MF followers aside, there was one other FDA decision that may have spooked some observers, besides Dendreon. Somaxon had been told that they could file the carcinogenicity data for Silenor (low-dose doxepin) in insomnia post-NDA filing. Suddenly (if Somaxon is being truthful about it, and they'd be crazy to have made this up) the FDA reneged, and decided they can't file the NDA until the carcinogenicity data is complete--on a drug that has been used for forty years at much higher doses. This delays the NDA by at least six months.
For some, this is another example of not counting on the FDA to--not only do the right thing--but in this case, do what it said it would do. I do not think this is pertinent to Cortex, because it relates to the final steps before marketing approval. Allowing a Phase II trial to proceed is a much lower profile step. But it could unnerve those who are already leery of relying upon the Agency to act rationally.
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