Replies to post #2618 on Theralase Technologies Inc (TLTFF)

[123414]

Here is Dr. Kulkarni talking about the first trial.
"For the most part I"m running the clinical trials at this institution. One of those clinical trials is the theralase 1433 1b.  So to speak to what Dr. Jewett said, this is a safety trial.

16:04

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Here is the official title of the 1b safety trial.

Study Type:
Interventional
Study Design:
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title:
A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients With Non-muscle Invasive Bladder Cancer at High Risk of Progression Who Are Refractory to Bacillus Calmette-Guerin Therapy and Who Are Medically Unfit for/Refuse Cystectomy
https://clinicaltrials.gov/ct2/show/NCT03053635?term=1433&rank=1
 

[Geo2014]

Phase 2 and Phase 3 ARE clinical trials for capturing safety and efficacy data and they ARE required. I asked the question because there was a week-long debate on here about what Phase 1 encompasses. Phase 1 trials are first and foremost to capture safety, tolerability and dosing data. There is NO primary efficacy data being captured. The clinical team will review secondary efficacy measures but again, they are not looking at efficacy as a primary end-point. I was just trying to make my point from my previous posts during the debate.