RE:RE:RE:RE:Wow! Well said Eoganacht & StevenB....
It would be nice to know how bladder volume has been generally calculated in other trials utilizing intravesical chemotherapy, & did TLT follow the standard...? If not, I would think an explanation is warranted as to why & who... We have a miracle compound that is underachieving not because of error by compound, but because of human error/oversight. At least the error has been addressed (hopefully adequately) & we still have the opportunity to go 12 for 12 CR at 1 yr if "all" are allowed to undergo a second treatment.
As for the definition of a clinical trial, I guess I hold it to a much higher standard. A trial of this magnitude (everything riding on "one" indication) backed by such a high level of scientific/medical expertise in an FDA IND-approved Ph 2 should "not" be compromised like it has imo. I don't care how big the company is. A failure/weakness due to an inherent weakness of a drug/treatment, low accrual, or other factors out of our control is acceptable. A failure in screening protocol (avoidable human error) at this stage is much harder to swallow. Botch me once, shame on science. Botch me twice, shame on the scientist.
As for the pandemic, there is NO EXCUSE to not enroll new patients from a safety/healthcare standpoint, especially in Canada!! A handful of deaths/day by Covid & we're still having this discussion...So, when Canada has a "surge" to a "dozen" deaths/day, what happens then? This trial being set back potentially a full year is an outrage & major insult to anyone with intelligence. Someone has got us by the ba!!s & won't let go...wonder who that may be. Elective procedures are full-steam ahead (even in much of the US) & a high-risk cancer patient has to wait...gimme a break said the wise man.
No more excuses...get this trial up & running! Just calling it like it is...Have to thank the holy man we have TLD 1433, Sherri & an RP without the fee. Now time for another shot of whiskey...ugh.