RE:RE:RE:Possible Approval Timeline 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 was set to take over NMIBC/MIBC as standard of care, eventually. Until of course that news out of Europe of the 50% CR effective vaccine for NMIBC. Which should eventually get approved here and take some of this market.
wildbird1 wrote: 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 July 5,2017 there is a video by DR, Kulkarni, at the 5:20 time; Dr Kulkarni said (Quote) The FDA has more or less come out, and stated that in the phase 2 trial approximately 30% response is required, because ours second blind treatment(BCG) are so poor (End of Quote).
If TLT does get 67% or better it will be fantastic results.
enriquesuave wrote: 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 next batch of patients,that may be enough? Who know we shall see.
Eoganacht wrote: 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.