THe FDA Adv. Committee Meeting on Mar. 27-28 is NOT about ARNA; It's a meeting to discuss simply cardiovascular issues re: anti-obesity drugs. The meeting to specifically discuss ARNA's Lorcaserin will be held, as previously announced, on May. 10.
One assumes that at least some of the time these drugs will be used together with physical exercise. The issue of CV side effects is real even if they are "mild" at rest. I believe Lorc. enjoys a very significant advantage here.
H'lo doc... even though this is true, interest in briefing docs for this AC is to see what kinds of cardio indicators they intend to cover. Having said that, since this AC is more of a technical seminar (rather than a NDA review), do you know if there will be briefing docs?
Does our drug even have any heart related issues I now vvus does and in fact I am buying puts right before that FDA meeting As I think they will want more heart related studies But ARNA is without cardiac issues correct?
I don't have additional information re: how many members will be on the Advisory Committee on May 10. I'm not aware of any negative cardiovascular effects of Lorcaserin---but---for those who are interested, the NEJM article 2 or 3 years back has most of the Lorcaserin data---EXCEPT--the rat cancer studies. THAT appeared to be the stumbling block in the first meeting; If ARNA has successfully addressed THIS issue, I'd predict the Advisory Committee will vote in favor.