Case Studies and Examples FDA So I've been reading about some of the possible scenerios which may happen this monday, Ill just summarize a few, in my knowledge (I am a UBC PHARM student), there will inevitably be a possible delay, but can come with good news which is why i was willing to but on Friday, I read there Trial results and though..There is some complexity to the study as it is hard to find Bladder cancer patients to satisfy a NNT as well as this being a cancer drug, but i beleive that the drug itself has potential and if the company satisfys the FDA's reccomendations made from the appeal in the TYPE A meeting we might see this drug approved sooner then later (being optomistic) and we might not need another PHASE trial (hopefully). Ps excuse the spelling doing this on my phone on my wat back from a final exam lol.
Case study A:
Drug was appealed, did not have a sutiable sample size hence was rejected --> Company set fourth a new study design and was conducted --> Was aloud approval upon interm data (still needed to conduct another phase trial however...)
Case study B:
Drug was appealed, "did not show efficacy" --> FDA responded to appeal and said approval is not out of reach and report additional information on trial results (eg.ongoing health state of subjects, data which was excluded ect" --> Took lengthy time for company to give everything it required --> Drug approved ~a year laterir
Drug was appealed, "Did not show Safety" --> FDA responds (include any thrid party data, and or additional data which was excluded" --> Company submitted additional DATA, as well as Analysis done by a third party w/no conflict of intrest --> couple months later after resubmissions FDA accepted approval as additional information was enough --> Drug approved ~ a year later and no phase trial was re-conducted