About 10 years ago, I recall the FDA going against an advisory committee recommendation for the flu drug Relenza. The drug ended up being approved despite an advisory committee voting 13-4 against. I'm not holding my breath.
Today's vote surprised me - given the SPA was met, I thought it was going to be closer than 13-1. Mtors with similar AE's have been approved. In the end the committee decided the potential benefits didn't outweigh the safety concerns. I still have a lot of confidence in mTor inhibitors as a class but it's pretty clear that the increased signaling through AKT that occurs with mTOR inhibition limits the drugs effectiveness as a stand-alone drug.
Irregardless, I don't expect the decision to have much impact on the stock price beyond a short-term gut shot reaction. There was very little run up going into today's meeting and, due to the agreement restructuring last year, very little of the Ariads' market cap is now tied to rida. The immediate impact is primarily associated with the $40mm in milestone payments - which represented about $0.25 per share (and accounts for most of the after hour drop). I'm also assuming that ARIAD will also incur somewhat higher sales/marketing expenses as Merck would have compensated Ariad for up to 20 percent of its US sales efforts under the co-promotion agreement.
