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Re: fantomphan post# 18905

Sunday, 02/16/2020 11:36:31 AM

Sunday, February 16, 2020 11:36:31 AM

Post# of 27434
Ever since the Ebola crisis in 2014 and including the SARS outbreak in 2016 the company's strategy for outreach has included reaching out to many different organizations including the World Health Organization, the FDA, the CDC as well as government agencies such as USAMRIID and even non profit organizations and hospitals. These agencies as well as the NIH are aware of the therapy, so it's not the company's fault.

Each of these agencies has a different mission and focus, but what would bring them together in this country is this 319 process:

https://www.cdc.gov/flu/pandemic-resources/planning-preparedness/regulations-laws-during-pandemic.htm

"The HHS Secretary may, under section 319 of the PHS ActExternal determine that a disease or disorder presents a public health emergency; or that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists. Following a section 319 declaration, the Secretary can take many actions during an influenza pandemic, including making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder..."

"Section 564 of the FD&C Act (FDA), authorizes the HHS Secretary to declare an emergency justifying the emergency use authorization (EUA)External of medical countermeasures (MCMs) during public health emergencies. When an EUA is declared, the FDA Commissioner can allow either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear (CBRN) agent. For example, during the 2009 H1N1 influenza pandemic, the FDA approved the emergency use of antivirals for certain patients and health care settingsExternal."
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