Liminal BioSciences Inc. PFSCF

RE:RE:Understanding FDA’s Priority Review Voucher System

[7143309322]

skyhigh123 wrote:

skyhigh123 wrote: In order to get your drug designated as a drug to treat a rare pediatric disease you need to submit a rare pediatric disease designation request . And this is strongly in couraged to be submitted at the same time as either as an Orphan Drug Designation or a Fast Track Designation request . How ever it’s not absolutely mandated this be the case , this designation request just needs to be submitted just prior to NBA or BLA submission. After submitting this request FDA will issue a decision within 60 days however and this is a important caveat this does not apply is this request is not submitted along side an Orphan Drug or a Fast Track Designation request .  So again while it’s not required that they be submitted concurrently you do lose this requirement on FDA to issue a decision within a fixed time frame. There’s three potential responses you can get for this request. The disease can be designated as a Rare Pediatric Disease um FDA can not actually BLESS your application as being Rare Pediatric Disease product application until they actually view the material as part of your submission but they can grant a conditional approval at this stage . They can go into your NBA or BLA application with confidence that should nothing change it still should carry that designation. Lastly if neither  of these two happens you can receive a DEFICIENCY LETTER which will explain which  criteria your drug or your program was not eligible for and can allow to go in either , modify your program or just understand why it doesn’t qualify as a rare pediatric disease PRV.

typed this from a video dated December 19 / 2016
sky 

emailed  fred about this

so this is your rewrite?
would not put a penny on this from you.