Replies to post #120736 on Biotech Values

[DewDiligence]

…getting actual FDA approval is a lot more important than the patent challenge…

Indeed. FDA approval before the Copaxone patent litigation has run its course will likely result in an immediate settlement, IMO.

[investorgold2002]

agreed. I think FDA approval would come by...question is timing.
The reason i am confident on FDA approval is, FDA has repeatedly , publicly given the lovenox approval as an example when talking about pathway for complex biologics...also, look at MNTA's copaxone patents for characterization both for structural characterization and biological activity assaying..Also, wheeler has repeatedly mentioned they think their ANDA was complete at the submission and they are very happy with feedback with FDA...

I also think they have strong on inequitable conduct even with new higher standard required for proving it.

I think it is important to get approval sooner than later, as i personally think Gilenya and other soon to be released ORAL MS drugs will eventually erode a significant share of Copaxone. You can see that happening already in Gilenya. Real bad thing about Copaxone is , is you have a partner wanting to sell a competing new drug Gilenya...I don't know how much interested they would be selling "not patent protected" generic Copaxone(potentially open to further generic competition) versus growing their marketshare in Gilenya
So yeah, i think timing of launch is key here..sooner the better.