Endonovo Therapeutics Inc (ENDV)

[Biotech_Tradez]

I called you out for being a Paid Cheerleader and you denied it, while having received 3,500,000 shares of stock.

I also called you out for spreading lies and misinforming people about this contraption. Among the lies is that the device works and is "FDA Approved." This device is FDA Cleared not Approved and in recent studies it, specifically the Rhodes study, was basically the same as a placebo.

This device has not been shown to be effective in large human studies and was cleared by the FDA based on a resubmitted 510(k) arguing that the device was "substantial equivalent" to a device that was already legally marketed before the FDA started regulating medical devices.

You are either ignorant and severely misinformed or you are spreading lies. I have on numerous occasions stated that this device is not FDA Approved yet you keep spreading the lie that it is despite the evidence to the contrary. If the contraption were FDA approved then it would have the clinical trials to show its effectiveness and it would have sales.

The main difference between FDA clearance and FDA approval is the level of regulatory scrutiny and the types of evidence required:

FDA approval
A higher standard that involves extensive research, clinical trials, and documentation of safety, efficacy, and manufacturing processes. The FDA decides that the benefits of the product outweigh the known risks.

FDA clearance
A lower standard that involves demonstrating that the product is "substantially equivalent" to another similar legally marketed device that has already been approved. Specific testing on FDA cleared products may be absent or minimal.

The FDA uses two distinct regulatory procedures for approval and clearance:

FDA-approved
Manufacturers must submit a Premarket Approval (PMA) application that contains results from clinical investigations.

FDA-cleared
Manufacturers can submit a Premarket Notification (also called a 510(k)) to the FDA.