Rolling submission is a process in which a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA, rather than waiting until every section is completed before the entire application can be reviewed1.This allows the FDA to receive key portions of the application months in advance, giving them the opportunity to begin reviewing and resolving issues sooner, shortening the overall review time2.Companies can submit completed sections of an application for review by the FDA, rather than wait until all sections are completed34.Illuccix was 6 months
But wasn't a rolling submission
in my mind, Zircaix will be November ???
i don't know how i come up with that ... maybe it was flagged in an announcement ?
Telix Update on FDA New Drug Application Review for Illuccix®Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 17 June 2021. Telix Pharmaceuticals Limited(ASX: TLX, Telix, the Company) today announces that the Company has participated in a late-cyclereview meeting with the U.S. Food and Drug Administration (‘FDA’, the ‘Agency’) regarding theongoing review of the New Drug Application (NDA) for its prostate cancer imaging investigationalproduct Illuccix® (kit for the preparation of 68Ga-PSMA-11 injection). During the meeting, the FDAindicated that there are no outstanding substantive review issues with Telix’s submission.Telix Chief Executive Officer, Dr. Christian Behrenbruch stated, “The late-cycle review meeting withthe FDA continued a series of productive meetings with the Agency and sets the stage for theconcluding phase of the NDA review process, including alignment on the final Illuccix® product label.We remain optimistic about a positive outcome and, accordingly, are working closely with ourcommercial partners to prepare for the U.S. launch of Telix’s lead product for prostate cancerimaging, pending approval. Delivering patient access to this important technology to support themanagement of prostate cancer remains a major corporate objective for Telix.”
(20min delay)