ARTICLE | Clinical News
Urocidin regulatory update
October 14, 2013 7:00 AM UTC
Bioniche now plans to submit an NDS under Health Canada's Notice of Compliance with Conditions policy by June 30, 2014, for Urocidin to treat bladder cancer after the agency asked for a clinical assessment package addressing some clinical questions. The company previously planned to submit the application by year end. The Notice of Compliance with Conditions allows for drug approval with the condition that sponsors undertake additional studies to verify clinical benefit. ...