RE:RE:RE:RE:From the April NewsletterTheralase announced it had been granted Fast Track Designation on Nov. 23, 2020, almost 7 months ago. It issued the newsletter advising us of their intention to submit 450 day data for the first 25 patients, on April 27, just 47 days ago. I emailed Theralase for clarification of their statement in the newsletter. I'll post their reply if I get one.
Yajne wrote: I'm having trouble accepting that they'll be required to wait until P25 has hit 360 or even 450 days. Hopefully TLT is taking advantage of their ongoing communication access gained with Fast Track Approval to share data at earlier milestones and maybe they don't have to wait until P25 hits 360.
Eoganacht wrote: Except that Theralase announced in the newsletter it would be compiling 450 day data on the first 20 - 25 patients. 450 days is exactly 90 days after 360 days so it sounds to me like Theralase is saying the submission will occur 360 days after the first 90 day assessment of patient 25, or 450 days after the initial treatment of patient 25.
Johnandrose22 wrote: I would think that Phase 1 patients 5 and 6 would cover the long range of this interim data, ie 450 days. Perhaps that is why the company highlighted their extraordinary CRs in consistent news releases.
Good news continues to build.
John