The FDA cannot turn down such treatment No matter how we see it, even in a worse case scenario, even with only 35% TR @450-days, we would get BTD (and even full approval) as this treatment can spare bladder, especially that our treatment:
- has no counter indications or patients discrimination like gene therapies, immunotherapies,
- we could keep treating like ImmunityBio or BCG or gene therapy,
- we have high safety profile,
- we could combo,
- we’re no dependent to BCG, etc ….
So enough options and more than decent efficacy % (even in a worse case scenario) that the FDA cannot hide away from patients this new alternative.
And we had more than our share of « red » @90-days lately, so I assume odds could rebalance toward a minimum 40% TR%.
With so many options/benefits/worse case durable efficacy % scenario, would one of you would render unavailable this treatment option to people facing bladder removal??? I don't think so. The FDA will ask itself the same question and will come to obvious conclusion and make this treatment available to the patients as it is one more tool that can make a difference in 40%+ of the cases.