Replies to post #170520 on Vivos Inc (RDGL)

[kayak_wench]

The bullet in the Jan summary that got my attention was

"Akina successfully aseptically filtered so it can be sterilized. Root cause and the filtering effects on concentration are being analyzed."

One issue I have with this bullet is that this appears to be yet another hoop to jump through (I can just see the FDA at their last meeting saying "surprise, you now have to sterilize the hydrogel. We could have told you sooner but if we had you would be ready to submit."). Sterilization would be done to prevent contamination by bacteria, viruses, or other microorganisms. I don't see how this won't be a requirement for approval for use in humans.

What most worries me is the phrase "root cause and the filtering effects on concentration are being analyzed." Root cause of what? That is a phrase used most of the time (from my searching perhaps always used) to describe understanding how a failure occurred. I looked and couldn't find any definition that doesn't involve analysis of a failure of some sort. But they also say that the gel was "successfully aseptically filtered". Filtration is used before sterilization to remove most of the contaminants. Then additional sterilization steps can be applied to make something as close to completely sterile as possible. If they say that filtration was successful (in removing most of the contaminants) maybe the filtering had negative impacts on Yi-90 concentrations (and the root cause analysis is being done to figure that out). They could explain the conflicting statement if they criteria for successful was just whether most contaminants were removed and did not include the additional requirement of "contaminants removed without negatively impact the effectiveness of the gel".

Yes, I am feeding the negative folks fodder to toss around, but I think the purpose of the board is to share thoughts. I do expect to see people suggesting I sell though, not sure why they bother like I am going to listen to them or stop posting my thoughts.

I really would like more information on this item, but I am not sure how we will get it. The last 10Q had a comment about Akina

"During 2021, the Company engaged Akina, Inc. as an alternate supplier of its hydrogel polymer component. We have now expanded to include SciPoly as another alternate polymer supplier."

[SC8]

"enhances IP"

What IP? All the original patents have expired, Anybody can make a generic Radiogel should it ever get to market. RDGL's weak "improved" process patent can't stop that. The only way RDGL has to keep out generics is to price Radiogel close enough to cost that it's not worth anyone's time to bother competing. That limited pricing power in turn limits any potential buyout offer.