RE:RE:RE:RE:RE:BTD timeline...Hi Pandora,
What I meant by the '25th patient" is the 25th patient treated in phase 2. Not including the 3 phase 1 patients and not differentiating between optimized or unoptimized - just the first 25 patients treated in phase 2. We know that the first 12 patients treated in phase 2 were undertreated so data for the first 25 patients will underestimate the true efficacy of the treatment.
Nonetheless - just suppose we have to rely on the results of the first 25 patients for AA. The Nov 29 quarterly report reports that
14 out of 33 patients were CR at 90 days. The total of 33 includes
3 patients from phase 1 and
the first 30 treated in phase 2. If we exclude the phase 1 patients we have
12 out of 30 patients with a CR at 90 days which is
40% CR. But 7 of the 30 had not yet reached 90 days and were recorded as
pending. If we ignore 5 of the pending we are back to a total of
25. If patients 24 and 25 were CR at 90 days, which I think is likely, we arrive at
14 out of 25 patients CR at 90 days - which is
56%!
If just 7 of those14 patients maintain their CR at 360 days after their initial 90 day CR this equals
28% CR at 360 days, which is
10% better than what Keytruda achieved before being approved by the FDA.
And this will have been achieved with
12 out of 25 patients undertreated. If the FDA looks beyond the results for the first 25 at the much better results that have been accumulated from patient 13 onward, then it's difficult to see how Theralase doen't get accelerated approval.
It explains Theralase's confidence in projecting commercialization at the beginning of 2023.
Pandora wrote: Sorry Eoganacht but I still get confused over quotes regarding numbers of patients. I never know if we are talking only about "optimized" treatment patients of Phase 2 or "all" patients and if the Phase 1b patients are ever included as part of "all" or not.
Your quote:
"The 25th patient received the 90 day assessment in December 2021. So before the end of 2022 Theralase will be able to submit 360 day data on the first 25 patients to the FDA."
Your reference here to the '25th patient' and to 'the first 25 patients' -- does that, or does that not, include the 12 patients that did not receive the correct dosages i.e. 'non-optimized' at the start of phase 2?
Below is your post from April 18 referring to 23 patients and the 82% CR:(again I am not sure which 23 patients are addressed here -- maybe it's just me, but I feel others may not be completely sure either) Are they Patients #1 - 23 in Study II or are they Patients #13 - 36 in Study II or a mix? I believe the "total" number that had been referenced was 38 but I believe that total number included Patients #5 & 6 from Study 1b:
One more look at the new 90 day optimized data
I changed the percentages to patient counts for the recent 90 day numbers for the:
23 patients enrolled and treated in Study II who received an optimized primary study treatment
CR = 12
PR = 4
Pending = 3
NR = 4
Potential CR = 82%
In the last newsletter there were 18 post-Aug 20 2020 optimized patients
CR = 8
PR = 2
Pending = 7
NR = 1
Potential CR = 94.4%
In the period between the two news releases 7 patients reached 90 days and 5 more patients were treated for a total of 12 patients. Of these 12 patients there were:
CR = 4
PR = 2
Pending = 3
NR = 3
Potential CR = 75%
Out of these 12 patients 3 patients (25%) were NR. The results of just these 3 patients accounts for the drop in 90 day potential CR. We will probably never know what happened with these 3 probably very sick and elderly patients but given where we are in the trial it will likely have little overall effect. If you flip a coin 12 times you won't likely get 6 heads and 6 tails. You might get 4 tails and 8 heads. But if you fip a coin 100 times it will be much closer to 50% heads and 50% tails. If those 3 patients had been CR or PR we would have a 90 day potential CR of 96% and the sp would have reached new heights IMHO. But this isn't the first time Theralase's sp has taken an unexpected and unwarranted hit.