RE:RE:RE:RE:RE:RE:RE:RE:RE:New Press Release - Theralase(R) Announces Brokered LIFE FinancingOkay, I had some time today and went through some of the old NR. I know people don't do much DD or research here, so let me help out. This is why the promoters are here because they know they can just keep telling a make believe story and always try to convince you to buy, like they are always buying. Lololololololol. Anyways, just look at there last few NRs. There is no mention of a BTD date anymore. No more Q3 or Q4 or 1Q2024. Knowing this company every little nuances have to be looked under a microscope. These BTD dates were given once during the Aug 29 2Q financials. The only new dates given were by RDW, maybe this was one of the disclosure requirement for LIFE financing. Even if pre BTD is approved, they will still need to compile more data for the official BTD submission for approval. Do people really think that will happen in a few months. Lolololololol. Just my 0.02 cents. I could be completely wrong on the timelines but so far I have been batting pretty good. Cheers.
https://stockhouse.com/news/press-releases/2023/08/29/theralase-release-s-2q2023-interim-financial-statements
The Company has submitted a pre-BTD submission to the FDA and based on the FDA's feedback, the Company is currently working with the CSSs, a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in late 3Q2023 / early 4Q2023 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 4Q2023.
After that, there was no mention of any dates anymore on any of the NRs and updates. The only new timeline I saw was given was by RWD..
https://stockhouse.com/news/press-releases/2023/10/16/theralase-r-provides-update-on-bladder-cancer-clinical-study
Theralase® hopes to complete patient enrollment with accompanying administration of the primary Study II Treatment by year end 2024. If successful, this will allow the Company the ability to complete assessment of the primary, secondary and tertiary endpoints of these patients by 2026.