In fibromyalgia and its ancillary indications, I think companies need two solid pivotal trials to have a good chance for approval. If FRX and CYPB try to pull a “Dendreon” and go to the FDA with one good trial and one that’s merely “supportive,” I think they’ll likely end up with an approvable letter.
Why? Lots and lots of drugs are approved on one positive trial with much much poorer supporting data than p=0.06. (This is not meant to be confrontational at all. Just curious why you would say something so at odds with obvious history. Drug class? Indication?)
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