"in ARNA's case, a REMS was not part of their NDA resubmission, after their 2010 CRL, and to my knowledge has not been formulated yet by the company. As the article I cited states:
Sponsor companies should begin considering the possibility of a REMS requirement early in the development process. The risk threshold for a REMS is “not necessarily a clear demarcation,” says Tabor. “FDA makes this determination, but it is advisable for companies to anticipate if a REMS may be needed.”
All I am saying is that in my opinion, ARNA has taken a risk with the FDA that may come back to bite them. It is a fact that several of the no votes at the May 10th AdCom for ARNA were by the FDA invited toxicologists. Although most ARNA longs assume the rat cancer issue has been laid to rest, by virtue of the short term rat data and the PWG info submitted, I believe that the FDA may still be considering the cancer risk with LONG TERM use of Lorcaserin. The FDA may require a REMS with a patient registry on this issue alone. Valvulopathy risk is also another possible reason for a REMS.
Only the FDA will decide what is necessary and appropriate for Lorcaserin, prior to approval. If ARNA is unprepared, and the FDA does ask for a REMS, the delay will be potentially significant.