RE:Pre-BTD expectations in August vs October The Market Herald article says:
"Over the next six months the company is working on a pre-breakthrough designation approval for the FDA and will focus on enrolling and treating and additional 37 patients in the clinical study." But the article is a somewhat misleading summary of the video interview by Coreena Robertson at the top of the page:
https://themarketherald.ca/theralase-is-raising-up-to-5-3m-to-complete-bladder-cancer-study-2023-11-06/ If you listen to the actual interview it's clear that Roger was not creating any new timeline, he was merely answering the question that was asked:
Coreena Robertson: "And can you tell us what the company expects to accomplish over the next 6 to 12 months?"
Roger Dumoulin-White: "Absolutely. Over the next 6 months, we're currently working on what's called a pre-breakthrough Designation approval from the FDA. This will add validity to the technology and the progress of it. Over the next 12 to 14 months we're looking to enrol and treat all the patients in the clinical study. So we have 63, we're looking for 100, we're looking to treat another 37. So once we get them in to the study then we can follow them up and we're looking to complete the study in 2-2026."
It was Ms. Robertson who brought up
the next 6 to 12 months, not Roger. He merely tried to answer the question in the terms it was being asked. He simply stated what they are working on now without any comment about when either the pre-BTD or BTD will be submitted.
He seems to be taking great pains to answer her question exactly, so he talks about 12-14 months for the completion of the trial so his answer will fit the previously announced estimated end of the treatment phase of the trial by the end of 2024. (There are still 2 months in 2023 after all!)
450 days after the last patient is treated that patient should receive their 450 day assessment and we will have reached the end of the trial, just as Roger says:
"...
So once we get them in to the study then we can follow them up and we're looking to complete the study in 2-2026" 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.
N0taP00p