Looming PDUFA - mixed vote

[Anonymous]

Is it necessary to have a medical benefit or can a drug be approved just because it is labeled an "orphan drug"

Find out this friday !!

 

[Anonymous]

Is it necessary to have a medical benefit or can a drug be approved just because it is labeled an "orphan drug"

Find out this friday !!

Didn't get an interview did you?

 

[Anonymous]

Is it necessary to have a medical benefit or can a drug be approved just because it is labeled an "orphan drug"

Find out this friday !!

Is it necessary to write stupid statements on message boards or can you simply go through life as a fool in silence.

Find out soon (and save the rest of us from your bull$%&/)!

 

[Anonymous]

touchy touchy why so worried about your super drug ? just price really really high and no one will notice that only 400 patients are taking it.

 

[Anonymous]

touchy touchy why so worried about your super drug ? just price really really high and no one will notice that only 400 patients are taking it.

And they will all be thru your patient assistance program.

 

[Anonymous]

and as expected

PDUFA Action Date for Natpara® BLA Extended Three Months to January 24, 2015

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today reported that the U.S. Food and Drug Administration (FDA) has extended the company’s Prescription Drug User Fee Act (PDUFA) action date for its Natpara Biologics License Application (BLA) by three months from October 24, 2014 to January 24, 2015. The FDA extended the action date to provide time for a full review of a major amendment; such extensions are provided for by regulation. In addition, the FDA requested that NPS Pharma submit a Risk Evaluation and Mitigation Strategy (REMS) for Natpara and the company is working to finalize the REMS in advance of the revised PDUFA action date. To date, the FDA has not requested that additional clinical studies be completed prior to the approval of Natpara; however, the company expects a post-approval study commitment.