I heard that the FDA wanted 2 more P3 trials...
One for papillary and one for CIS patients, each with a 5-7 year time frame. TST was unable to find anyone interested in investing in MCNA with this proviso from the FDA in place. In addition, Ipsen decided it was not rational for them to continue to develop MCNA in Europe/ROW. I heard this info from TST management in an email exchange the day after the 2 Aug PR after I contacted them to complain about the absolutely disappointing news. I see that many of you are holding onto hope that a second offer may emerge or that somehow someone will rescue MCNA from the shelf. My best guess is PLI might just be that company as they could potentially run those trials. However, in the meanwhile, other immunotherapeutic molecules are already in play for this indication from other companies and I'm afraid the window of opportunity for MCNA approval has closed. It is beyond awful for investors but IMHO even more so for NMIBC patients that this has happened. GLTA