Vivos Inc (RDGL)

[West Coast Snapper]

People want to opine but they have no facts and don't even know the proper terminology. It can be submitted as a Class 2 device because Y-90 is already approved And once injected into the tumor 99.9% of Radiogel stays in the tumor. The leakage is negligable and the surrounding healthy tissue isn't affected. The reason it was denied last time is because all the data that was submitted was generated at PNNL. That is where Dr Fisher did the work. Unfortunately the FDA didn't consider that independent 3rd party testing, hence the reason Isotherapeutics has been hired to redo all the animal testing. It is Fisher's opinion the data that was submitted was plenty for approval, so once that is completed again they'll meet with the FDA again and get their feedback on whether they are good to submit or if they want to see anything else. Pretty sure Fisher knows whether it should be class 2 vs class 3 considering he got Xofigo approved and sold to Bayer for $1B. I guess people know more than him, maybe fisher will decide to change it to a stage 3