RE:RE:RE:RE:RE:RE:RE:2 weeks: It’s all it took for Merck to get AA I think all of us including myself were confused with Research Capital. AKA Mackie, Theralase's main go to for financing and analyst coverage dropped its target from $1.20 to .80 and pushed out revenues to 2026. Most of us are looking for a $10-100 target. If TLT was able to get AA it would allow them to generate some revenues. Why the anaylst pushed them back to 2026 seemed odd, then I looked at how TLT phased their NR for interim financial in Q2 and Q3. For some reason, maybe known by the Research Capital ppl TLT talks about AA in their Q2 interim financials, but that seems to be missing in their Q3 financials. Several posters on this board suggested revenue in January 2023 based on AA, I believe TLT alluded to January 2023 revenues as well. Why would one of the ppl closer to TLT's management push out revenues to 2026? While I am hoping to see both BTD and AA in the near future, I wouldn't be surpised is AA is off the table, which may put a lot of us in AA. :)
August 2022:
- Break Through Designation Update. In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD to represent a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and assessed, who demonstrate significant safety and efficacy clinical outcomes.
November 2022:
2)
Break Through Designation Update. In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSS’s availability to complete all required assessments and biostatistical review and analysis.