The SP & TR patients.I agree with the investors on this board...watching the SP going down is a very unpleasant feeling, but the entities pushing the SP down are using only a very very small number of shares to do so. This is a very good proof that there is absolutely nothing wrong with TLT treatment, as the vast majority of investors are holding on to their TLT shares(they know better).
Instead of worrying about the SP, ask yourself what is going nicely in the phase11 trial.One thing that is going very nicely, is that each time TLT publish an update the CR at 450 is increasing, and will continue to do so in the next update.
TR(CR+IR).
Another data that is doing extremely well is the TR(CR+IR).
First...An IR patient is a patient that is still in the phase11 trial and continue to be evaluated by TLT.
For these IR patients, radical cystectomy has been
delayed. Question???
Will the FDA take into consideration
delay in radical cystectomy when evaluating the
efficacy of TLT treatment, after all some IR patients have avoided radical cystectomy for more than 450 days(patients 9&10, in the 2023 Swimmer Plot)?
The answer could be in this FDA link.
https://fda.gov/media/101468/download Page 6, paragraph 4&5.
In short the FDA said" The goal of therapy in patients with BCG-Unresponsive NMIBC, is to avoid cystectomy...
delay in radical cystectony is considered a direct patient benefit...sponsor(TLT) should collect these data(IR patients) which may provide supportive evidence of
effectiveness". The above could explain why TLT always include the TR(CR+IR) in their update.
TR(CR+IR) is the
total number of patients that have achieved the FDA goal of avoiding cystectomy in the phase11 trial.
In the last update (April 2023) the TR(CR+IR) is...
TR(CR+IR) 90 days....180 days....270 days....360days.....450days
65% 84% 78% 52% 83%
Note1) These are nice numbers if you consider that before starting the phase11 trial, 100% of these patients were guaranteed to lose their bladder.
Note2) For the FDA, BTD is to fill an
unmet need, as we speak the FDA has no viable treatment to offer to these patients(except radical cystectomy), having said that, with these kind of patients +45%TR is impressive.
To conclude.
- In due time the SP will go were it need to go.
-For now...Don't lose sleep over the SP.