RE:RE:RE:RE:RE:RE:Are You Ready?See highlight and comments below:
CancerSlayer wrote:
99942Apophis wrote: My comment here isn't meant to insult but to point out a common trait people have and thats to not include the obvious into this trial. Time lines were moved out not because the company did or didn't do something but because Covid-19 greatly affected the enrollment & treatment of patients! Regardless of the initial under dosing we are seeing one patient after another hitting CR so yes not hitting original target dates but can't blame the company for low enrollment. Why wouldn't I expect this high CR percentage to continue, optimized treatment back on track. I again see continuation of CR as a normal outcome that this treatment works very well.
Well said...& what we do know is that Dr. Madzarevic (who joined Oct. 25, 2021) had nothing to do with the original timeline. According to the Sept. 2021 company presentation, the projected BTD timeline was in the 1st half of 2022. The most recent projected timeline is now in the latter part of 2022 (per the Feb 2022 company presentation). It makes sense the timeline change may have been influenced by Covid-19, but the change could also be due in part to the fact that the company was operating under different leadership/guidance in Aug/Sept. 2021 (Dr. Shirazi followed by Mr. Trikola). Nevertheless, in the context of clinical trial timelines, such a relatively minuscule change in projections shouldn't significantly impact our sp or our progress towards approval.
Moving forward, it appears Covid-19 should be significantly less disruptive of our trials. As for patient enrollment in the US, I believe that responsibility falls on the individual trial sites (site coordinators & PIs) & the TMO (trial maintenance organization) with whom TLT signed an agreement back in July 2019. One of the advantages of signing with a TMO is to allow for more rapid enrollment/treatment. As you say, if there's any slow/low enrollment, you need to look at factors outside of TLT's purview. Good luck & hope I didn't insult anybody ; ).
I had pointed this out to many here when the sites were announced, I did some research and found that many were offering multiple other choice trials for NMIBC , and some were sponsored or backed by BIG pharma, and who do you think these US site coordinators are being influenced by when it comes to suggesting a new trial for their patients, all just IMHO of course.
Coop