RE:RE:RE:article MCNA's PDUFA (Prescription Drug User Fee Act) date is in late February 2016. We believe the FDA could disagree with its advisory panel and approve MCNA as an early-stage bladder cancer therapy in patients who no longer responding to BCG but would prefer to delay removal of the bladder, if possible. The drug exhibited a one-year disease-free survival rate of 25% in an open-label, 129-patient Phase 3 study.
If you believe a trial with these descriptive elements is insufficient for approval, you are not alone; 18 advisory panel members agree with you! However, the FDA and the American Urological Association disagreed in a mutually endorsed set of clinical protocol guidelines published in 2014 in the journal Urology, and this stands as our best evidence that key regulatory leaders believe MCNA performed sufficiently well to be medically useful in BCG-refractory disease.
Source -> https://www.streetwisereports.com/pub/na/a-bucket-of-canadian-stocks-set-to-soar-in-2016-euro-pacific-canadas-doug-loe