RE:RE:RE:RE:Missing biomarkers in MNCA trialHT: There's a great review paper in Therapeutic Advances in Urology (Feb 2016) that's very positive about MCNA...one of the authors is Steinberg who was in the PIII MCNA study (also a consultant for Endo)...it has some very useful stats. I think it would be difficult to do a 2-arm study comparing MCNA against BCG given BCG's 70% disease free survival (dfs) rate at 5 years. A more doable study would be against the only second line treatment approved by the FDA: valrubicin. It has a reported 2-year dfs of 8% versus MCNA's 2-yr dfs of 19% (I'm getting my numbers from the paper). Head to head with those reported dfs levels, a study would need 150 patients per arm just to confirm that outcome (this is calculated based on the expected % difference between the 2 treatments combined with the required statistical power of the study etc.): any better performance by MCNA (ie higher dfs compared to valrubicin) would show up with fewer patients per arm at any interim analysis. The side effect profile of MCNA is much better compared to valrubicin so this would be a doubly impressive trial (hopefully) and would go a very long way toward getting MCNA approved as the gold standard second line treatment. That would be a start and then, given the shortage of BCG, perhaps MCNA might slowly gain acceptance as a potential first line treatment, especially for those unable to take BCG and unwilling to have the surgery. I actually think given the BCG shortage there may well be patients who would gladly take MCNA without any future trials....but it depends on their docs and the FDA giving compassionate approval at this point. https://www.ncbi.nlm.nih.gov/pubmed/26834838