RE:RE:RE:Once the sites are open there is a screening period-28 days.greaterfoolFred wrote: floatinketucky wrote: floatinketucky wrote: -
Overall Study Design and Plan: Description
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada, the United States and internationally. Patients with NMIBC CIS with or without resected papillary disease (Ta, T1) that are considered BCG-Unresponsive or are intolerant to BCG therapy that meet the inclusion and exclusion criteria will be enrolled and treated. The Study will consist of 100 patients who will receive PDT employing 0. 70 mg/cm^2 (Therapeutic Dose).
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Screening Period
Patients will be qualified for Study entry by review of inclusion and exclusion criteria during the Screening Period, which will last up to 28 days.
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Follow-Up Phase
All patients enrolled and treated by the treatment procedure will be followed until the End of Study defined as completion of all required assessments after 12 months of follow-up post treatment or earlier due to early discontinuation or withdrawal of informed consent.
During the Follow-Up Phase, information on efficacy and safety will be collected. Assessments will be conducted at Day 0, 7, 30, 60, 90, 180, 187, 210, 240, 270 and 360.
- Study Drug and PDT Administration
https://www.clinicaltrials.gov/ct2/show/record/NCT03945162?term=TLD-1433&draw=2&rank=1
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Free .02 cents. The company has many sites ready to treat patients. I'm expecting faster patients treatment news now that we have also had some good screening time lapse. The time for reporting patients 15 to 16 went swiftly. I'm looking for more treatments to happen swiftly.
Also.... One more thing... Keep in mind the company has acess to the FDA for communication. And Shawn the CEO is about as reserved on predictions as anyone I have seen. So when he repeatly says we now need 9 for the 25 patient Breakthrough status expect that he know what he is talking about!
As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system (“TLC-3200”), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.
https://theralase.com/theralase-granted-fda-fast-track-designation-for-nmibc-phase-ii-clinical-study/
TLTFF- long
The is much value in this stock. Do your DD!
March 25, 2021 To date 16 patients have been treated in Study II. The Company has now launched 5 CSS’s in Canada and 6 in the US for patient enrollment and treatment under Study II clinical study guideline.
Shawn Shirazi PhD, Chief Executive Officer, Theralase®, stated, “It is exciting to see Theralase hit its target of having 6 US clinical sites on board in 1Q 2021. It is truly uplifting to be working on the details of getting patients enrolled and treated at these sites. Theralase is another step closer in achieving its next milestone of enrolling and treating 9 additional patients in early 2021 to meet the target of 25 patients for potential Breakthrough Designation.”
March 25, 2021, Theralase® Technologies Inc
https://theralase.com/theralase-launches-sixth-clinical-study-site-in-the-us-for-phase-ii-bladder-cancer-clinical-study/
Hey float, I like your optimism, and maybe if the next 9 have really good results then 25 will do. We can hope. But I don't like to see unreasonable expectations that set us up for later disappointment.
We also need to be realistic about the time required for setting up a site for first treatment. This isn't like a study of some drug where you just ship a box of pills. We have to ship out equipment, and then send a technician for set-up and training. Then patient enrolment can start. First treatment might also require a training visit. It all takes time.
if you think the first treatment requires a training session, how is it possible after treating patient 5&6 in Phase 1 did we manage to start the Phase 2 trial with gross miss treatment. As I have stated before after the huge success with patient 5&6 would you not want an "A" team to make sure the proper treatment was administered in Phase 2.