If the numbers keep climbing and ICUs start to overflow, there has to be a discussion at the FDA about EUA for Brilacidin. It would be unethical to not explore this path especially after the Hydroxychloquine experiment. That had little evidence, all anecdotal stuff really. Brilacidin has had some strong performance at the RBLs and speaking as a tax payer, the next logical step is grant approval and EUA.
This is from one of the FAQs at the FDA:
Q. What is an Emergency Use Authorization?
In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits FDA to issue emergency use authorizations (EUAs) to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat or prevent a serious disease or condition in a public health emergency.
Products authorized for use in this way may not be approved by FDA for any use, or they may be approved for other uses but not for the emergency use. FDA decides whether the use of the product is likely to more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks. This authorization is reserved for emergency situations and is NOT the same as FDA approval or licensure.
https://www.fda.gov/media/136784/download
This is from one of the FAQs at the FDA:
Q. What is an Emergency Use Authorization?
In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits FDA to issue emergency use authorizations (EUAs) to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat or prevent a serious disease or condition in a public health emergency.
Products authorized for use in this way may not be approved by FDA for any use, or they may be approved for other uses but not for the emergency use. FDA decides whether the use of the product is likely to more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks. This authorization is reserved for emergency situations and is NOT the same as FDA approval or licensure.
https://www.fda.gov/media/136784/download
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***On 02/26/2016 at 8:33 am Scottsmith admited to posting under 5 aliases but his post was subsequently deleted. I have a screen shot and will email it to anyone interested.
