Momenta Pharmaceuticals, Inc. (MNTA)

[Boing x 2]

Here is what I think,


The FDA, IMHO, could have a major big problem if it can be shown they are withholding Glatopa 40Mg approval due to Pfizer not complying at their manufacturing plant.

Here is what should happen.if they have no issues on the drug for approval but only the production line, the FDA should inform Momenta that the drug is approved but not for the current
Pfizer line. That upon a new approved production line or correction of the current line they will give final approval.

One can’t hold Momenta hostage for someone else's mistakes. They can make us have an approved line and they should give approval subject to an approved line but not hold up approval of the drug subject to an acceptable line. Time is of the essence for Momenta having first approval.

This is a hugh potential monetary damage suit for Momenta if they hold us hostage over a production line, that we have no control over, when the drug has no further approval issues. Should they then give anyone else approval prior to us it would be game on.

I don’t think they could defend themselves if there were no issues on the drug and only on the approval of the production line. I even feel a jury would feel that they could have given approval subject to an acceptable line.

Boing X 2