Once the sites are open there is a screening period-28 days. -
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!