DNDN- Your convinced that Provenge shows efficacy, the advisory panel displayed this with their vote, and the FDA only issued an approvable letter due to political and financial pressures by doctors and pharms scared that immunotherapy would become the next standard of care.
Its interesting that MRK did not run into problems gaining FDA approval for Gardasil. Look at all the dollars left on the table because these females will not develop cervical cancer.
I know there is alot of argument that no one would be hurt by the approval. I disagree, it sets a bad precedent that outside interests could pressure the agency into adopting a favorable decision.
The FDA requires substantial evidence of efficacy for approval. The Provenge results do not support this conclusion and thats the only reason the FDA is asking for additional support.
The 13-4 vote was for not for the question of "substantial evidence of efficacy", but rather for "Is there substantial evidence the product is efficacious". So the advisory panel was voting that Provenge was capable of producing a positive effect not that Provenge showed substantial evidence as required by the FDA guidelines.
I know its impossible to look past the conspiracy theories, but its alot simpler, FDA needs more data. The FDA has written/formalized guidelines for approval for this very reason and they would have to change them based on outside pressure to grant Provenge approval.
AI
