Arena Pharmaceuticals, Inc. (ARNA)

[ferretmoney]

MATTHEW HERPER is a tool, in my not very humble opinion.

1. Qnexa'a panel rejected it soundly because of the known risk factors of the component drugs, each dangerous in its own right. Vivus had put forth a nebulous premise that two two components somehow [magically?] mitigated each other's negatives. No science was put forth to support this strange argument and no REMS was going to be sufficient to overcome the known risks associated with topiramate without broader and longer studies.

2. Fenfluramine was solely responsible, and it has been demmonstrated scientifically, for the valvulopathy effect that took Fen-Phen down. Phentermine has been in limited use for a very very long time and has serious cv risk associated with it, but never has it been associated with valvulopathy. It was not the combination of fenfluramine and phentermine that torpedoed Fen-Phen and Herper has to know that.

3. Lorcaserin revealed no risks during trials that might warrant a REMS, and 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.

4. Lorcaserin is a single agent, not a combo agent. The FDA "suggested" to Arena not to trial it with phentermine and Arena followed their advice (publicly stated by Arena CEO). I find preposterous the proposition put forward by some analyst [Wei, another tool imo] that the FDA should now require test data for a combo that will be cautioned against on the label.