Vivos Inc (RDGL)

[kayak_wench]

I am not at all surprised to see short-term traders sell given there wasn't a big surge in price with PR. I am sure their plan is to get out then ignore this until a week or two before the 30 day clock is up. The cool thing is that we could get a quick approval. That would be awesome, and it would likely catch day traders off guard. Whether, and if so how quickly, a pre-30 day approval happens seems to be about the quality of the submission. Vivos must have nailed that given how long and closely they worked with FDA. Then throw in the BDD which means it goes into the top of the FDA's que.

From ChatGPT, but others posted similar information they took from FDA site:

The FDA can approve an Investigational Device Exemption (IDE) submission before the end of the 30-day review period. The FDA is required to review and make a decision on an IDE submission within 30 days, but if they complete their review and are satisfied with the submission earlier, they can approve it before the 30-day period ends. It's important for the sponsor to ensure that all the necessary information and documentation are complete and accurately presented to facilitate a swift review.