Replies to post #5963 on Momenta Pharmaceuticals, Inc. (MNTA)

[GrthzGd]

Just searched for the Amphastar complaint (was it a citizens' petition?) in Dew's Readmefirst. Couldn't find it either. Interesting point; would like to study the issue further.

[DewDiligence]

So isn't it at least theoretically possible that the FDA approved their enox on the basis of a "grandfathering" or rolling back to previous guidelines that were in place when their application was first evaluated?

No, we absolutely know this is not what happened by reading the information on the FDA’s own webpage at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220018.htm . Regards, Dew