Cytodyn Inc (CYDY)

[JPG77]

Great Find!!!

And here's the part that I think says it all:

"A summary of the trial results was released on February 14, 2020 and showed that 3 out of 4 patients had zero circulating tumor cells. The fourth patient had high levels and after just two weekly treatments showed a significant reduction. Only two of the patients that were measured for tumor shrinkage shortly after treatment. Both showed tumor reduction, but the patient with the more pronounced disease, taking the higher dosage, showed 50% tumor reduction at 3 weeks and another 55% tumor reduction after an additional 3 weeks for a cumulative tumor reduction of approximately 80% after 6 weeks. Anecdotally this formerly bedridden patient was able to resume normal activity within a very short period of time allowing for a much better quality of life.

Results like these appear to meet the requirements of Breakthrough Therapy Designation (BTD). In order to get BTD the drug must be targeting a life threatening disease and have clinical evidence in human trials that it may demonstrate a clear advantage over available therapy. CELLSEARCH is an FDA approved test to measure CTCs and has been mainly used since its approval in 2004 as a prognostic tool. There are few if any clinical trials using CTC’s as a surrogate endpoint because until leronlimab, metastasis simply was not targeted. Three major studies in breast, prostate, and colon cancer show the clinical benefit of reducing CTCs under 5 and keeping them there. The incredible safety profile of leronlimab in 840 HIV patients is another testament and reason why it will not be difficult to award BTD to leronlimab. Right now many patients who have cancer metastasis have no treatment options and will die if they don’t get treatment. It is unfathomable to think that leronlimab, the perfect definition of a breakthrough therapy drug will not get the designation. The true debate will be centered on whether or not the FDA is willing to grant conditional approval before the required regulatory response due date on March 14th."