Replies to post #134252 on Biotech Values

[DewDiligence]

Most of ARNA’s CC was about new analysis of the rat-carcinogenicity data. VP of clinical development, Christy Anderson seemed well prepared for the questions from the apparently skeptical questioners, especially when elaborating on the two distinct pathways for pathogenesis of rat mammary tumors.

Whether this makes ARNA a compelling buy at an enterprise value of roughly $300M is unclear. My cursory answer is no, but I’d be somewhat more inclined to take a flier after today’s news than I would have been previously, even after accounting for the double-digit price gain in the AH session.

[iwfal]

ARNA -

I'd be interested on your take on this, as there's a lot of $ to be made or lost. From experience one needs to do some serious reading between the lines on any statment made by ARNA. However what I do know is that a few people at ARNA that I know have held steady for a long time, makes me think there is a major belief in this internally.

Suggest that this isn't a stats issue - but an issue with the FDA wanting absolute certainty on safety with a chronic drug that is likely to be very very popular if approved. Short of ARNA running a huge human safety trial I think they have less than 10% chance of approval now or ever.

[DewDiligence]

Lorcaserin PDUFA date for resubmission is 6/27/12:

http://finance.yahoo.com/news/FDA-Accepts-Resubmission-prnews-2044611612.html?x=0

No comment in this PR on a second FDA advisory panel for Lorcaserin, but ARNA said on its recent CC that such a panel was possible. If a panel is not scheduled fairly soon, I would consider it a modestly bearish signal.