Theralase Technologies Inc. V.TLT

Possible Approval Timeline

[Eoganacht]

From the news release:

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.

If Theralase can apply for accelerated approval with one year results for 20 to 25 patients, priority review would mean approval within 6 months of the FDA receiving the application (shaving 4 months off regular review)

It's possible FDA approval may come around 1.5 years after the treatment of patient 25.

[enriquesuave]

I have noticed that they did not mention a specific number percentage of CR for Accelerated approval.  Just says " significant safety and efficacy clinical outcomes "  perhaps the FDA is up to speed on the under treatment of the first 12, and if the next 13 show significant efficacy then Accelerated approval is in the bag.  So maybe if 67% or better  is achieved in

[Eoganacht]

Hopefully that will be enough. But we may do much better than that.

[wildbird1]

enriquesuave you are right they did not mention the percentage...But unless I did miss something, the fast track treatment for now is for replacing the 50 years old BCG treatment for BCG unresponsive patients, because after a certain number of treatments, BCG doesn't work anymore and is very toxic. TLT treatment is non toxic and can be repeated as many time as necessary. In the PressRelease

[Rumpl3StiltSkin]

WB, the only thing here I think you got wrong is that the FT is NOT, yet anyway, set to replace BCG. TLT's solution is only for late stage patients that have failed BCG. BCG is very expensive over time because of so many treatments, even if it were in abundance and cheaper TLT's methods would eventually be competetive because of how few the treatments could be, one in some cases. So TLT

[Longholder99]

Theralase will be a subsidiary at that point. No way big pharm is gonna let retailers ride this wave to the top. We will make out nicely in the buyout. If these patients start adding up to 20 or 25 with CR, the Big Pharms that are paying attention will know what is happening way before we do and they will execute. Because that is what they do and it is why they will have the money required to do