Vivos Inc (RDGL)

[mc73]

Not surprised at this one bit. Looks like FDA will require only 1 additional test case and hopefully RDGL already has an example to submit. Most critical word in the Tweets: may. The FDA "may" request an (single, not multiple) additional animal test to prove once again (they have already proved it!!) the gel doesn't leak outside the tumor.

The FDA is ridiculous - there is plenty of test animal cases that prove this. This is extremely frustrating and not RDGL's fault in any way. Fingers crossed they don't require any further testing and tell us to submit the application for IDE. If things fail during human trials then the FDA can shut down human testing or demand changes to procedure or formulation...ugggghhhh!!! F the FDA!!!!