Bioniche Life Sciences Inc.’s Mycobacterial Cell Wall-DNA Complex (MCC- Uricidin™) has been granted Fast Track designation by the USFDA for the treatment of non-muscle invasive bladder cancer in patients who are unresponsive to Bacillus Calmette-Guerin (BCG), the current standard therapy.
Last February, this research-based, technology-driven Canadian biopharmaceutical company (Bioniche) announced that the FDA approved its Phase III clinical trial with Urocidin in the treatment of this patient population.
In lieu of this Fast Track designation, once the Phase III clinical trial data becomes available, Bioniche Life Sciences Inc. could expect an expedited review of its Biologics Licensing Application for Urocidin.
Source: Bioniche Press Release
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