That’s not how the Sprint process works - the company has to request the meetings with the intention of resolving specific topics. If the FDA states that they have not provided enough information on a certain topic or asks questions that Vivos does not have the data to back up, it is up to Vivos to obtain that data and reschedule another round of Sprint meetings to discuss it. The FDA does not engage Vivos, it is the other way around. The onus is on the company to utilize the preference awarded to them with the BDD.
Again, stop the nonsense. FDA doesn't add meetings. All these meetings are solely at the request of MK (after receiving FDA comments on a submission) again trying to get out of giving FDA the things they've already told him they need in IDE application to consider Radiogel for human trials. That's how pre-sub program works.
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