RE:RE:RE:Difficult-to-value$-TLT...CancerSlayer wrote:
thadeush wrote: Excellent points. I'm no health expert, but I'd imagine the patients TLT is currently treating after other treatments did not cure/help, from wildbird1's points 3, 4, and 5, are already immunocompromised because they are exhausted from the side effects of previous treatment regimens. Yet T:T is still getting excellent results. Imagine the results TLT will get when they finally have the chance to be the first line of treatment and can make use of a patient's more robust immune response. Methinks it will improve their percentages significantly.
If TLT's higher efficacy & safety rates pan out at completion of the study, I'd also expect there will be some off-label use of TLT's ACT as a first line option, especially considering our protocol requires only two treatments.
One would expect a push for earlier use of our ACT when you consider the high failure rate of BCG in high-risk NMIBC (recurrence & significant 5 year risk of progression) & the fact that roughly 60+% of patients with NMIBC don't even receive adequate BCG therapy due to various factors, including adverse events, side effects, poor compliance/too many treatments, limited BCG supply, cost, etc....these factors become even more of an issue when treating higher-risk NMIBC (i.e. CIS disease), which can require significantly more treatments/bladder instillations (up to a total of 30+ treatments over several years). And if/once our ACT is approved & the word gets out, I wouldn't be surprised to see such off-label use continue to increase over time due to both increasing doctor & "patient" demand.
If all goes well, I also expect our ACT will be involved in various 1st/2nd-line combo trials (w/BCG & others) to validate its benefits beyond being a stand-alone option in the most severe/refractory cases.
Forgot to mention...in addition to entering future combo trials, I anticipate there will eventually be much broader investigation of our ACT in the form of more extensive randomized clinical trials, comparing our ACT as a potential first-line option against the standard of care....but we can leave that expense to our future partner or Pharma ; ). All of the above JMHO.