RE:RE:RE:RE:RE:PP and BTD which one will come first?November 29th 2023 :
The Company plans to resubmit the pre-BTD submission to the FDA in early 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 in 1Q2024.
One day we wiil have it. GL