RE:Realstock is right: Arakis and clones here post disinfoAcceptance is one of the first steps in the review process.
LMNL submitted the BLA per their NR on April 5, 2017
(Click Here for NR).
Obviously something was screwed up; it took the FDA 6 1/2 months to do one of the first steps, accept the application.
Also, last sentence explains the refusal-to-file decision. They coudn't complete CMC in 30 calendar days.
2.1 Receive Submission
The application review process begins upon receipt of the application. The PDUFA time clock begins on the FDA receipt date except for products submitted under “The Program” (i.e., NME NDAs and original BLAs). For these applications the PDUFA time clock begins 60 days after the application receipt date if the application is filed; however, the review timeline for all applications begins on the day of submission.
The application is received either in hard copy by the Central Document Room or electronically in the Electronic Document Room and is processed (control number assigned, date stamped, and an electronic archive record created or updated as appropriate). New applications are forwarded to the assigned review division’s Chief Project Manager. Paper submissions are to be received by the division’s CPMS/RPM by day 3 after receipt in the Central Document Room. Electronic NDA/BLA submissions on physical media are loaded in the Electronic Document Room by 3 business days from receipt at the Central Document Room. Electronic submissions may also be received via the Electronic Submission Gateway (ESG or “the Gateway”).
Any Program application components that FDA agreed could be submitted after the original application must be received not later than 30 calendar days after receipt of the original application. Missing components may lead to a refusal-to-file decision.
Newcamo wrote: Prometic Announces FDA Acceptance of its Biologics License Application for Plasminogen (Ryplazim™)
- Prescription Drug User Fee Act (PDUFA) action date is set for April 14, 2018
- Ryplazim™ previously granted Fast Track, Rare Pediatric Disease and Orphan Drug Designations by U.S. FDA
LAVAL, QC, Oct. 13, 2017 /PRNewswire/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) having granted a priority review status and set a Prescription Drug User Fee Act (PDUFA) action date for April 14, 2018, Ryplazim™ had previously been granted Fast Track, Orphan Drug and Rare Pediatric Disease designations by the U.S. FDA.
"The acceptance of our BLA filing and setting of the PDUFA date by the FDA is a significant milestone for Prometic", said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. "The FDA has recognized the seriousness and unmet need of available therapeutic solutions for plasminogen deficiency, granting orphan, fast-track and rare pediatric disease designations. We will continue to work closely with the FDA in the coming months with the goal of making our plasminogen replacement therapy Ryplazim™ available to patients as soon as possible".
The FDA grants Rare Pediatric Disease Designation for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents. If approved, Prometic's plasminogen replacement therapy will be eligible for a rare pediatric disease priority review voucher (PRV). The grant of the priority review was another important pre-requisite for Prometic's eligibility for a PRV.
Prometic has previously reported data from this pivotal Phase 2/3 trial, which showed that RyplazimTM treatment consistently replaced and maintained the plasminogen concentration at an appropriate level and that it resolved all lesions in all patients treated.
About Plasminogen
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.