Ann: Trading Halt, page-107

The FDA has been reviewing RAP and asking question for nearly 10 months now, ask yourself, doesn't ResAppDx assist in their own following guideline.....they might even allow for pneumonia foreign data as we all know how indecisive those 2 doctors were in the US clinical trial.


FDA may then issue an EUA for a product if FDA finds that:

• • the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;

• • based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;

• • the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition, taking into consideration the material threat posed by the agent or agents identified in a declaration by the DHS Secretary, if applicable;

• • there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition; and in the case of a determination by the Secretary of Defense regarding risk to U.S. military forces from agents other than chemical, biological, radiological and nuclear agents, that the request for emergency use is made by the Secretary of Defense.