J&J responds to Reminyl “not-approvable” letter
Executive Summary
Johnson & Johnson has responded to FDA's "not-approvable" letter for an extended-release formulation of its Alzheimer's agent Reminyl (galantamine), company says at Bear Stearns health care conference. J&J says FDA's concerns relate to "some statistical issues around the interpretation of our studies." Company received the "not-approvable" letter in December (1"The Pink Sheet" April 19, 2004, p. 12)...
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