Jul. 10 at 5:55 PM
$NXL
Correction:
Nexalin's HALO™ Clarity is a medical device. As a result, it follows the FDA's medical device regulatory pathway.
Disregard Phase 1, 2, 3 as it’s not a drug. Thank you for the user catching the error.
Next steps MUST be; a) Successful completion of the pivotal trial.
b) Submission of the FDA De Novo application.
c) FDA clearance to market HALO™ Clarity.