Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

RegularDoc,

Over the past couple of years the FDA has withheld approval of many products as a hammer to force companies to bring their plants up to snuff.

They will only withhold products that are to be made in that deficient plant.

In essence the FDA's position is you can't handle what you have so why should we give you more.

You can read up on the major drug the FDA is holding back from Sanofi/Regeneron because of Sanofi's manufacturing plant.

http://www.fiercepharma.com/manufacturing/sanofi-s-and-regeneron-s-expected-blockbuster-runs-into-fda-manufacturing-concerns