RE:RE:TLT will get BTDThe Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD submission with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 4Q2024 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 1Q2025 in support of the grant of a BTD approval.
What kind of clarifications this stupid FDA wants. Just look at the commercials on TV with drugs and huge side affects all approved.
I think we should find the way to send a message to new head men for FDA about
Theralase.
Any smart people on this board?