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.
********** The FDA will not disclose information regarding sponsors who have been granted or denied breakthrough therapy designation. FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request. ---- Insmed does not have to say a word. - clever (or hidden in a PR coming? )).Everyone is positioned. I am on the sidelines.....we shall see. Good Luck -no trading,surfs up!