Kythera submits Setipripant for IND to FDA - 9/22

[Norwood One]

A: The 1992 Prescription Drug User Fee Act (PDUFA) established a two-tiered system – Standard Review andPriority Review.
Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a 10 month goal for a standard review.
Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where none existed. The goal for completing a Priority Review is six months.
For more information, please see the following FY2010 performance report and the Fast Track, Accelerated Approval and Priority Review page.

 

[CarlJohanson]

Thanks dude. So a minimum of 10 months...

 

[Jaym]

What no they haven't even got approval yet to do trials. They then need to do Phase 1,2,3. Maybe they can skip phase 1 because there is already safety data however there isn't any efficacy data in humans for preventing hairloss. This won't be out for a minimum of a couple of years. Look at the time frames for the finasteride or dutasteride studies as they are the other FDA approved drugs for prevention.

 

[CarlJohanson]

Oh... **** that sucks!

How long did it take propecia to go through the fda approval process? I can't find any info on it...

- - - Updated - - -

Ok just read on wikipedia that it takes between 12 and 18 years, fml. We're gonna be stuck with stupid finasteride forever.

 

[Jaym]

Well it shouldn't take a decade. That's usually how long it takes from pre clinics to being accepted. Let's just say it won't be here any time soon.