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Ann: Atomo receives TGA approval for COVID19 antibody test, page-109

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28/09/20

10:45

Post #: 47671549
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Originally posted by wongomery: ↑

Hi all
Found this.

SRO for web posting, August 2020.
xlsxhttps://www.fda.gov/media/142332/downloadInc CANADA XLY TSX VENTURE EXCHANGE 743638850 ATOMO DIAGNOSTICS LIMITED AUSTRALIA

Atomo has been added onto FDA's SRO (significantly regulated organization) list in its August 2020.

https://www.fda.gov/about-fda/ethics/listing-significantly-regulated-organizations-sro

Which companies are included on the SRO List?
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.

Questions -
Happy to stand correct - are we waiting for TGA as well as FDA outcome for ATOMO some time soon?
What can one take from this SRO list from FDA??

Expand

23 September 2020: U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

Look like they are progressing through the application. Hope we have an FDA outcome soon

AT1 Price at posting: 37.0¢ Sentiment: Buy Disclosure: Held
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