Formal FDA “Rejection” Letter — On Ridaforolimus — Due Out, Tuesday?


We had long ago reported on this, but I think Spencer Knight is right, that the complete response letter — the formal rejection, that is — will arrive at Whitehouse Station (and/or Ariad headquarters) on Tuesday morning:

. . . .The first FDA decision of the month will be a solid rejection for Ariad and Merck’s Taltorvic [the proposed brand name for Ridaforolimus]. Taltorvic has been developed to treat patients with metastatic soft tissue or bone sarcoma that have not seen an increase in sarcomas after four cycles of chemotherapy. On March 20, 2012 an Advisory Committee voted 13-1 against the approval of Taltorvic for the intended treatment. . . .

It should be a non-event, as to Merck’s stock price — as the news is completely factored in.

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