Replies to post #11936 on Momenta Pharmaceuticals, Inc. (MNTA)

[linhdtu]

It's not a fair comparison and an incomplete assessment of the situation.

Opinion: Mnta does have a technical advantage. I do believe so otherwise why bother.

Fact: Ampha's a-enox approval is not proof of ability but a quirk of the american legal system.At the time there was another competitor I can't remember (a partner of Teva I believe) but they did not choose to go the same way as Ampha to get approval.

Fact: FDA biologics guidance and pathway is still not firm.Bit clearer now than 2 yrs ago but still. Hence mnta is handicapped by this lack of clearance.

Perhaps you could do some more diligence into Ampha's enox approval history(even with their total lack of technical knowledge) and that will shed some light into the current process of biologics generics pathway for approval by the FDA.