TLT must be using Microsoft excel 98 FROM LAST MAY S QUARTERLY
The Company submitted a pre-Break Through Designation (" BTD ") submission to the FDA in July 2023 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 2Q2024/3Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company will compile a BTD submission for review by the FDA in support of the grant of a BTD approval.