RE:RE:RE:1St quarter BTDFrom today's 2nd news release. Sounds like pre BDT submission was done, but sent back with a request for clarification. Plan is now to revise & resubmit pre BDT in early Q1 and then submit the actual BTD submission later in Q1.
Break Through Designation Update
The Company has submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the Clinical Study Sites ("CSSs"), a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in early 1Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval in 1Q2024.