Theralink Technologies Inc (THER)

[BooDog]

Fast may be an option once phase 2 kicks off. I believe they'll get the orphan status first. I'm not sure if they've filed for the status in Mexico or the U.S. yet.

As for the design...

As submitted, the Phase 2 clinical protocol will randomly enroll 120 early stage prostate cancer patients with 40 patients on standard active surveillance and 80 patients receiving ProscaVax. The patients' PSAs and yearly biopsies will be monitored for disease progression. The follow-up of the patients will be for two years. The investigators are Dr. Rupal Bhatt, Dr. Glenn Bubley and Dr. David Einstein at Beth Israel Deaconess Medical Center of Harvard Medical School. Early clinical research of ProscaVax, including a Phase 1 Clinical Trial that recently completed enrollment in PSA progressing prostate cancer in hormone-naïve and hormone-independent patients, has shown ProscaVax to be well tolerated with a strong safety profile. Data from late-stage patients further shows signs of efficacy with respect to an increased immune response and slowing tumor progression.

"This is a major step in our goal to provide a safe and effective option to more than 160,000 men that are diagnosed with prostate cancer each year in the U.S.," said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "There is never an easy point to initiate therapy in prostate cancer, but the decision to intervene at disease presentation can be especially troublesome due to the undesirable side effects that can result from today's standards of care. Our clinical research to date suggests that ProscaVax will be able to deliver a clinically meaningful therapeutic effect for these patients without any significant toxicities. This would be a significant advancement in patient care and improvement in the quality of life of prostate cancer patients."

https://finance.yahoo.com/news/protocol-submitted-fda-phase-2-123000165.html

We anticipate that the trial will expand the results that we found in our Phase 1 clinical trial in a different patient population. We also hope to develop our other proprietary technologies, such as the paclitaxel-albumin conjugate with regard to which we plan to file an orphan drug indication within the next two years.

https://www.sec.gov/Archives/edgar/data/1362703/000149315217010614/form10q.htm

I hope to have quite a position built by the time this really gains traction.