FOR EVERYONE CYDY is well within the FDA’s 30-Day Provision
Credit: Another CYDY share holder shared this. Cytodyn’s Recent Update of BLA Fully Complies With FDA’s 30-Day Provision
For the record, Cytodyn’s original BLA filing on April 27, 2020 and subsequent update by May 11, 2020 is well within the 30-day period expressly provided for by the FDA.
The FDA’s official manual states: “Applications under the PUDUFA Program are allowed to submit stability and clinical safety updates not later than 30 calendar days after receipt of the original application.”
SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Version: 9 Effective Date: February 17, 2020; p.16 D. Filing Decision https://www.fda.gov/media/85659/download
This routine 30-day provision for updates to a BLA after the original application is filed was built into the system by the US Congress to allow for close two-way communication between the PDUFA applicant and the FDA. This provision ensures a more efficient, complete, and effective application process.
The Prescription Drug User Fee Act (PDUFA) applies to applicants submitting BLA’s for biological drugs. Since Leronlimab is a biologic drug, Cytodyn is a PDUFA applicant. This involves payment of a significant fee and fully entitles Cytodyn to all the provisions and exceptions outlined for PUDUFA applicants. This includes the aforementioned provision to update a BLA within 30-days after the original application is filed.
Please refer to the following official FDA guidelines: https://www.fda.gov/media/85659/download
Center for Biologics Evaluation and Research SOPP 8401
SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Version: 9 Effective Date: February 17, 2020
p. 16 of 35
D. Filing Decision 26. … a. Refer to JA 910.06: Completing a Filing Review for additional information. b. Ensure that the application contains the information and data agreed to during the preBLA/NDA meeting, except for applications under the PDUFA/BsUFA Programs. i. Applications under the PDUFA Program are allowed to submit stability and clinical safety updates not later than 30 calendar days after receipt of the original application.
For further reference: https://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments
Background and Legislation
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process. https://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act#PDUFA_I
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.