Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

Double Bagel,

Sadly we don't know enough info to predict a timetable to finish the approval process.

Normally the FDA manufacturing inspection is the last step of the process and I wouldn't see why this wouldn't be anything different.


They stated two things that are of interest. First, if it is a stateside Pfizer facility I wouldn't expect a long delay. If it is an Pfizer facility that they acquired in the Hospira deal (which I would suspect) it could take forever.

Why Pfizer didn't burn every Hospira facility to the ground I'll never understand.


Secondly, they mentioned it's a fill/finish facility. That means the API is ok so it's combining it with a solution, putting in a vial, putting a top on it and then inserting it in a box. Seems pretty easy, so I'd suspect the problem would center around sterility. This isn't an parental drug so the sterility is somewhat relaxed.

The next biggest concern would have to center around cross contamination, either in the storage or finished areas.

How long could it take? Minimum 3 mos maximum would be another F/F facility which would be about a year.