tem 8.01 Other Events. On June 3, 2020, Generex
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On June 3, 2020, Generex Biotechnology Corporation (“Generex”) submitted its application for funding to the Coalition for Epidemic Preparedness Innovations (“CEPI”) under CEPI’s “calls for proposals” for projects to develop vaccine candidates and support clinical trials involving vaccine candidates. Generex’s application plan provides CEPI with a comprehensive approach that includes all of the necessary Programmatic, Regulatory, Development, Clinical, and CMC activities required for the successful licensure of Generex’s novel, complete Ii-Key SARS-COV-2 Vaccine. In addition, Generex included the necessary work for large scale surveillance studies and commercial scale manufacturing to ensure readiness to respond to the public health needs. Assuming funding authorization by 15 June 2020, our plan will allow our vaccine to enter the clinic in August/September and have pivotal efficacy trials starting in the late Fall of 2020; Generex submitted a total budget of over $2,000,000,000.
CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible