News Focus
News Focus
icon url

pollyvonwog

10/28/12 11:51 AM

#151371 RE: iwfal #151368

Right now much of their substitutible business model is hanging on one legal thread (I.e. if the recent ruling on safe harbor gets upheld it kills >50% of their NPV.



Can you elaborate on this? I don't see this case to be that devastating for their future products. The reason Ampha was even able to get approved to begin with was because the FDA laid out the process when they approved MNTAs ANDA. If MNTA can't get en banc or the supreme court to turn it around, I would also have to imagine MNTA/FDA would approach things differently in the future.