RE:RE:RE:RE:RE:Does CG0070 have better efficacy than Ruvidar PDT? Completely agree Eoganacht! Either the FDA BTD status which will give us our deserved recognition or a deal with Big Pharma who has done their DD. Both would be a grand slam! Ruvidar PDT would be the only One and Done ( up to 3 ) treatments to offer a durable CR status for a significant number of patients. All other treatments require many more treatments to achieve a CR status and many treatments just to maintain that CR status. Are these CR's pseudo CRs? Meaning do they need constant treatment just to keep cancer in check, or has the cancer been entirely eradicated and immune response enough to rid patients of cancer entirely? These are the things that the FDA and Urology community will look at for comparison in order to establish a Gold Standard. IMO There are many good options coming out, but IMO Ruvidar still stands out as 1st line Gold Standard overall. Time will tell. We need that BTD and a good licensing agreement eventually to really get that recognition we deserve as well as funds needed to advance on as many indications as possible.
Eoganacht wrote: I disagree.
I don't think anyone is "over the moon" with "the endless instillation" model. There has never been a choice between that "model" and something else. The goal is to save patients' bladders and researchers are all shooting for the highest possible efficacy along with the fewest and least severe side effects. It just so happens that the best treatments they have been able to come up with so far involve multiple dosing, and, at least in the case of Keytruda, serious side effects..
Until now.
Theralase is
pioneering a new kind of bladder-sparing therapy which only requires a limited number of treatments and appears to be as good or better than competing treatments in terms of efficacy, durability of response and safety.
Do you know of any other such treatments? I
don't think there are any. And I think
that's what's holding us back. Our treatment is something new and it sounds too good to be true. No one is going to take the word of a "Mickey Mouse" trial sponsor (your gratuitous and demeaning description - not mine) that they - and they alone - have come up with and are advancing a paradigm shifting cancer treatment. It sounds ridiculous.
Our data will not be taken seriously until
the FDA assesses our BTD application and renders their verdict on the the viability of Ruvidar PDT as a treatment.
When we finally get the nod from the FDA I think the main reaction from the urologist community (who I sincerely believe have the best interests of their patients at heart) will be - "Holy sh*t ! Look at this !"
Benedictus wrote: DJDawg wrote: It would be great if the application process really highlighted how disappointing some drugs are when you get further out from end of instillations. It would be great if they set a new priority of durable treatment after instillations are over as that is a different ballgame altogether.
While I agree completely, so far the establishment has spoken and they appear to be over the moon with the endless instillation model since over time it will generate more $ per patient. It's really only proactive patients assessing all treatment options regardless of their doctor's favored optionsand bean counting insurers that could steer attention toward the ruvidar protocol. Stating the obvious here but it's absolutely imperative for the commercial success of this ruvidar that Theralase partner with a deep pocketed company with distribution/marketing heft that wants to take up the task of forcing a protocol re-think on this indication. If they cannot get a credible partner, ruvidar could be the better protocol and still languish with paltry commercial sales due to a medical system that steers patients to their favored "lease your life" protocol.