Momenta Pharmaceuticals, Inc. (MNTA)

[Boing x 2]

First that I heard of this one.

http://www.biopharminternational.com/momenta-receives-warning-letter-generic-copaxone


"Meanwhile, on Feb. 16, 2017, a day before Momenta formally recognized the warning letter, Pfizer CentreOne announced it has expanded its fill/finish capabilities to its Kalamazoo, MI site. The site will now handle sterile injectables.
Source: Momenta"


This brings up a lot of interesting question. Does Pfizer owe us an obligation to get the 40mg Glatopa approved and manufactured at the MI plant if they can’t get approval, at the Kansas plant, for months yet. Apparently the MI plant has the ok for production of sterile injectables..

How hard would it be for Pfizer to tell the FDA that the 40mg Glatopa would be manufactured there while they work out the Kansas problems.

Note the PR.

https://www.pfizercentreone.com/news/contract-manufacturer-pfizer-centreone-expands-fill-finish-services-its-kalamazoo-michigan

Why did I have to scour the net to find out about this blurb? Why is Momenta not pushing hard on Sandoz and Pfizer to do this.

Pfizer is costing us all big bucks and this should be a no brainer to cut our losses since they have a new plant with the capacity and should give us priority so we can get the FDA approval.
Not sure if the FDA could hold us hostage on approval because of Pfizers problems if they tell them they will manufacture at the new plant.

How about this as an option? Manufacture at the new plant. Momenta is aware of this MI plant based on the PR. I know Sandoz and Pfizer control but, they should not control to the detriment of our FDA approval by not mfg. at a new plant.

It would seem that after 18 days that is what we should be hearing is going to be being done or if not why not. Days count big time on all our losses. It would take one day to let the FDA know they are switching to the approved plant. That would take us out of the twilight zone here.

There might be reasons why they can’t, but. no one is telling us why not.


Boing X 2