Running list - some of these overlap but can clean up later1. Most news releases and updates from the company reference ongoing work on the IV Rutherrin but use the same phrasing over and over again. "Once Rutherrin®’s Maximum Tolerated Dose (“MTD”) and hence Human Equivalent Dose (“HED”) limits have been determined
through non-Good Laboratory Practices (“GLP”) and GLP toxicology studies, Theralase®, subject to the required regulatory approvals, plans to inject Rutherrin® systemically into patients via a Phase Ib clinical study, to allow localization to various cancer cells, including Glio Blastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”) and then activate Rutherrin® with radiation with the
intent of safely and effectively destroying the cancer of interest." The repetive wording does not suggest any progress.
Question: What progress has been made towards an IND application? Is one expected this year, next year or beyond that?
2. How concrete are the recently referenced plans to expand the number of sites recruiting for the NMIBC study? For example, have the sites been determined? Have research applications been made? Have local PI's been identified.
3. What is your timeline for BTD data submission? Do you have directional feedback from the FDA that can be shared?
4. What is within your definition of commercialization and do you expect it this year?
5. What is the status of vaccine trials? Any timeline?
6. Do you have enough data to support an application for phase 1 trial of brain and lung cancer?
7. Does the HCA know you exist?