Thoughts on 4th patient as we waitPossible assumption here on my part is we will not get any more news on new
Patients going through the procedure until the 30 day CT scan is done for the fourth patient.
In my opinion with The outstanding results from the first 3 patients and the great success with the
Low dosage making them reoccurrence free at 30 days is very significant and may lead
To extra caution exercised because of the therapeutic dose being used on the 4
th patient. The therapeutic dose being double of the first dose. They might think That the therapeutic dose is excessive because of the low dose success (100%), and just needs to be verified that no harm comes to the 4
th patient or others waiting inline. It may be prudent, cautionary, but may be needed. They need to prove that there is no damage done to the tissue of the bladder before continuing. Just my opinion. Then when all clear im sure rthey will all get the proceedure in short order after that.
This is listed in the Primary Outcome Measure’s of the link below.
https://clinicaltrials.gov/ct2/show/study/NCT03053635?show_desc=Y “Primary Outcome Measures: · Assessment of Safety: Evaluation of the safety of TLD1433 will be assessed with the incidence and severity of Adverse Effects [ Time Frame: Up to the completion of follow-up phase (180 days) ] Hematology, blood chemistry, and urinalysis for safety purposes will be performed at days 1, 3, 30, 60, 90 and 180 as well as at the time of premature discontinuation. Troponin testing will only be performed at day 1, 3, and 30. CT scan will be performed at Day 30 and Day 180 to identify possible tissue reaction to PDT.”