FDA Risk Mitigation Pre-Submission Strategy

The main risk which is associated with just launching a solution, either direct-to-consumer or B2B, it doesn't really matter, is the fact that you might get burned out with the FDA if you just launch a solution and then all of a sudden you are knocking on their doors and saying, okay, please clear it now. And the main milestone, baby step to mitigate this risk is a pre-submission in which you notify, ask the FDA for an approval to just launch a non-medical solution. Again, in our case, It's basically a definition or an output definition, rather than saying, okay, we see an effective treatment, we can actually state, okay, we see an overall compounded physiological change as a proxy for efficacy decision support.