RE:RE:Investor Presentation [12-2024] Nobody yet knows what the FDA is lookifor here. No matter what they have to complete trial and get as many sites needed to do so. If Accelerated FDA approval is granted , they will still need to complete trial for full approval as well as do a confirmatory trial. As per FDA guidelines completion of trial ( extra 25 or so patients) can sometimes serve as a confirmatory trial if I remember correctly. So full approval should be 2026/2027 however AA can come before. IMHO
TommyNickels wrote: Clearly the FDA wants the study completed. They haven't recruited 4 new sites for no reason. Roger likely was gambling that 75 would be good enough. As wr have been saying, Theralase is not sufficiently bankrolled. 4 new sites and no money for new patients.
They have to get the money and then recruit the patients. Will 25 more patients be completed by end of Q2? Doubtful, hence the 2027 deadline.
If you are lucky, the next 25 are treated by the end of Q3 / early Q4.