Replies to post #171534 on Vivos Inc (RDGL)

[den4]

1- SC8 is a proven serial liar ( see my posts debunking your fake news)

2- I did see a shit ton of medical news websites shared the news and most importantly the company itself said itself is the most reputable source..
FDA generally cannot publicly disclose whether a sponsor has submitted a Breakthrough Device designation request for a device or whether the FDA has granted or denied the request, unless the company decides to make that information available to the public.

3- it is common knowledge that all data needs to be sent to the FDA and the company is very close to submit the requested data as the genotoxicity testing is highly likely finished by now and are doing the analyzing part now. MK has sent shit ton of data already contrary to your assumptions..

Conclusion: CNN SC8 Fake news didn’t see the BDD announcement on CNN, so he has a hard time to believing in it..