RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:CG Oncology NMIBC data I would say give 2 treatments to all, and a 3rd for those who are still PR or NR at 9 months mark. 2nd treatment could be given perhaps even before 6 months mark if patient is PR or NR at 90 days. 3rd treatment at about 9 months. Ideally Drs should note where CIS is present in the bladder prior to trial ( I'm sure they already do) if new lesions appear as old ones disappear, then for sure a 3rd treatment should be required,as seeding of new tumors from UT or from elsewhere could be the cause, hence a 3 rd treatment would act like a booster shot where tumor is again destroyed in an attempt to stimulate immune response. Ultimately I think our drug will be combined with either checkpoint inhibitors or immune stimulating factors, especially for PR or NR patients. IMHO
99942Apophis wrote:
CancerSlayer wrote:
Well said Enrique...
This ACT not only has best in class single-agent data, but I'd also say best in class drug efficiency/mechanism of action. And the FDA simply can't ignore the fact that this ACT has demonstrated an "only in class" ability to rid cancer with only one treatment as evidenced by the two Ph 1b patients. This screams loud & clear that this tech carries unprecedented potential. All of this potential wrapped up into 1 to 2 simple outpatient treatments, or a total of no more than 2 to 3 hrs of treatment time. And the benefit of having such an efficient protocol is that you can significantly reduce risk of iatrogenic injury/side effects, problems not uncommonly seen in your more traditional treatments.
In view of the above, I would assign a new metric, "Durable Response Burden", a quality-of-life (QOL) measure that looks beyond response data alone, but also takes into account the number of treatments required to attain a desired result over a set periods of time. That desired result could be a CR, IR or stable disease. Disease-free survival, progression-free disease/survival & other metric data simply discount both treatment & patient burden, which play major roles in a patient's QOL...a metric only a patient can ultimately measure, but certainly deserves more attention. Good luck...
enriquesuave wrote:
On top of our best in class single agent data so far, the fact that this a pretty much a One and Done treatment and see you in 6 months for a maintenance should be used to push the FDA for BTD. Needs of Elderly patients must be taken into account. This option gives them freedom and much less morbidity of having weekly instillations with all of the swelling and pain and possible infections which the procedure involves. IMHO
ScienceFirst wrote:
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There has been innovations in all industries, including oncology. And this wil continue. No plot theories here. Just facts, R&D, innovations and competition.
Public Health budgets are about 50% of all Canadian provinces budgets. So huge incentives to lower them, especially with the growing population of elderly people. Ontario government that sponsored our technology that will spur medical tourism will of course push for such treatment if deemed superior.
Private insurance companies are other parties that will push for it too.
Laparoscopy, arteoscopy, 1-day surgeries, etc ... are all innovative procedures that have been integrated in the health systems. TLT has done the heavy lifting to bring PDT/PDC to bedside and mainstream thanks to a molecule with impressive attributes. It could allow big pharmas to treat way more patients in early stage instead of having too many dying because of lack of efficient treatments.
My question to our medical minded fellow posters on 2nd treatment after the trail is completed would a better option be to monitor the patients on a monthly or quarterly checkup and administer the 2nd treatment when needed. We saw in Phase1 the now famous 2 patients go 2 years Cancer Free and in this Phase2 many needed that second treatment so do you think after the trial is complete stick to current guidelines of 2nd treatment at six months or 2nd treatment as needed?