Replies to post #5489 on Theralink Technologies Inc (THER)

[tr1205]

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."

[Tanker12]

Approval for what? full scale production? Here is why OBMP is on the SRO List. We are on it because we are company that is producing a drug. Below is the definition of how you get on the SRO list.

Listing of Significantly Regulated Organizations (SRO)

A publicly traded company, US or foreign stock exchange, is added to the SRO List if it meets either of the following criteria:

It is 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;
An organization that does not have a record of sales of FDA-regulated products 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.
For a monthly listing of all added and removed Significantly Regulated Organizations please click the following link: Monthly Added & Removed Significantly Regulated Organizations (SRO)