Biowatch , I think your commentary on the AC panel discussion really cuts to the chase.
What cancer patients are saying is that they want access , now , to treatments that are less-than-perfectly characterized , or those that might be statistically imperfect , as long as there is a reasonable chance of benefit and little chance of harm. The panel reflected that in a tempered way since they consider the issue from a more detached viewpoint and consider other things , like the possibility of wasting healthcare dollars on ineffective treatments , for example.
The important thing to remember is we're talking about patients with essentially no options. Taxotere is such a poor option that it is often refused. Nobody is suggesting lowering the standards for the next hot new laxative. If ten drugs like Provenge are approved and one eventually fails confirmation , I would consider that a huge overall success. Many more people would have been helped , sooner , as a result of this progressive policy and more would be learned about all ten drugs in a short time after approval than was known in total beforehand , as various researchers test their own theories on them. One of the FDA stat people originally estimated the false positive probability ( for survival advantage ) of Provenge at 1 in 40. In this situation , that's a slam dunk , IMO.
The CVA issue is a red herring. If I was a cancer patient I would be happy if I knew I was going to live long enough to have a chance of a stroke. If I had the stroke , I would look on it as an opportunity to learn a new language.
The CU issue is another red herring. It's a way for the FDA to blame the failure to allow access to the drug on the company. If it's safe enough and effective enough to allow CU , it's safe and effective enough for a conditional approval. It's not the patients' faults that the FDA hasn't figured out yet how to do a conditional approval. It's about time they do.
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