Theralase Technologies Inc. V.TLT

Timeline to Accelerated Approval

[Eoganacht]

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."         

 

It was mentioned again in the May 19 2020 news release:

Shawn Shirazi went on to say, “In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval (“FTA”) post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated.”

[Pandora]

CTI Biopharma (CTIC), the leader in this months Pinnacle Digest stock picking contest, got "Accelerated Approval" for their drug at the end of February and their share price has gone from $1.90 to $5.23

[Yajne]

Now this one is interesting to me....incredible what is being approved these days, Am I reading this one right that CTI got AA approval despite the many adverse reactions listed in their NR? Unbelievable in comparison to what TLT offers. The FDA bar appears to be very low these days, at least for some things......go TLT! The accelerated approval is based on efficacy results from the pivotal

[justus434]

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[robertshaw]

TLD1433 's pending BTD is far more important than CTIC' s AA(which might come in Mid 2025).... But because of Blowjobjoe's bosses inntensive care, we are at dirty cheap level at 0.3 $... Wtf...