RE:RE:RE:RE:RE:Upside to CREoganacht wrote: In my opinion this will have no effect on the timeline. But it might improve the chance of attaining a CR for the patients in the trial who have not yet reached 450 days. I don't see why the FDA would change what they are looking for in a BCG-unresponsive NMIBC treatment based on changes Theralase has chosen to make to the protocol of their trial.
N0taP00p wrote: So Eoga and Enrique, what does this all mean to the timeline. How much more time are you thinking if this, all of a sudden, needs to be part of a BTD application? Another 6 months, a year? Trying to decide hold vs re-buy given it's almost time to make tax decisions
enriquesuave wrote: I agree, The PI will be able to decide if a patient needs 2 more treatments and also the timing of those treatments. So a patient who is NR at first assessment at 90 days may get retreated right away and maybe a 3rd treatment 6- 8 weeks later? This would be the ideal in order to give it another go at eradicating the CIS Tumors and boosting the immune response pretty much like a vaccine. IMHO The FDA and HC probably see incredible potential and want to maximize the efficacy. So do we and Big Pharma partners! Let's go!
Eoganacht wrote: I wonder....There were 13 patients who were NR from the get go who have reached 450 days. How many of those 13 might have experienced a CR if they were eligible for up to 3 more treatments?
All of the first 12 undertreated may have ended up getting 2 full treatments.
In the swimmers plot there are 24 NR red dots at 450 days. They can't all be patients with UUTC. If even a few of them would have ended up CR after more treatments what might our 450 day durable CR numbers look like now?
The good news is that there are 38 more patients (if we stop at 100) who could benefit from this new optimization.
Donein25 wrote: Imagine what the CR % will look like when we start retreating patients who have a recurrence, and they then show a CR at their next scheduled follow up?
Hard to imagine that the Amendment wasn't granted due in part to a strong consensus that the treatment is so effective that an additional 1 or 2 treatments will likely also benefit those patients who were NRs.
Agreed. I also view this amendment more in the context of expected commercialization. The exemplary safety profile is underlying this decision to refine the maintenance treatment protocol not just as a means of improving CR data for the study but in terms of refining the inevitable commercial protocol and achieving even better outcomes for patients.
Now we just have to hope with such compelling CR data and an even better optimitized protocol CSS patient recruitment can grow beyond 2 or 3 new patients per quarter. This recruitment pace is frustratingly slow!