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Re: myjog post# 15246

Monday, 11/14/2022 7:16:42 PM

Monday, November 14, 2022 7:16:42 PM

Post# of 15258
10-Q out. it contains proof that the CEO didn't steal $3.3 million.


There's also an update on the US clinical trials:

In the United States, the Company is actively pursuing FDA approval by initiating a clinical trial protocol involving approximately 400 study participants. The protocol was drafted with input from FDA and at least two prestigious clinical centers that will participate in the study. Additional clinical centers may be added if needed to meet the study’s enrollment criteria. Budgets have been agreed to with both institutions. The LuViva devices have been prepared and have passed bench testing to begin the study. On July 20, 2022 we announced that the study had been approved by the designated central Institutional Review Board (“IRB”) and because of that, we initially expected to begin in September or October of 2022. On November 9, 2022, we received a letter from one hospital’s IRB that we were conditionally approved to start the study, pending responses to three questions, which were provided to that IRB on November 10, 2022. Currently, both clinical sites are finalizing correspondence with the designated central IRB and getting final signatures on contracts so that we can start the study before the end of 2022, which would allow the study to be completed in the third quarter of 2023, however, there can be no assurance that the study will be completed within this timeframe.

Of course, that won't please everyone (as if anything could), but I'm fine with it. They are taking extra care with FDA attempt #4, avoiding the mistakes of previous management that led to three FDA rejections.

There's an update on SMI too, but I'm not a fan of SMI.

As for evidence that the Directors are "real people...." Can you give me the name of an Officer or Director you think is fictitious? Certainly not Cartwright, since you libelously accuse him of multiple felonies..... and certainly not Lou Posner at Auctus, who signed the 10-Q as Managing Director....

I think it's important to do some DD on this company's FDA and financing history. In a nutshell, they were overconfident about FDA clearance on their 3rd attempt, so they had no backup contingency plan for rejection... but pre-Cartwright management was incompetent. When the FDA rejected the 3rd attempt, Cartwright was the new CEO and caught in a trap. They did a couple of R/S that sent the PPS into a freefall because the company was mired in death spiral financing, but somehow Cartwright pulled them out of the death spiral so when they did the last R/S the resulting PPS of 15 cents held. And it went up. And it's still up.

And somehow Cartwright avoided the R/S they were planning to do in 2022.

And not only don't they file NT 10-Q's anymore... they're a day early with this one!

Cripes. What's not to like here? Look at that float. They're going to get FDA clearance on the 4th attempt because they're sucking up to the FDA this time. It's not going to happen next month or next quarter but it's going to happen.

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