RE:RE:10 patients early 2021 for 25 for Breakthrough Designation Of course, if we have 12 month results on the first 25 patients in August 2022, based on those results we should have a very good idea what our chances for approval are going to be and the stock price will reflect that.
Eoganacht wrote: If we get the 10 additional patients by May 1, after about 15 months, in August 2022 we can apply for Breakthrough Designation and Accelerated Approval. 6 months later, by February 2023, we should have the FDA decision on whether or not we can commercialize the treatment based on results from the first 25 patients.
floatinketucky wrote: Shawn Shirazi, PhD, Chief Executive Officer, Theralase®, stated, "Each CSS Theralase launches for Study II will aid in our objective of enrolling and treating 10 patients in early 2021 to achieve a total of 25 patients for potential Breakthrough Designation Approval and approximately 75 to 100 additional patients in 2021 / 2022."