RE:Pre-BTD expectations in August vs October N0taP00p wrote: In the Q2 NR of August, they said the following about pre-BTD: The company has submitted a prebreakthrough designation submission to the FDA, and based on the FDAs feedback, the company is currently working with the CSSs, a biostatistical organization and a regulatory organization to update the prebreakthrough designation with clinical data clarifications identified by the FDA. The company plans to resubmit the prebreakthrough designation submission to the FDA in late third quarter 2023/early fourth quarter 2023 for FDA review of these clarifications. Once the prebreakthrough designation 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 fourth quarter 2023. No mention of any special FDA requests for Central lab validation, 18 month CR follow up data, or need for any phase2 optimization. This was an all-FDA based NR
Then; two months later, they released the new optimization NR, which mixed in HCA and FDA requirements (see RDW quote ) in such a way that it is hard to tell if pre-BTD is delayed. People here said the solicitation email they got for funding said end of Q4. But the Market Herald article says pre-BTD submission could be 6 months. The company should clarify this in their Q3 MD&A. That's a must do.
My guess is that the FDA (which granted them phase 1b approval and then an FTD in 2020) did NOT suddenly ask for central lab verification. So this should not be a gate to pre-BTD submission to the FDA. The optimization to add more maintenance treatments is for remaining phase 2 patients and they seem to want to align the HCA approval with the FDA. Still does'nt gate pre-BTD submission to the FDA. That leaves the post-450 day survival data which seems to be an HCA request but now added to the pre-BTD FDA application, that too with central lab validation. This is the one that is confounding. How much extra time is this additional validation adding and did the FDA ask for this. Why not take care of HCA mandated central lab validation later?
The BOD should dust off their governance framework before issuing the next MD&A.
The Market Herald article says that over the next 6 months TLT is working on the pre-BTD and treating an additonal 37 patients to meet their study 2 goals. Don't let that 6 months figure throw you. pre-BTD might already be submitted. And depending on the FDA desk it lands on could be granted in a few business days. Then TLT wll have blue sky ahead to start the 60day FDA clock on BTD approval...