RE:RE:RE:News? Gerbl, i believe i am the only one who tells the truth. Maybe you should re-read the NR's. In regards to Bencro's comments, he seems to be fixated on this Bunge guy who hasn't posted here in years. Must keep him up at night as he seems to spend more time talking bashing someone who isn't on stockhouse than adding anything meaning. Bencro/SF is the one who also stated Dec BTD and Jan revenues, he actually raved about it until the timeline changed. for the past 9 years he has an ever changing opinion... These are my words, these are from TLT and SF... which part is wrong?
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 day assessment for 25 patients, expected in
4Q2022, subject to the Clinical Study Sites (“CSS”) availability to complete all required assessments.
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In February, 2022 Theralase
® reported that PHAC had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.
These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase® COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022.
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Comment by
ScienceFirston Apr 27, 2022 9:11am RE:4 Keys To Winning FDA Breakthrough Therapy Designation
The hiring of Dr. Vera Madzarevic on Oct. 25, 2021 confirms that TLT is in discussions with the FDA for the Breakthrough designation. Her hiring was justified due to the workload and importance of this designation to TLT's future.
Oct. 2021 (hiring of Dr. Vera Madzarevic) to Dec. 2022 (Theralase projected FDA decision on the Breakthrough designation) makes sense.
“You have to allocate these resources early to submit the application, because this particular application involves review from senior level members of the FDA.” That review, she says, is an intense one that takes place within 60 days as the application works its way through the review center, where reviewers make recommendations to the application before it’s sent to a senior FDA manager at the policy council. The council then opines on its decision before returning its review findings to the applicant.
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Comment by
ScienceFirston Apr 30, 2022 10:20am 
128 Views
Post# 34644700
RE:RE:RE:RE:RE:RE:RE:BTD timeline...
In line with what I always posted; 25 patients @450-days
1. 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 followed-up, who demonstrate significant safety and efficacy clinical outcomes.
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 day assessment for 25 patients, expected in 4Q2022, subject to the Clinical Study Sites (“CSS”) availability to complete all required assessments.
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Post by
ScienceFirston May 04, 2022 12:37pm 184 Views
Post# 34655391
Commercialization phase - Jan 2023 to December 2025
P. 12 of the most recent presentation shows the that expect Breakthrough designation a bit before 2022 year's end. Like around late November.
They also expect "commercialization phase" starting Jan. 2023, through December 2025.
Given that FDA and HC approval is due late 2025, my take is that they expect to have Breakthrough AND
Accelerated Approval (AA) early 2023 (i.e Januray 2023). This "commercialization phase" would bring
revenues, whether from AA designation or from an upfront payment related to a jv (a jv deal that would already be agreed upon). There's no other reasons that could explain this "commercialization phase". That's the only rational explanation. So valuation is coming soon.