Tuesday, March 19, 2019 11:54:28 AM
Sam,
The FDA is going after all companies that claim to be a solution for the "Opiod Crisis". We make that claim because we have actual evidence as an opiate replacement and have gotten literally thousands of people off of their opiate drugs with Nyloxin.
The warning letter requires us to respond and make some changes to our marketing materials and our website. We're working on our response now.
Just as an FYI: ALL drug companies get a warning letter every now and then. It's the FDA's job as the industry watchdog. The letter lays out their potential concerns. The company then either argues their points or takes corrective action or both. When I worked at Rexall, we got warning letters at least once a month.
I hope that this information is helpful,
Rik
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