Vivos Inc (RDGL)

[SC8]

Nice straw man rebuttal. FDA doesn't need or want a statistically valid controlled and monitored human demonstration that Radiogel works and works safely. They need that valid demonstration with animals to consider human trials, and to date, in over two decades, no one has made anything close to such a demonstration. Without that, Radiogel ain't going anywhere anytime soon. MK's bogus safety conclusions based on sub-clinical doses in rabbits is junk science at it's finest. What was FDA supposed to do with such nonsense?

Time will tell if a valid human demonstration in India can make up for the lack of an animal demonstration, but that has to be with same formulation they intend to trial in USA for FDA to consider the data. That is impossible without operations in India manufacturing Radiogel to FDA standards, which seems at least two years away. Going this far more expensive and lengthy route in India makes no sense, unless that second set of never published rabbit results at JHU were a disaster, and RDGL is just a bogus stock selling scam for MK to live the high life in his remaining years.

Gotta feel bad for the bag holders