Marc, unfortunately you are mistaken on current FDA thinking...
Yes, blindness is nasty, but it is not life-threatening. The FDA has been very stringent about giving priority to life-saving treatments. Formavirsen just simply doesn't qualify -- its no more important than a lot of the 50+ drugs awaiting review.
You overestimate the AIDS lobby's current powers. First of all, the AIDS lobby was quite vocal in getting various protease inhibitors approved. However, they have been virtually silent on drugs for AIDS-related diseases (like CMV). Also, the FDA is much less sensitive to lobbying right now. The FDA succumbed to heavy lobbying after they originally voted to reject Redux. For a while there, it looked like they might face a thalidomide-type backlash when Redux was withdrawn. I assure you, the FDA is much less prone to being lobbied right now. Part of my job is to monitor the FDA and which way the winds there are blowing, so I feel very confident in that statement.
I hate to say it, but Formavirsen just isn't going to be a priority for the FDA. As this is the first antisense NDA, you can be sure that they will go through this with an intensely fine-toothed comb. I agree that blindness is bad, but the FDA is reviewing drugs for Parkinson's, MS, sepsis and other life-threatening diseases. Also, Formavirsen isn't a cure -- it just delays it longer than the other drugs. Combine all of those factors, and you have an above average reveiw time (which I am mitigating by assuming that Isis's system investments will help speed it along).
sds |
