Thursday, March 25, 2021 9:17:00 AM
Here is more. Evidently the FDA expects IPIX may have pharmaceutical sales, a regulated product, or operations in fields regulated by the FDA.
"HHS Supplemental Standards of Ethical Conduct formally defines SRO as “an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA." See 5 C.F.R. § 5501.101(c)(2)."
Another step along the path. The FDA ia aware of Brilacidin for Covid19 and is watching its clinical trial and development.
GLTA,
Farrell
https://www.fda.gov/about-fda/ethics/significantly-regulated-organizations-sros
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