Theralase Technologies Inc. V.TLT

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

[floatinketucky]

1. 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).

2. 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.

3. 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.

4. 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!
 

[floatinketucky]

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

[greaterfoolFred]

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

[O12009]

  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.

[greaterfoolFred]

The whole point of a phase 2 trial is to test the treatment in different locations with different medical teams.  After any required training, they follow a prescribed procedure to carry out the treatment.  The trial is a test of the drug, the equipment, the training and the procedure to make sure that the treatment will work in the real world.  Medical people are very good at

[floatinketucky]

I agree Fred. Lets consider this.  ------------------------------------------------------ Theralase Granted FDA Fast Track Designation for NMIBC Phase II Clinical Study Toronto, Ontario –November 23, 2020, 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

[CancerSlayer]

Floatinketucky wrote:   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!  I agree that 9 more (at most) could get us to a BTD

[Eoganacht]

"Shawn Shirazi went on to say, “In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for

[greaterfoolFred]

[greaterfoolFred]

Sorry - I put this commentinthe middle of the box by mistake, here iit is at the end where it should be; Just checking the math; 67% of 25 would be 17, leaving an allowance of 8 non CRs.  I think we already have 8 or more.  So how do we get to 67% in the first 25?

[CancerSlayer]

  Anyone correct me if I'm wrong...but my math tells me that there were 6 non CRs of a total of 14 that were reported in the quarterly...four were reported to have been removed based on the "old/flawed" definition of treatment eligibility.  And the others didn't get a first treatment that was optimized.

[CancerSlayer]

"Anyone correct me if I'm wrong...but my math tells me that there were 6 non CRs of a total of 14 that were reported in the quarterly...four were reported to have been removed based on the "old/flawed" definition of treatment eligibility.  And the others didn't get a first treatment that was optimized." Non CRs = non-responders....of the 6 non-responders

[CancerSlayer]

  Furthermore, if all nine patients reported at the 180 day assessment remain or become CR (includes the two TBDs, two partial responders & the one non-responder) & the "optimized" patients #15 to 25 also achieve CR, our CR rate would still be "80%" (20/25)...& that includes the 4 patients initially removed those who were under-treated.  If you exclude

[CancerSlayer]

Clarification (hate getting old): "Furthermore, if all nine patients reported at the 180 day assessment remain or become CR (includes the two TBDs, two partial responders & the one non-responder) & the "optimized" patients #15 to 25 also achieve CR, our CR rate would still be "80%" (20/25)...& that includes the 4 patients initially removed and those who