RE:RE:RE:TLT is working with FDA on BTDIs there a clear target date for BTD? After, unfortunately, and at this point, embarrassingly, being in this stock for over a decade, my reading of each release looks for the nuance in the language of statements released by this company.
"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."
My skeptical reading of this sentence is that IF the FDA accepts the Pre-BTD submission, the company will compile a submission for review in 4Q2023. That does not mean BTD approval is in 4Q2023; it only indicates the company will do an actual compilation of a BTD submission, which may or may not be submitted in 42023. I do not read that to mean BTD approval should be anticipated in 4Q2023. Hopefully, that compilation will be submitted in 4Q2023 and not drag out into the first half 2024.
So, when it was previously mentioned that BTD submission could be in "days," that was probably too optimistic. Pre-BTD submission still needs work to be ready for acceptance and comment. It is a small company with limited resources and no history of going through the approval process, so it shouldn't be a surprise they don't have a perfect package for submission on the first attempt. The learning curve for them must be immense. Hopefully, the company can find some new money and resources necessary to finish this and try for BTD designation. This could get worse Without that BTD, possible AA designation, and the potential for revenue or JV partnership.