This Endo trial - complement of Ph IIIa ?Could it be simply to collect complementary data requested by FDA about Urocidin safety - since its not a comparative analysis vs BCG and the primary endpoint are at 1 year.
The second phase III was supposed to enroll about 800 patients - if my memory os good - and to compare vs BCG
https://au.sys-con.com/node/1031117
" Bioniche plans to conduct a second registration trial that will
directly compare the efficacy and safety of Urocidin with current therapy in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, Bioniche announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. With Endo's support, Bioniche will commence this multi-centre trial, setting up clinical trial centres immediately.