Ifor one am looking forward to this news... Because we are now at 18 patients with preliminary data available in the Phase 2 study, and 2 patients from Phase 1 will be included in the data set...
And that's what we need to apply for "Breakthrough Designation" with the FDA...
If the news was bad, we could wait until 25 or more patients (anywhere up to 125) had data available... so...
(From the website)
"To date, 18 patients have been enrolled and treated in Study II.
Fast Track Designation (“FTD”) was granted by the US Food and Drug Administration (“FDA”) to Theralase® in November 2020. In order to potentially qualify for Breakthrough Therapy Designation (“BTD”) the Company has been advised by the FDA, to provide clinical assessment data for the primary, secondary and tertiary objective for approximately 20-25 patients treated at the therapeutic dose level."
There's no reason to believe that this delay is from tabulating financials... IMO, all signs are pointing to very welcome news on Monday.