BriaCell has received agreement and positive feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor, in advanced metastatic breast cancer.
After reviewing BriaCell’s Fast Track designated Phase I/IIa data, the FDA has agreed on the primary end point, the essential elements of the pivotal registration study design, and type of patients to be included.
Registration study success could lead to a Biologics License Application (BLA) submission and commercialization approvals for BriaCell’s novel immunotherapy approach.
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