Arena Pharmaceuticals, Inc. (ARNA)

[ferretmoney]

"Please correct me if I am wrong"

Ok, you are wrong, but I trust you would prefer to be wrong. The not-yet-completed BloomDM trial will have no bearing whatsoever on the panel discussion and vote. There is no such gorilla and that's just another FUD card tossed in by the bashers who are desperate to slow this train by any means, facts be damned.

The lorcaserin NDA is complete and missing no data. It is a lengthy presentation (3 million pages) detailing the extensive trials that tested the drug for an obesity indication on over 8000 patients, many over two years a,d all with extensive safety monitoring, and with a well-controlled placebo arm and well-controlled diet and exercise counseling.

What was not a part of the trials was a diabetes indication. Jack Lief has stated on several occasions that the diabetes indication would be part of a supplemental drug application later, following approval of lorcaserin as a single-agent obesity drug with improved risk biomarkers. It would be completely out of place for a panel discussion to wonder what indications might be taken up later. The issue at hand will be the safety and efficacy of lorcaserin for an obesity indication.