Replies to post #108537 on Biotech Values

[Mpower]

I think that the challenge will come after MNTA announces their FoB partnership in late November/early December.

[rkrw]

You have to file for approval first and there's no FDA guidance on what exactly will be required to do so.

When do you think MNTA might be looking to challenge this?

[DewDiligence]

When do you think MNTA might be looking to challenge [Orencia]?

Hard to say, but MNTA has been talking a lot about mAbs on its recent CC’s. Although Orencia is technically a fusion protein rather than a mAb, it’s sufficiently mAb-like that it could well be MNTA’s lead FoB program.

As was the case with Copaxone, MNTA will probably disclose nothing about a patent challenge on Orencia until its FDA submission has been accepted by the FDA for review. Unlike Copaxone, however, Orencia is regulated by the FDA as a biologic, and hence MNTA’s submission would be made under the newly created regulatory pathway for FoB’s.