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jq1234

12/08/10 9:22 AM

#110423 RE: DewDiligence #110422

In addition, don't assume it is going to be big seller EVEN IF it gets approved. With strong REMS, it might not sell at all.

JJM760

12/08/10 9:24 AM

#110424 RE: DewDiligence #110422

They def benefited from batting third.

ilpapa

12/08/10 10:32 AM

#110435 RE: DewDiligence #110422

Given that there are millions of overweights looking for a painless in-a-bottle way to lose weight, there would be a firestorm against the FDA if it was not approved.

jb_118

12/08/10 10:44 AM

#110438 RE: DewDiligence #110422

Contrave isn’t a lock to be approved just because the advisory panel voted in its favor.



I'd agree with this. Nobody on the panel loved the drug. Whether most of them voted "yes" or "no" seemed to depend on how they felt requiring longer term studies with CV outcomes would affect the development of obesity drugs in general. One panel member said this drug is sure to be a failure when the additional study gets done. He obviously voted no.

I didn't listen to Advisory panels for the other obesity drugs, but saw fair amount of people on the blog of the opinion that either of the other two would have passed this Advisory panel.

pcrutch

12/09/10 8:39 PM

#110598 RE: DewDiligence #110422

I don't think the FDA will approve it either. That would put them in quite the precarious position of accepting a drug with less safety data than other competitors with somewhat questionable efficacy.

It also doesn't help that Public citizen and Sid Wolfe are now gunning for non-approval of Contrave. I also think Dr. Kaul is about the only trustworthy panel member. He is a straight shooter.

FDA is going to ask for another trial.

http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3232

http://www.citizen.org/hrg1922