Replies to post #45620 on Vivos Inc (RDGL)

[Boot Hill]

HERE IS WHY APPROVAL WILL HAPPEN NEXT TIME:

AMIC has specific guidance from the FDA.

From the June 24th PR

In the correspondence from the FDA, the FDA requested additional data be generated to evaluate the safety and effectiveness of the Y-90 RadioGel(TM) device and provided a framework for submission of a new direct de novo. As part of this process, AMIC is working with its partners to establish protocols for preclinical animal studies as suggested by the FDA. AMIC anticipates using the Pre-Submission process to meet with the FDA in the 4th quarter to review the draft protocols for the preclinical studies and to generate additional feedback in support of a new direct de novo filing seeking reclassification as a Class II device and accordingly, marketing clearance.