Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

Regulatory Approval Process.


Even though AXIM acquired the FDA approved 510K for these two Dry Eye Disease #PointOfCare #LateralFlowTests there is still a "regulatory approval process" (imposed by the FDA) that Barry Craig was hired to help with.


Pulled from the press release:

"Barry will be instrumental in assisting us to navigate our field study and regulatory approval process.”

Above sentence is the last sentence of the following paragraph.

“After extensive due diligence, we fully expect our supply agreement with IUL will enable us to transform the DED diagnostic testing market with the highest quality readers available and an approach that is light years ahead of industry competitors,” said John Huemoeller, CEO of AXIM Biotech. “We have the only FDA-cleared quantitative test for Dry Eye Disease and believe that it has tremendous accuracy and convenient ease of use for ophthalmologists as well as frontline optometrists. Barry will be instrumental in assisting us to navigate our field study and regulatory approval process.”