RE:RE:Questions 3 and 4Pandora,
The regulators didn't change anything here. Theralase botched the treatment of their first 12 patients (under Dr. Jewett), which resulted in the need to adjust their sample size and the numbers of successful treatments needed to obtain the results necessary to address the size of market to which the results would apply. Anyone with any statistical sampling experience knows this.
The charts can be found on the FDA clinical trials site. I looked at them back in 2014 when I first became interested in the company, but I can't point you to them today. Of note, however, is the fact that the Study II results are significantly less than the small number reults from the Phase 1b trial. If they were still having success with 2 of every 3 patients, then I suspect we'd be further advanced by now, but our numbers haven't been thst good.
Regards,
tdon1229