Biotech Values

[biomaven0]

what kind of REMS will be used do you think?

As I understand it, VVUS proposed a REMS that would completely restrict the drug from childbearing-age women, and the FDA had concerns that those women would then just use the generic combo instead.

So I would anticipate at most strict it would be something along the lines of Accutane, although obviously that drug is better than an order of magnitude more teratogenic. (Note there are still some pregnancies on Accutane, but I think that has a lot to do with the very young target population there). Accutane had a patient registry and 30-day script limits.

I'm of the view that a REMS is actually a plus because it will dramatically reduce doctors using the generic combo in women.

Peter