RE:RE:Possible Approval Timelineenriquesuave 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.