Although an FDA panel said that more research is needed before it could approve CV's Ranexa, a treatment for chronic angina, analyst Thomas Wei says the panel was more positve than he expected. Wei says 5 of 11 FDA panel members recommended outright approval of Ranexa, with the rest recommending that additional data be submitted before approval.
Wei says the outcome and the general tenor of the panel is much more positive than the tone of FDA documents from Dec. 8. Of panel members suggesting additional data is needed, some expressed Ranexa is "close to approval." Wei thinks CV Therapeutics will need to supplement its new-drug application with more data, but he says the data requirements could be modest.
Wei is keeping his second-half 2006 approval timeline, but sees the potential for upside to this timeline based on the panel's comments. He's also keeping his outperform rating on the shares.