CT re 12,000,000 new bladder cancer cases worldwide each year....Dr. Berendt spoke to the cost of treatment for bladder cancer is approx $230k per patient (I assume this is a U.S. cost). Based on 2010 figures which he then emphasised would likely be higher today. In answering a question if there might be any concern having U.S. health insurance covering the cost of MCNA?...he did not indicate/assume this should be a potential issue. Now, one more figure provided relating to the reason MCNA did not receive Orphan Drug Designation.....with the FDA hurdle being under 200,000 potential patients in the U.S....apparently the FDA was concerned with the potential of MCNA being used "off-label" as treatment for patients of a much larger target population exhibiting "prevalence" of low grade bladder cancer --- the figure was quoted as approx 600,000 in North America each year. He then quoted that the reoccurrence rate is approx. 70-80% within two years. He emphasized "off-label" mkt usage discussion is illegal. I think Press Release re ODD was well written as anyone in business would read between the lines. Keep in mind MCNA target population is for high-grade non-muscle invasive bladder cancer patients who have failed BCG therapy, i.e. BCG-refractory or BCG-relapsing, at less than 10,000 patients per year U.S..... Anyways, if all goes to current timeline...Dr. Berendt suggested the BLA could be approved as early as "end of 2015" if it receives "priority review" otherwise, potentially in early 2016. Recall from previous post....their goal is to be in production/ marketing/ selling the next day...i.e., no lag period to ramp-up. Hopefully PPT slides from AGM posted today. rg