RE:RE:End of Q3From May 30th 2024:
"The Company plans to resubmit the pre-BTD submission to the FDA in 2Q2024/3Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company will compile a BTD submission for review by the FDA in support of the grant of a BTD approval."
In trying to connect the invisible ink dots: This stated timeline means they have until the end of Sept 2024 just to submit the pre-BTD to the FDA. Since they can't account for when the pre-BTD will actually be submitted, and how long the FDA will take to review it, and/or what they might additional ask for (or not), and then how long it'll take to compile the officical BTD package for submission after that... I don't think they can say. Which is why they didn't give the timeline specificallty for BTD. Too many variables IMO. But from the above, it does seem like a safer bet that BTD approval isn't likely until 1Q 2025. Especially since FDA has 60 days to review and respond to the official BTD submission if I recall correctly.