Feb
02
Feb
01
Arena Pharmaceuticals said the FDA has decided to hold another Advisory Committee meeting in the second quarter. My guess would be around May 15. The purpose of an Advisory Committee normally is to advise the FDA on unresolved scientific issues. In this case, I think the purpose is to decide if all the issues from the last Advisory Committee meeting have been resolved. ARNA is only down a penny in the aftermarket, but I expect this news to hit the stock harder once the shorts twist the story. Because I do not believe there are any unresolved legitimate issues left, I don’t think this will delay approval.
Jan
12
There is a new edit function that opens in a new window. Seems to work well so far.
Jan
10
Good news from BioCryst (BCRX) on the Phase IIb safety study of BCX4208 for gout, and a very good presentation by Dendreon (DNDN) at the big JP Morgan Healthcare Conference. QuickLogic (QUIK) announced after the close that revenues fell short due to sales of legacy products, but new product sales were higher than guidance, which should limit any damage to the stock. They are at the Consumer Electronics Show starting Tuesday in Las Vegas.
I don’t know what to make of the Vivus (VVUS) news that the FDA has asked them to remove the label contraindication for women of childbearing age, while leaving the label indication for women who are pregnant. It makes no sense. If this was any other company, I would say the FDA is sandbagging them for an Advisory Committee turndown on February 22. It makes it much harder to have a practical Risk Evaluation and Mitigation Strategy (REMS), and any Advisory Committee worth its salt would put the women of childbearing age contraindication back in.
But we know Vivus has a “special relationship” with Deputy Director Eric Colman, who seems determined to get the drug approved, so the whole thing is baffling. In practice, I still think doctors will be hesitant to use Vivus’ Qnexa until after a woman of childbearing age has been unable to lose weight on Arena’s Lorqess.
