Decision Diagnostics Corp (DECN)

[nonsequetor]

I believe your answer has been provided:

So as a primer you might read up on the FDA Modifications Guidance (2016) governing changes to a cleared product, and then perhaps we can have a reasoned exchange. As an expert on packaging, you know that the FDA considers a package as the most important part of what they call product labeling. Change the labeling on a cleared product without seeking a new clearance, and the product is considered adulterated -- even if nothing has been done to the original product.

If Big Box wants to have an exclusive brand, preferably their own, then the short answer to your statements is, would you rather have a product on the Big Box shelf in 2018 that is unadulterated, or have a product on Big Box shelf in 2020 after spending two years and several hundreds of thousands of dollars getting clearance for something already cleared. Or, does DECN tell Big Box to pound sand and buy what they have?