RE:RE:RE:RE:Financials are out on Sedar
enriquesuave wrote: Yes that's Q1 and results look amazing to me. So far 7 patients out of 22 are CR at both 3 months and maintained at 6 months.( that's 2 from PH1 and 5 from PH2).. Also 2 PR or partial responses are still PR at 6 months ( indicating they have a clean cystoscope exam and only urine cytology is positive), which is also amazing as there is a good chance that they have UUTUC rather than bladder cancer and may eventually be counted as CR. 4 patients are still pending 90 and 180 days so numbers can go up. Given that 5 patients were wrongly dropped from trial early on given severe underdosing of 1st 12 patients, results look pretty awesome I would say. We see high efficacy and a durable efficacy. None of the competitors show the same durable efficacy from 3 months to 6 months all drop from about 45% to 30% and drop further to 15-24% at 12 months and even further at 450 days. This awesomeness should be confirmed after we see data from pending patients IMO.
Nice summary Enrique...
My eyes are now laser-focused on optimized patients only at this point...the protocol recommended for community practice. I would add that under "optimized" treatment conditions (including patients 5 & 6 from Ph 1), we are currently looking at the following post 90 day assessments:
CR = 4 patients
No R = 1 patient (? patient death due to unassociated cause)
Pending = 3 patients
Based on the above, we're already looking at a 50% CR (under optimized conditions) before any knowledge of the results of the pending patients. Regarding the two PRs, they could very well qualify as CRs (as you stated) with the demonstration of upper tract disease...& by chance if there's no evidence of upper tract disease, the two PRs could very well become CRs post the 2nd "optimized" treatment. Such a scenario would boost our CR to 60% with results of 3 patients pending.
And yes, the durability of response demonstrated thus far is very reassuring to say the least & bodes well for future approval. I wouldn't be surprised to see 50+% durable responses after 1 yr...JMHO. Fortunately, medicine is equally an art as it is a science, & it is constantly evolving/improving. If all continues to go well with our durable response rates, I'd imagine for those patients who happen to relapse in the future or longer term, there would certainly be sound evidence to support an additional treatment (one/two dose) at that point in time, especially in view of the life-changing/devastating alternative.
The FDA's focus has certainly broadened in recent years for highly unmet needs. While improving overall survival still plays a significant role in determining commercialization, the ability to offer quality of life with more efficacious & practical options is no less paramount. GLTA.