Arena Pharmaceuticals, Inc. (ARNA)

[DewDiligence]

Arena has publicly stated that they were ready to launch a REMS should the FDA require one but that the FDA had in their many discussions advised that it would not be required.

The FDA can decide it wants a REMS plan at any time up to the final decision on the NDA. Whether the FDA ends up wanting one in this instance may depend on input from the advisory panel.