Theralase Technologies Inc. V.TLT

RE:Timeline to Accelerated Approval

[Rumpl3StiltSkin]

Eoganacht wrote: In the July 28, 2018 BTV segment on Theralase Dr. Jewett said:

"We now move to a phase 2 study which will be designed to achieve evidence that this works in patients. Assuming that this phase 2 is positive and we eradicate this disease in a significant proportion of those patients then there is a pretty clear route to arriving at regulatory approval and we've recently had a guidance from the FDA which very clearly states the type of patient we need to treat and the endpoints, which are that their cancer is effectively eradicated and that this is sustained for a period of a year. ...... Assuming that we achieve what we're setting out to, many solid cancers are going to be treatable with this technology by modulating the light wavelength and different deliveries of the photosensitizers. There are many other opportunities here."

 

https://b-tv.com/theralase-technologies-feature-ep-329/

What was meant by "a significant proportion of patients" was made specific in the November 29, 2019 news release:

 

"Potential for accelerated FDA approval. If the Company is able to duplicate the efficacy results observed in the Phase Ib NMIBC clinical study (67% Complete Response) at an interim analysis when approximately 20 to 25 patients have been enrolled and treated, Theralase plans to submit the interim analysis to the FDA to review the results, with a focus on obtaining accelerated approval for market commercialization of the Company’s ACT treatment."         

In the Nov 23, 2020 news release where fast track designation from the FDA was announced:
 

"FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes."                             

Significant efficacy clinical outcome for patients was defined by the FDA per Dr. Jewett as that their cancer is effectively eradicated and that this is sustained for a period of a year.

The 25th patient will recieve their 90 day  assessment before the end of 2021.

Nice Eoga!

I think the likleyhood now is we match or improve on that 67% CR number, for the early CRs. I also think we eventually blow away the durable CR%. :-)