The word UPDATE...Sometime a single word make's a lot's of difference.
In the Aug 29,2023 press release, TLT said " 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 organisation and a regulatory organisation to update the pre-BTD with clinical data clarifications identified by the FDA."
The word update, seem to indicate that there is absolutely nothing wrong with the pre-BTD submission.
-Nothing wrong with safety & side effects...
-Nothing wrong with the manufacturing of TLD-1433...
-Nothing wrong with efficacy...
-Nothing wrong with the treatment process...
The FDA simply want the latest updated data available on the phase11 trial(maybe the optimized data).
If it is just an update on data, TLT could be closer than we think to the BTD approval.