IJ -
I'm saying I have no idea what the FDA will do. The absence of any test for efficacy will certainly make them uncomfortable. As I see it, they could resolve this discomfit in some different ways:
1. Make MNTA do some clinical trials - this would be unprecendented for a generic, so I really don't see this as likely. (Same logic as I use to support my belief that a non-substitutable t-enox is a non-starter).
2. Be extra-demanding on the characterization side - but this is hard given Copaxone is really a class of molecules rather than a specific molecule.
3. Turn MNTA down.
So bottom line I am on the pessimistic side here. But given the rewards for success, the expected value of even a 20% shot at approval is significant and may not be reflected in MNTA's current stock price.
Given I personally think a t-enox approval is likely, with timing still uncertain but my guess would be well within the next year, my current strategy is to stay on the sidelines and see if there will be a buying opportunity if that comes to pass and the market overreacts. Sure I might miss a nice move (e.g. if MNTA find a partner for a another project or Teva announces some major delay), but there are plenty of other fish in the biotech sea.
Peter
AI
