Biostax Corp (BTAX)

[TASBES0101]

This is from a 3/17 press release. The third step includes "the Kenyan Ministry of Health, and/or any of several global healthcare funding agencies, to issue a purchase order of Lodonal for indigenous patients with HIV/AIDS". After this, IMUN and Omaera would finalize their agreement. I'm assuming Omaera's ability to commit to $31,000,000 in sales contracts is based on funding from one of these agencies.


https://www.immunetherapeutics.com/2017/03/immune-therapeutics-signs-distribution-mou-for-lodonal-in-kenya-company-plans-to-open-kenya-for-lodonal-in-2017/

Commercializing Lodonal in Kenya

There are three steps remaining to commercialize Lodonal in Kenya. First, is for regulators in the Dominican Republic, where the Company formulates and manufactures its Lodonal, to issue it a Certificate of Pharmaceutical Product (“COPP”) authorizing it to export Lodonal to Kenya.

Second, is for the Company to submit a New Drug Application (“NDA”) to Kenyan regulators and for that to be accepted – by which Lodonal then becomes a “registered” drug and receives a registration number (This is also known as the Marketing Authorization). A full Lodonal preclinical and clinical study program, including four clinical efficacy trials with more than 500 HIV/AIDS, 89 patients for cancer, and 250 patients for autoimmune disease, supports the NDA filing. In recent Phase 3 clinical studies, patient outcomes exceeded end-points by a substantial margin.

Third, will be for the Kenyan Ministry of Health, and/or any of several global healthcare funding agencies, to issue a purchase order of Lodonal for indigenous patients with HIV/AIDS. At that time, Immune Therapeutics, GB Pharma, and Omaera will finalize an exclusive, definitive agreement based on the volume and pricing of those purchase orders and commence sales, marketing, and distribution.

The Company plans to reach commercialization for Lodonal in Kenya in 2017. It is following the same strategy in Nigeria, where the process is further ahead, having already received the COPP, and is anticipated to reach commercialization by mid-2017.