RE:RE:Tidbits from today's presentationHankerchief wrote: Thanks for the info....
Wonder why there has to be a wait until Q3 2021 to start phase 1 work on GBM/NSCLC?
Would think they could hop on this now?
Eoganacht wrote: 3Q2021 - Commence Phase 1b clinical studies for GBM and NSCLC
4Q2021 - Enrol and treat 10 GBM and 10 NSCLC patients Canada
2021 - Breakthrough Designation from FDA for results of first 20 - 25 patients
Theralase has no affiliation with the study being conducted by Roswell Park and Dr. McFarland
FDA requirement for CR at 360 days is 360 days post the initial CR, not 360 days post the initial treatment. This has been done at the FDA's request and has lengthened the duration of the phase 2 study. Competing treatments such as Merck's Keytruda measured 360 day CR from the initial treatment which gives their results an advantage over Theralase as it represents a shorter duration.
No money now for another trial ... need to show some results in 1H2021, raise the SP and raise some cash in order to proceed in 3Q2021 ... salaries and overhead during the COVID shutdown apparently used up what they had set aside for additional trials, so those trials have been delayed ... options include grant money and also partnership/joint venture, but they're not in place yet.