25 patients is the Magic Number"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.”"
Im hopeful they will get the next 10 patients "early 2021", therefore soon. Maybe an update on enrolment and more clarity on 1st 14 patients or now 9 remaining? They need to get these next 10 enrolled ASAP and continue to enroll even more with the aim of not just BTD, but Accelerated FDA Approval shortly after if data is there. All IMO