RE:RE:RE:RE:RE:RE:RE:BTD timeline...In line with what I always posted; 25 patients @450-days
1. Break Through Designation Update. In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.
In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites (“CSS”) availability to complete all required assessments.
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ScienceFirst - (4/25/2022 12:24:51 PM)
RE:RE:RE:RE:RE:RE:BTD timeline...
- Only data of Ph. 2b
- On the first 25 patients (not only the optimized as the FDA doesn't allow sub-groups)
- Data @450-days for the 25 patients
That would allow the FDA to take a sound decision.