Rocketman, you are correct that the FDA does choose to go up against their advisory panels on occasion.
In this instance it is not necessaty for the FDA to reverse the conclusions of the advisory committee to approve myotrophin as the panel never "rejected" it in the first place.
Refer to Kurt Vedder's reply (#343).
Also,in my last direct reference on this board to The Dermatologist, I would reply to your previous statements: <<Ceph has taken advantage of a group of seriously sick people with
ALS. i think it would be ashame to continue leading these poor people on with the
promise of a drug that has shown absolutely no benefit, and even kills some of the
people who trusted ceph enough to enter their clinical trial.
i don't know if you guys really care about people with als, or you just want to make
money off of them. the bottom line is that the patient comes first, and thank god the fda
is there to protect them from charlatans like ceph.>>
We also need the FDA to protect us from such "charlatans" as Dr. Bob Miller of the University of California San Francisco, Dr Benjamin Brooks of the University of Wisconsin, and Dr. Ted Munsatt of Tufts University and Chairman of the World Federation of Neurology, all highly respected ALS physicians who are widely regarded as the leading clinical experts in this disease, and who all spoke before the advisory committee about their more than satisfactory experience with myotrophin from the T-Ind or clinical trials, and who urged for the need to approve myotrophin now. |
