Biotech Values

[RockRat]

Agree MNTA stock price reflects no upside from anything.

Although the leader of the executive branch is interested in lower drug prices, that's allegedly been the case for some time. Policy perversity from the FDA is not new wrt its responses to CPs, either. Here's an example that conveys some of my uncertainty about it (check out that url: "slaughter.house.gov sooo appropriate in this case!):

http://www.slaughter.house.gov/index.php?option=com_content&view=article&id=2735:slaughter-applauds-court-ruling-against-fda-on-antibiotics-in-animal-feed&catid=101:2012-press-releases&Itemid=55

I have no idea what the policies are wrt to what the FDA must say when approving a generic that has been the subject of CPs that have already been denied, as in the Copaxone case. I gather the enoxaparin case was different, in that the CP was left in limbo for a good while until the generic was finally approved. This difference is at least partly due to recent legislative changes:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/01/fdas-fourth-annual-report-to-congress-on-505q-citizen-petitions-agency-continues-to-express-concerns.html

So to me, the FDA is still a black box wrt on this stuff.

And does it really matter? Seems to me FDA is forced to require the same testing of all applicants and to inform them what that testing is. At which point said applicants can refer to the appropriate Momenta process patents on Copaxone and copy those, protected by the current interpretation of the safe harbor clause, which, according to the SG, has been sufficiently clarified in this area by the opinion rendered in the Momenta vs Amphastar appeal.

I believe FDA's hands are tied here.

Regards, RockRat