RE:This was the problem in the trial...That is a deficiency in the submission and not a problem with the trial. The FDA probably knew that this was a single arm trial when they encouraged Telesta to proceed towards a BLA. They may have even read the AUA article in April 2015. The FDA needs to now respond with what kind of trial is required so the protocol can be established, with agreed to endpoints with a bow on top and sold. I doubt management, like shareholders, has the stomach for another 5 years plus of any of this BS. For a pharma this is another day at the office, not a near terminal coronary. Let them run with it.