RE:RE:RE:RE:RE:RE:So TLT announces breakthrough cancer tech on regular basisOne thing that is done in Phase I trials is to determine the safety, toxicity and some measure of efficacy of the dosing...dosing can be adjusted in Phase I trials...a red and inflammed bladder after one month might not be too concerning, but after three months it would concern me as a researcher...I'd need to know if it was due to the dosing either with the compound or the laser light, and I would look to determine that cause before moving forward.
A red and inflammed bladder probably means annoyingly frequent urges to void the bladder which can wreak havoc with one's lifestyle and sleep cycles...that's a relatively minor side effect compared to being free of cancer progression, but it might mean a dosing adjustment is indicated before proceeding further in the trial...questions to be answered include should an adjustment be made to the PDC, or to the light intensity and/or duration, or some combination of both?
So, making the determination of the cause for the red and inflammed bladder in patient 4, as well as the source of the reseeding giving rise to the observed recurrences in those affected, these are trial steps that take time to analyze.
(Note: the mucosa layer is the same from the catch basin in the kidney thru the ureters and throughout the bladder. NMIBC can occur anywhere in that mucosa. If it occurs in the UUT, it can be carried down to the bladder itself where it can cause recurrence according to the trial design--"from any cause". The Ta level indications have been very resistant to treatments in the past, whether by chemotherapy or by radiation, so those are usually given a wait and see. It's the T1 level indications that are more receptive to treatment and are what is usually treated in NMIBC.)
To the investigative determinations noted above, add a possible tighter prescreening criteria to eliminate UUTUC-prone patients, possible dosing adjustment, possible consideration of the minimum dose 3 patients being retreated (remember, they were specifically excluded from retreatment in the original trial design), and finding and screening patients 5 thru 9...that makes for a lot of decisions and the associated paperwork to go with any filings for changes to the protocol...it can take weeks for each iteration of back and forth mailings/submittals and considerations before approval of any single change to the trial design is received...recruitment might have been suspended while the paperwork was being done because in most screenings the patient data is only usable within a certain time frame, or it has to be retaken...patients once thought to be qualified might have to be rescreened or replaced, especially if their NMIBC has progressed to become MIBC.
And besides, we were told not to expect any interim NRs in re patients 5 thru 9...just my NSHO.