Sunday, June 3, 2012

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.

1 comment:

Condor said...

Well -- it is official. And as has been common when large pharma companies receive such a complete response letter -- Merck is saying it will meet with FDA staffers in the future to work toward a path forward, for a new filing, and a hoped-for approval. However, that path will include new clinical trials, in all likelihood -- so expect a multi-year delay in the USA.

Merck also said it is in discussions with EMEA about what will be needed in the EU to apply for approval.

So it goes.