BTD soon?Excellent results...a few more patients added...and if the timelines are accurate (which is questionable after so many delays): BTD is getting close. We are almost 1/2 way through Q3, and according to the PR:
The Company plans to resubmit the pre-BTD submission to the FDA in 3Q2024 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 3Q 2024 in support of the grant of a BTD approval.
It's been a long, long journey, but maybe...just maybe...we are close to a 'breakthrough'.