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FDA staffers raise doubts over key Vertex combo
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- Publication：2015/5/11
As an FDA review nears for Vertex's ($VRTX) Kalydeco-lumacaftor tandem--approval of which could help Kalydeco reach 10 times the number ofcystic fibrosis patients it currently does--the agency's staffers have some concerns. Friday, they raised doubts over whether experimental add-on lumacaftor actually made any significant contribution to outcomes in patients with the F508del mutation.Story | More