Humanigen Inc (fka HGENQ)

[Knuckle Sandwich]

Highlighted sections from HGEN Company Website under Lenzilumab Development Page as well as the National Health Security Strategy 2019-2022.

I believe that The National Stockpile portion of Lenzilumab's EUA & Subsequent BLA are a very important part of future sales in maintaining stockpile reserves.

With data from the BET and our ongoing Phase III study, including the component being conducted in Brazil, we expect to have data from approximately 500 hospitalized COVID-19 patients.

We believe that the ongoing Phase III study has the potential to serve as a basis for lenzilumab to receive EUA from FDA. The FDA’s authority to grant EUAs emanates from the Pandemic and All Hazards Preparedness Reauthorization Act of 2013, which authorizes and enhances FDA’s ability to support emergency preparedness and foster the development and availability of medicinal products (drugs, biologics and medical devices) for use in emergencies. EUAs permit marketing and use of medicinal products in response to declared, public health emergencies before the products are approved by FDA under the Food, Drug, & Cosmetic Act. FDA, however, holds authority to limit, restrict or condition the amount of promotional activity that accompanies EUA-approved medicinal products. An EUA, if issued in respect of lenzilumab, would be temporary; if an EUA were issued, that would not take the place of our need to complete the formal BLA submission, review and approval process.

https://www.humanigen.com/lenz-development




National Health Security Strategy 2019-2022

2. Protect the nation from the health effects of emerging and pandemic infectious diseases and
chemical, biological, radiological, and nuclear (CBRN) threats.
Areas of focus for this objective include, but are not limited to:
• Continuing efforts to improve early detection of emerging and potential pandemic
infectious diseases;
• Rapidly identifying, developing, producing, and making available safe, effective medical
countermeasures (MCMs)ii

ii Medical Countermeasures are pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and
nonpharmaceutical products, such as ventilators, diagnostic tests, PPE, and patient decontamination materials,
that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency.
;
• Maintaining the capacity to produce enough vaccines and other necessary MCMs to
provide protection from pandemic influenza and CBRN agents that represent a strategic
health security threat to the nation; and
• Supporting SLTT authorities’ efforts to stock, and rapidly obtain, distribute, dispense,
administer, and monitor the safety of MCMs.

https://www.phe.gov/Preparedness/planning/authority/nhss/Documents/NHSS-Strategy-508.pdf