RE:RE:RE:Be nice to c the new sites & patient enrollments 10 patients early 2021 for 25 for Breakthrough Designation
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."
greaterfoolFred wrote: biggerr wrote: I agree, it's been a very slow pace so far - we'll be celebrating 3 years next month since the 2 patients got cured of their bladder cancer in the Phase I and since then no real progress. Hopefully things will speed up now with the 6th US site added, all they need is 9 more patients treated - how hard could that be, they could do it in one week for gawd sake
I think we need to get real with the numbers. FDA isn't going to let them leave the five with failed treatments out of the calculations like was done in the last quarterly report. They will have to include all of the first 12 or none of them. I think that our real 25 starts with patient 13, after the protocol was corrected. So we really need 37. C'est la vie.
Good luck all.
And as an aside, on a topic in another thread, sometimes a B12 supplement can cut down the nightly number of bathroom trips.