Replies to post #146892 on Vivos Inc (RDGL)

[SC8]

What process change? From Jan 2022 RDGL PR: "The Covid pandemic impacted our hydrogel production 2021. It removed our primary production technician and stopped the supply of one of our key production chemical components. I am pleased to report that through several months of effort involving IsoTherapeutics Group LLC, Akina Inc and Scientific Polymer Products Inc we have not only recovered from these setbacks, but have dramatically improved our polymer and hydrogel production process. We reduced the polymer production time and have increased the output by a factor of three. We have also further reduced the level of trace contaminants to be well below the FDA guidelines. The primary negative impact was to delay the initiation of the biocompatibility testing necessary for the IDE, which is now underway."

Can't make manufacturing changes like that with product component without starting over regarding finish product testing FDA will accept. Will add, once approved, it's very easy to lose FDA approval if manufacture makes such changes without FDA pre-approval.

[Malibew66]

it's proprietary trade secret, we do not know what the change was