Replies to post #17110 on Momenta Pharmaceuticals, Inc. (MNTA)

[t57]

I think that the 20 mg line and safety concern for 40mgs is mute.
I think it's FDA using all it's muscle to get Pfizer to bring the plant into compliance.
MNTA is just an unfortunate victim of the enforcement

[jbog]

If same plant but different production line for 20 ml copaxone...is allowed to continue, a few questions

1. Plant violations affect new approvals only - setting up new production lines?
2. I presume that Pfizer would set up a new line for the 40ml and have it inspected by FDA - could this happen if the plant had "other general" violations?
3. I would stop the 20ml production line and convert it to 40ml and go after the 80% of the market if possible

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It has nothing to do with 'a line'. It has everything to do with new products and extensions of products.

Out of the many infractions that PFE was sited for, the majority of the infractions had to do with the policy of the complete operation. The FDA actually went as far as I've ever witnessed (except Ben Venue) and said that because Hospiria has been sited for the same infractions at many plants, maybe the should make dog food instead of drugs.