RE:RE:Good NewsIt is great that TLT continues to reference the 3 treated with full dose in Ph1b, particularly since P5 & 6 were CR at 18 months and probably still are CR although no recent data reported on them. The Ph1b full dose patients do not count toward the first 25 required in StudyII for FDA consideration of BTD. However, the fact that TLT continues to reference them in recent nr's has me hopeful that they will form part of the
discussion with FDA as great examples of 'enduring CR's', They are both well past 3 years since their
single treatment.
"....achieving its next milestone of enrolling and treating twenty-five patients in early 2021. Once completed, Theralase® plans to submit the clinical assessment data on the first twenty-five patients treated in Study II to the FDA for consideration of Break Through Designation (“BTD”) status.” Johnandrose22 wrote: Shaun Shirazi, PhD..”It is exciting to see Theralase clear another hurdle...and move one step closer to achieving its next milestone of enrolling and treating twenty five patients in early 2021”.
Reading Dr. Shirazi’s words gives me increasing confidence that “early 2021” is understood as the first half of this year, ie the end of this month. I anticipate the company sharing that it has reached its next milestone at the AGM.
John