RE:RE:RE:RE:RE:Improving results yetYour concern is understood, personally for myself I only care that BTD is accomplished and approved, by no means am I brushing your concern off as it could very well happen. We more or less are all at the ability of the hired consultants hired for this task as stated in the news release, dependent on various individuals and groups generally makes it difficult to form an accurate timeline.
In mid-2023, the Company submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the Clinical Study Sites (" CSSs "), a central pathology organization, a biostatistics organization and a regulatory consulting 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 1Q2024 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.