Arena Pharmaceuticals, Inc. (ARNA)

[ferretmoney]

"The FDA can decide it wants a REMS plan at any time up to the final decision on the NDA."

I agree, but to date there hasn't been a safety signal about which to build a REMS program. The company has stated that it has discussed the matter on multiple occasions with the FDA and will prepare whatever educational materials are required. They can certainly remain alert to any issue that could arise, but a more specific program is difficult to visualize when the safety profile has been pretty pretty much an overlay to placebo.