Genelux recently received FDA Fast Track Designation for our ongoing Phase 3 trial. This designation reflects the FDA’s recognition of a product’s potential to address serious unmet medical needs. The development and review of Olvi-Vec will have benefits such as potential increased communication opportunities, rolling review, priority review, and possible accelerated approval as the trial progresses.
Sponsors with Fast Track Designation receive timely feedback and can submit portions of the application for review as they become available. While the designation streamlines the approval process, the fundamental requirements for conducting rigorous clinical trials remain unchanged. Overall, fast track designation is intended to enable Genelux to efficiently develop our promising treatment and ensure quicker access for patients facing urgent medical conditions.
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Chief Scientific Officer at Zentalis
4moFantastic milestone. Great to see the progress made towards being a leading oncology precision medicine company