Vivos has clearly integrated regulatory feedback into its clinical trial design. The SEC filing explicitly states that FDA input was incorporated into the trial protocol—covering critical aspects such as the transportation of RadioGel®—ensuring that the exact device intended for approval is rigorously tested rather than a diluted version.
Far from a "bait and switch," the company has implemented a methodical, step-by-step approach. Approvals were secured from multiple regulatory bodies in India, including the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO). They finalized the Clinical Trial Protocol with input from both Mayo Clinic study designs and FDA pre-submission discussions, confirming that the process adheres to the stringent standards required for testing the device as approved.
Moreover, the extensive logistical preparations—ranging from liability insurance and radioactive material licensing to international shipping protocols and contingency plans for the Yttrium-90-based product—underscore the company's commitment to operational excellence.
It's also important to address the rhetoric sometimes used in these discussions. Accusing someone of lying in a SEC filing is a serious allegation that can have legal ramifications, potentially amounting to libel if not substantiated by clear evidence. SEC filings are legal documents subject to rigorous review and oversight, and any discrepancies are typically addressed through established regulatory processes. Baseless or unverified allegations could expose the accuser to legal challenges, diverting focus from substantive discussion.
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