Axim Biotechnologies Inc (AXIM)

[TexasMarvL]

Bottom line is Verséa has resources that understand how to interact with the FDA.

Verséa knows how to submit CLIA Waivers and have them approved. It has only been 3+ months since manufacturing started at Auer Precision. At some point Verséa Ophthalmics will have a priority to help AXIM with the CLIA Waiver Application process. Something tells me there is a schedule that needs to be followed.

What needs to happen BEFORE CLIA Waivers are approved??


A few things I can think of are listed:

Auer Precision will need to ramp up manufacturing to meet the explosion of new customers.

AXIM and Verséa Ophthalmics will need hundreds or thousands of the new test readers that are manufactured in Spain.

Verséa Ophthalmics would need to ramp up their support teams. Warehouse, Sales, Accounting, Customer support.

I'm sure there are other considerations.

Blue, thanks for sharing the CLIA Waiver information from Verséa Health!!

AXIM and Verséa Ophthalmics are following a plan. A lot of things need to happen BEFORE turning on the flood of new orders.

At least the FDA is moving faster when CLIA Waivers are submitted.



Not investment advice.

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Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS

Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485

#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316