FDA staffers raise doubts over key Vertex combo

As an FDA review nears for Vertex's ($VRTX) Kalydeco-lumacaftor tandem--approval of which could help Kalydeco reach 10 times the number of cystic 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

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