Just read this article...........
http://www.marketwire.com/press-release/...UXL-956331.html

Here are the main parts:

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for XIAFLEX™ (clostridial collagenase for injection), a novel, first-in-class, orphan-designated biologic for the treatment of Dupuytren's contracture.

Auxilium has requested Priority Review designation for this BLA submission from the FDA. The Company expects to hear back from the FDA on Priority Review designation within approximately 60 days from the filing date. If granted, the FDA, per Prescription Drug User Fee Act guidelines, has up to six months from submission date to take action on the BLA. Priority Review may be granted to drug products that provide treatment when no approved pharmacological treatments exist for a disease.

Edited 03/03/09 18:12

I don't mean to be condescending but the decision should be scientific not political, with that said, politics sometime mixes into the F.D.A.'s decision making when it shouldn't.
J W

I agree that it should be a decision made by scientists. Getting Xiaflex on a fast track would not and should not compromise the efficacy of the study or the decision. It doesn't have to be political. Do you have any ideas?

Maybe contacting FDA with how it affects us would call attention to it and this study might be moved up in the pile so that it could be reviewed sooner.

There have been other drugs that have been expedited by the FDA because it was of a benefit to the public to get it to the market sooner rather later. Case in point,

"Clinical Review Herceptin@
BLA 98-0369
4.0 METHODOLOGY OF THE CLINICAL REVIEW - OVERVIEW
4.1 Clinical Studies
This Biologics License Application (BLA) for Herceptin@ was granted priority review
status and fast track designation; the sponsor was permitted to submit the contents in a
rolling fashion with a complete application filed on May 4, 1998. . ."

True, Dupuytren's is not life threatening as is breast cancer, but it would certainly be wonderful to soon have another alternative and very promising therapy for a lot of people with this debilitating disease.

Does having NA done now preclude having Xiaflex treatments later?
Thanks