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Insmed Incorporated Message Board

  • gertrude_theduck gertrude_theduck Jun 13, 2014 11:51 AM Flag

    Reply to Breakthrough status much ado about nothing ? by terry_insm

    FDA commissioner Margaret Hamburg's answer to the criticism that the FDA was not approving drugs 3 or 4 years ago.3 approvals out of say 50 given the status in 3 years.Anyone know the decision date?

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    • Breakthrough status is in fact the same as fast track but with a vague "guidance" from the FDA to speed up approval. Some observers think the FDA is actually favoring too many candidates and thereby diluting its resources through expedited review programs, thus diluting its resources so much that in fact none of them will see much difference in the approval shortening time.
      Also other agencies around the world may not accept the FDAs decision. Pharma agencies around the world are notoriously snobby.
      -On the face of it, I think Arikayce should receive the status,but if it doesn't , I really don't think its that big a deal. Traders will use it as an excuse to move it up or down.
      -IMHO - the regulatory pathway yet to be determined is more important. A mandated Phase3 trial will affect the company far more.

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