Post by
Eoganacht on Jun 13, 2021 7:57pm
From the April Newsletter
"Theralase® is currently focused on working with its Canadian and US-based CSSs to enroll and provide the primary Study Treatment for up to 7 additional patients in 2Q2021 for a total of 20 to 25 patients enrolled and treated in Study II. Theralase® plans to compile up to the 90, 180, 270, 360 and 450 day assessment data (urine cytology and cystoscopy) for these patients with the intent of submitting this interim data to the FDA for consideration of Breakthrough Designation (“BTD”) approval."
Comment by
Johnandrose22 on Jun 13, 2021 8:14pm
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
Comment by
Eoganacht on Jun 13, 2021 8:34pm
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.
Comment by
Yajne on Jun 13, 2021 9:05pm
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.
Comment by
Eoganacht on Jun 13, 2021 9:47pm
Theralase 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.
Comment by
Pandora on Jun 13, 2021 10:50pm
I just find it humorous to think that 450 days would be covered by the term "Fast Track" and am glad we are not on the standard track -- or, heaven forbid, a slow track.
Comment by
CancerSlayer on Jun 13, 2021 10:54pm
From a little shareholder perspective, I'd consider 450 days for 25 patients to not even be on a slow track...more like derailed ; ).
Comment by
Eoganacht on Jun 14, 2021 12:19am
Hi CancerSlayer - the way I understood that is that they will compile the data for each of the 25 at each of those points of time up to either the point where their cancer recurs or they reach the 450 day assessment - this would be why they used the words "up to"
Comment by
Pandora on Jun 14, 2021 12:44am
That would be more along my thought process although I am not sure how you would express it. I am thinking along the lines of a "rolling" data set. i.e. each 90 days the data is provided for all patients pertaining to their particular status. If that makes sense or maybe it's quite obvious.