Sandoz their partner. TIA

[jbog]

I'm sure they were aware of the investigator report (483's).

The trouble began when the FDA felt that Pfizer wasn't correcting the problems either quick enough or to the FDA's satisfaction, that's why the warning letter was issued.

If the FDA felt the problems were being addressed properly they never would have issued the warning letter and there would be no problem.

Pfizer has a lot of explaining to do because they were previously cited for some of the exact same problems years ago and if they did rectify them years ago why are the problems back.

I never believed that Sandoz/ Momenta was going to launch 'at-risk' in February which was the general board consensus, but I did think they'd launch this year. Maybe not after this crap.