RE:RE:RE:RE:RE:Once the sites are open there is a screening period-28 days.greaterfoolFred wrote: Eoganacht wrote: "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.”"
- May 19 2020 news release
Just checking the math; 67% of 25 would be 17, leaving an allowance of 8 non CRs. I think we already have 8 or more. So how do we get to 67% in the first 25?
CancerSlayer wrote: Floatinketucky wrote:
Also.... One more thing... Keep in mind the company has acess to the FDA for communication. And Shawn the CEO is about as reserved on predictions as anyone I have seen. So when he repeatly says we now need 9 for the 25 patient Breakthrough status expect that he know what he is talking about!
I agree that 9 more (at most) could get us to a BTD. Fortunately, the threshold for granting a BTD is more about promise & is less stringent than that for an accelerated approval. Considering the strength of TLT's science, that "25 patient" FDA guidance shouldn't have to change despite the previous removal of patients. I am hopeful the CR should be sufficiently promising even if the removed patients are included in the BTD decision-making by the FDA. I suspect the FDA could also base their BTD decision strictly on the 20 patients who were appropriately not removed, or simply await treatment of an additional 5, replacing those who were removed. There are other patient iterations, but I should refocus ; )
As for an accelerated approval (AA) decision, more strict statistical guidelines are obviously followed by the FDA. As opposed to a BTD decision, an AA decision is certainly based on more than just promise....JMO. Good luck...
Sorry - I put this commentinthe middle of the box by mistake, here iit is at the end where it should be;
Just checking the math; 67% of 25 would be 17, leaving an allowance of 8 non CRs. I think we already have 8 or more. So how do we get to 67% in the first 25?