Orexigen (OREX): Contrave Panel Vote Analysis and Estimate
Orexigen (OREX), Vivus (VVUS), Arena Pharmaceuticals (ARNA)
Ok so let me go through my Orexigen vote estimate. I'll try to give a brief description next to each panel member and why I think they will vote the way they will. at the end of the analysis I give my final panel estimate. You are highly encouraged to go back and review the Qnexa, Lorcaserin, and Meridia panel transcripts on your own.
The No Votes
Abraham Thomas- I think Dr. Thomas will vote no. He had noted at Qnexa's panel hearing that, "The current medications available are not very effective and have a lot of side effects. the sponsors did an outstanding job of proving the efficacy, and this medication in terms of efficacy is far superior to anything that’s on the market. the concerns we have are with safety." He then went on to list a number of concerns, one of them being patients that have a history of Myocardial Infarction and the fact that on Qnexa MI's happened only on their drug. Which just happens to happen to 3 patients on Contrave and none on placebo as well, so I don't see this doctor doing a change up for Contrave, especially given the much weaker efficacy of the drug.
cont’d on next page
- Previous Entry: MELA Sciences (MELA): CE mark Process Explained
- Next Entry: FDA Delays Human Genome Sciences' (HGSI) Benlysta PDUFA
Orexigen (OREX): Contrave Panel Vote Analysis and Estimate
lorcaserin, medication, myocardial infarction, qnexa
No comments:
Post a Comment