RE:Pre-BTD(and BTD) Time-Line has been respected...
Here are 2 proofs of the ever-pushed BTD submission:
August '23:
https://theralase.com/theralase-releases-2q2023-interim-financial-statements/
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 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 late 3Q2023 / early 4Q2023 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 4Q2023.
December '23:
https://www.paidpromotionalmessages.com/companies/news/1036380/theralase-technologies-ceo-roger-dumoulin-white-talks-phase-ii-clinical-bladder-cancer-trial-progress-with-fda-1036380.html
We had a meeting with the FDA in July 2023. We're working on that clinical data. Hopefully, we're in a position to reapply to the FDA with a pre-BTD in the first quarter of 2024. Once we pass muster, and they think it looks good and give us the thumbs up, then we'll supply a formal BTD.