Theralase Technologies Inc. V.TLT

RE:RE:RE:Hey Roger and management!

[Oilminerdeluxe]

CancerSlayer wrote:

Oilminerdeluxe wrote: I had abrief exchange with someone recently, who should know, in regards to the pre-BTD. It was said that it's still on track for sending in during Q3. Which is now. I want to see it to believe it but it sounded like it's still scheduled for September. Although, i did not get a confirmation to my *are you absolutely sure?* remark, lol. We will see. Feels like pre.BTD is harder to achieve than actual BTD. Unless there is some additional data the FDA suddenly wants, then things might soon look exciting for real. One can hope at least.

I'm hanging in there Oilminer...It's been a long "pre-BTD" process since our first 25 patients were treated back in 2021.  A combination of the pandemic, a clinical trial optimization amendment & regulatory acceptance, data clarifiction & the need for central path lab review have added more delay than what I expected.  

It's difficult to accurately assign blame.  We received FTD back in Nov. 2020, yet the need for central path lab review wasn't reported until Oct. 2023 if my timeline is correct.  It's not clear to me if this was a "late" add-on by the FDA or not.  Whatever the case, there should be no other reason for further delay unless the Fed finds yet another reason, which I believe we've run out of.  

The approved trial optimization protocol does include the option (at the discretion of the PI) for up to 2 additional maintenance treatments for any recurrence noted at any scheduled assessment (up to 450 days).  It's nice that patients now have this optionality & it seems highly unlikely this would be an additional FDA barrier at this point in the study.

In my view, the big "F" in FTD certainly didn't mean fast...perhaps they meant finicky or fastidious?  JMO.

Long indeed. I hope they do actually get it done this time. And tell us. The waiting will be so much easier then.