Theralase Technologies Inc. V.TLT

Has TLT applied for BTD or not?

[gojotv!]

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.

[Oilminerdeluxe]

No, they have not. Yet. They are working on it. Slow process. Try to enjoy the painful wait :-)

[Vikingstock]

You could not read the august 29th press release to get the answer to your question and plan going forward?

[Eoganacht]

"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

[StevenBirch]

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.

[99942Apophis]

In my way of thinking your assumption is correct. Once the next pre-BTD submission has been deemed "good to go" then I expect the actual BTD will be just part of the formality for the approval.  Since we don't know exactly when the last Pre-BTD  was received by Theralase we also don't know if a new Pre-BTD is at the beginning of alteration to conform or nearing its

[Rumpl3StiltSkin]

looking good to me...