NuPathe Inc (fka PATH) (PATH)

[smittygoodcall]

I like their chances for approval, the only thing that worries me a bit is their CA study waiver justification. I think they seemingly have addressed all other FDA concerns. I really believe that the FDA would have told them exactly what they needed to justify the waiver or the FDA would have flat out told them they needed to do the CA Rat study before approval. If the FDA told them to do another study, I would think PATH would have disclosed that and I also think they would have done the study. The end of review meeting that they had with the FDA is where PATH would have been given all the things they needed to do in order to address the CRL. I think the change in mgmt was positive and my guess is the new CEO isn't going to take chances, he will have PATH's ducks in a row.