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We get the Mayo Clinic's IRB thumbs-up and we are good to go for human clinical trials.
OVERVIEW
The Mayo Clinic Institutional Review Board (IRB) ensures that the rights and well-being of potential research subjects are adequately protected.
The Institutional Review Board is charged with reviewing all studies involving human subjects for compliance with both Mayo Clinic institutional policies and with state, local and federal laws. The IRB also ensures that all studies comply with the ethical principles contained in the Belmont Report, such as respect for people, beneficence and justice.
The Mayo Clinic IRB is made up of four committees comprising at least five members, including Mayo Clinic scientists and nonscientists, and at least one member who is not affiliated with the institution.
In general, an institutional review board is a committee charged by the U.S. government with protecting the rights and welfare of human subjects involved in research. The use of IRBs began in the National Institutes of Health (NIH) when a memorandum issued in 1966 required that investigators receiving funding from public health grants obtain a review of research by a committee of institutional associates.
Your parents didnt get the "more rabbit testing" message doc pinned to back of your shirt before leaving school the other day? Sorry about that.
Radiogel.com
The Mayo Clinic Institutional Review Board (IRB) has Dr. Korenko back. Pay close attention here, very important.
https://www.mayo.edu/research/institutional-review-board/overview
Why in the hell would Doc say rabbit testing is all done and then keep testing? That makes no sense.
FDA is requesting it. That makes more sense.
Radiogel.com
Sorry to tell you this, but Doc isn't going nowhere. So get it out of your head.
Radiogel.com
April FDA meeting, reviewers weren't satisfied and wanted more data. Hence more rabbits. Doc thought they were done testing rabbits too. But as you can see, FDA wanted more and more and more testing. So Doc is giving it to them. You call it lying, I call it blindsided.
Radiogel.com
Key takeaways from update are, reduced costs to pet owners by reduced costs of shipping and handling of Isopet. And another first, moving away from cancer and trying its first ever in treating caudal heel pain syndrome in horses. If successful, big market there. And last, the best part (copied and pasted) After receiving FDA approval to conduct clinical trials we need formal approval from the Mayo Clinic IRB. In anticipation of this step and to help expedite the proccess we have submitted the Clinical Trial Protocol to their “gatekeeper” for comments. We have also been conducting certification training for Dr. Paz Fumagalli. Next quarter we are planning to complete the final training certification step using high activity RadioGel™ in a full-dress rehearsal operating theater.
Radiogel.com
Thanks for posting. Looks like great progress being made. IDE is a few months away.
Radiogel.com
See, not a bad report at all. Not sure why they held off not reporting first business day of this quarter, but still tons of stuff still going on behind the scenes. More rabbit testing only solidifies the data needed for IDE, and the Genotoxicity testing is now a go.
Hell, they even started testing on mice for future indications. Another plus
Radiogel.com
FDA Keeps moving the goal post. They do that to small Pharma's. Can you imagine a penny stock cancer treatment that works getting approved? Either could I until FDA lets it happen.
Radiogel.com
And right in his ear too. Good for Korenko to clean house so he can concentrate on better things.
Radiogel.com
Thank you! Im running out of posts.
Radiogel.com
This offer was amended, and this statement is over a year old. They are very much farther ahead then what you think.
Radiogel.com
Exactly, you don't know Korenko.
Mods.....sticky his post. He finally admitted the truth for once. CONGRATULATIONS!!
Radiogel.com
Will.........
Radiogel.com
pps about to go up, why in the hell would I sell? Very strange request. Wow just wow.
Radiogel.com
Glad to hear you're counting after Korenko 7 years. He'll be The Great CEO for many more years to come, and very soon saving human lives.
Oh, and tell your wife im sorry for treating her like a grain of sand. Kinda like what you do with your ex boss.
Radiogel.com
All your option and it dont mean squat.
Tic Tic Tic...
Radiogel.com
Nope, but I did piss his wife off. She's goin to throw me in Ihub prison. Yikes!
Radiogel.com
Glad to see you admit they'll get human trials.
Radiogel.com
Green is when you make money, red you lose. Thats how it works. Seriously?
Radiogel.com
Dont hold back reporting me, I'd rather get the jail time then bow to your forgiveness post. Better yet, ill just block ya.
One more thing, i can't find one of your post that benefit Radiogel in a positive way. No news, no reports, no tweets, just "I hope".
Radiogel.com
Ha!
Radiogel.com
Some peoples kid's.
Radiogel.com
Oh, and another thing. I didn't hear you complain once about a particular poster here kicking a "Great" CEO to the ground 3500 times. Wow just wow
Radiogel.com
You sound like another Debbie Downer on this board.
If you haven't been paying attention, we are extremely close to news. And it's not bad.
Radiogel.com
If it's so irritating with 5 same-O same-O posts, just block them. Or take that long awaited vacation you was talking about.
And since your fingers massage the crystal ball of how IDE will pan out.....why did you buy in so early? Or wait...your free shares?
Radiogel.com
Great questions, send it in.
Radiogel.com
Why give him flak? We are green today, and it's pretty much what he stated yesterday.
So....what does Crow taste like?
Radiogel.com
Let the human trials begin.
Radiogel.com
I remember Sirtex going private with shareholders but didn't realize who had bought them out. My bad!
I keep seening Sirtex links popping up here on this board, and on Vivos Twitter feeds. Just wondering if there something in the works.
Sirtex is a very large user of Yttrium-90, maybe thier looking for a hydrogel to add?
With 18 cancer indications, valuations should be in the billion$ I would think.
Radiogel.com
When was Vivos worth 1.4 Billion? And what does Sirtex have to do with it?
Radiogel.com
I see you disappearing in a couple weeks. Thats all I see.
Radiogel.com
You poor deprived investor you.
Your 3000 plus post tells me you get paid. Objectively well.
Radiogel.com
If one has their head tucked in a dark location, they wouldn't know this information. Pull head out and you'll see.
Radiogel.com
All this will change soon and your job here will be over. Tic Toc.....
Radiogel.com
BIGGEST update in Vivos inc company history. Bet on it.
Radiogel.com
IDE approval.
Radiogel.com
Remember how many time it took you to ride a bike......with training wheels? I do, and you still fk-ed that up cuz you kept looking "downward" and you kept getting your foot stuck in spokewheels? Good times!!
But here we are calling kettle black.
Radiogel.com
I'll go with glass half full its possitve news. Which you failed to offer over 3000 times. Wow!
Radiogel.com