RE:RE:Has TLT applied for BTD or not?Can we assume that "once the pre-BTD submission has been accepted by the FDA" that granting of the BTD is practically a formality? They say the actual BTD submission is "for review" but at that point what is there to review? It would seem with all these hoops that it would be hard to criticize the company but I've been here long enough to not be surprised by too much.
Eoganacht wrote: "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." gojotv! wrote: I can't seem to get a straight answer.
And if not, why?
This company is falling far behind of their timelines.
Never a good sign.