Pretty good chance that next weeks deal is about this - from PR on 3/22:
Additionally, the Company has entered negotiations with Pro Wave Ad Product ("PWA"), a Bulgarian Company, to supply the raw material for PWA's Contract in India for the production of a spray modulating the immune system under U.S. Patent No. 8,309,072 owned by Zhabilov Trust. This contract is valued at more than $50 million to PWA. This is the only approved use of this technology as a nutraceutical. The FDA issued a nutraceutical number to Harry Zhabilov on October 12, 2018. The first delivery under this agreement with PWA is expected to be in late spring 2021. The value to the Company is yet to be determined.
The spray product is a nutraceutical application, separate from the ITV-1 treatment that successfully completed Phase 3 clinical trials on August 7, 2014, with the Final Report being issued in November of 2016 by Assoc. Prof. Ivaylo Elenkov, MD, Chief researcher at the Specialized Hospital for Active Treatment of Infectious and Parasite Diseases. This report and the associated clinical trials were conducted under Bulgarian Drug Administration (BDA) guidelines. With Bulgaria joining the EMA in April of 2019, the BDA can no longer issue permits for mass use for the HIV/AIDS virus. Under the Company's new business arrangement with International Medical Partners, Ltd. (IMBL), new clinical trials are being planned and scheduled with Clinical Design, a Clinical Research Organization (CRO) in Bulgaria. The Company is finalizing negotiations with a Contract Manufacturer, also located in Bulgaria, for the production of the ITV-1 Immunotherapy treatment. The new clinical trials for the Patented and licensed ITV-1 treatment under the EMA guidelines will be submitted upon completion. When the EMA permit for mass use is issued, the Company plans to pursue Federal Drug Administration (FDA) approval under the Mutual Recognition Agreement between the FDA and EMA.
As a result of the necessity to perform Clinical trials under the EMA guidelines, the agreements with IMMB BG, which were in default, have been cancelled and superseded by the new agreements with IMBL and PAW.
Harry Zhabilov, CSO, stated, "With our new partners at IMBL, the CRO and the CMO, all located in Bulgaria, and all experienced in the EMA Permitting process, the next steps in bringing our Immunotherapy Treatment for HIV/AIDS and hepatitis C viruses to a point of approval by the EMA is on the right path. The contract being negotiated with PAW is expected to produce meaningful revenue generated from our technology."
