RE:RE:From 6 months down to 5 months approval time...I like Doug Loe's analysis:
"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."