Matrix IntraDose “not approvable”
Executive Summary
Matrix' IntraDose (cisplatin/epinephrine injectable gel) receives "not approvable" letter from FDA Nov. 2. The letter reiterates agency concerns raised at the Sept. 10 advisory committee meeting for the head and neck cancer agent, Matrix says (1"The Pink Sheet" Sept. 24, p. 30). The company is "continuing to explore with the FDA the next steps for IntraDose." Phase II trials for other cancer indications will not proceed to Phase III, Matrix says...