Wow!
Congratulations first and foremost to those that are long on OREX! I also want to say congrats to those analysts that remained positive on Orexigen even in the face of negative panels for Vivus’ Qnexa and Arena’s lorcaserin. And of course, the company deserves some (dripping sarcasm) credit.
The phrases that were repeated over and over were an efficacy that passed ‘by the hair of its chinny chin chin’ and a caution against an agent that could be considered ‘Sibutramine II’. In the end, Orexigen put together a strong enough defense against those accusations, along with a solid REMS program, to mitigate the panel’s concerns. While this doesn’t guarantee approval, the FDA generally follows its panel’s recommendations.
The votes for question 6 (Should additional CV study be carried out pre- or post-approval?) and 7 (Do benefits outweigh risks for Contrave/NB? Yes/No.) were as follows:
Felner – Post, No
Goldfine – Post, Yes
Thomas – Post, Yes
Weide – Pre, No
Balish – Pre, Yes
Bittner – Pre, No
Coffin – Post, Yes
Flack – Post, Yes
Gardner – Post, Yes
Heckbert – Pre, No
Hendricks – Post, Yes
Hiatt – Post, Yes
Hirsch – Post, No
Kaul – Pre, No
Morrato – Post, Yes
Oakes – Post, Yes
Proschan – Pre, No
Rogawski – Abstain, Yes
Seely – Pre, Yes
Spruill – Pre, Yes
Disclosure: No positions.
Wow, I didn’t expect this, I can see OREX going through the roof now!