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It was an Apple Enterprise Healthcare partner, and you’re right, nothing about that was mentioned in the affidavit or indictment.
Hi SK510. Well, I will try. Post #198204 explains in very simplified terms what I think could have happened, which would not be unusual at all! ARYC was new at all this Medicare billing stuff, so those allegations could have been due to mistakes or misunderstandings. Let’s face it, our health care system and specifically Medicare is convoluted, there’s plenty of room for error on both sides. Plus I am not even sure Arrayit does its own billing. “Kickbacks” and “bribes” could be prosecutor-speak for commissions and bonuses, and could have been offered to anyone who brought in new doctors and clinics. The tech is cutting edge and still fairly unknown and/or accepted in the world, but for crying out loud, it was Mark who invented and patented the tech and equipment used in the whole science of microarrays. Is it a crime to get the word out to professionals by promising bonuses and commissions to distributors and/or professionals?
For me, the bottom line is that Mark would not want to sacrifice his entire life’s work, and Rene’s, by deliberately defrauding Medicare. I mean I am sure he knew what would happen if he dared to suddenly turn into a psycho criminal, and being a fairly new Medicare provider, those types of crimes would still be fresh in his mind, you would think, and he would not want to jeopardize ARYC’s “deemed” and new provider status that they worked so hard to attain.
There are so many erroneous statements in the affidavit and charges that sounds like their “investigation” was lacking, and as I have said before, much of it sounded like the “hearsay” fed to the SEC.
Hoping for the best as always! According to the FDA, Arrayit is STILL allowed to offer their Covid-19 test as of today, while awaiting EUA status. And what’s up with the volume and share price over the last few days? Makes ya wonder.
Crazy stuff. But you asked! :))
It is dumb to compare Arrayit to Theranos. Do you SEE THERANOS' TEST on the FDA WEBSITE allowing them to offer their tests to professionals while they wait for Emergency Use Authorization? Nope, not there.
But who is there still, even after all this insanity? Why it's ARRAYIT CORPORATION, updated as of 6/18/20. Check it out!
You know, the ones that led up to doomsday last April..."confirming" this and that, "we're working over the weekend to get it done.." Apparently there were 38 such emails, but I don't remember there being that many, but it sure sounded like they would file by 3/31/19 or 4/1/19 at the very latest. That was a huge disappointment to everyone. But was it really Mark sending them out?
Just saying it is a possibility. Prosecutors like to make things sound worse than they really are, i.e., "fraud" could be a mistake or misunderstanding; "kickbacks" and/or "bribes" could actually be bonuses or commissions, and so on.
It happens all the time!
That remains a mystery. I remember he said they were awaiting "further documentation," and I was never sure it was Mark who was sending out all those reassuring emails either. Maybe that will all come out...
Accusations are not proof. Who knows what sort of tactics were used to try to intimidate her and throw Mark under the bus. That could be just another hole in their case.
DOJ: Did you ever conduct a panel of tests for allergies that were not specifically ordered and bill Medicare?
Dr. T: Well, yes. The panel can discover all sorts of ailments, including Covid-19.
DOJ: Well that is FRAUD. Did Dr. Schena know about this?
Dr. T: Well, yes. He felt it was important to distinguish COVID-19 from allergy problems, as Dr. Fauci pointed out in a press conference.
DOJ: Would you be willing to testify to that in a court of law if we give you certain concessions? It might save your reputation and practice if you admit that Mark Schena participated in this fraud.
Dr. T: Ummmmmmm. OK.
WRONG. That is JUST one of many errors in the esteemed Postal Service Inspector's affidavit. I showed you who proclaimed him the "father of microarrays." It was NOT MARK. It was based on his research on microarrays and Parkinson's Disease. Don't believe everything you read. Stick to the FACTS and the TRUTH.
Wrong. Show us where that was self-proclaimed. You can't because it is NOT TRUE. My post was TRUE.
That would be dumb and premature. Until found guilty, he is presumed innocent.
Maybe to those who can't see the forest for the trees.
“Schena was proclaimed the "Father of Microarrays" in an article written by Lloyd Dunlap, contributing editor of Drug Discovery News, in an account of Schena's pioneering work to decipher Parkinson's disease.”
Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 6/18)
A: Arrayit Corporation. (1 of 27)
Updated yesterday.
The article has just as many holes in it as all the others. I love the way they always put “microarrays” in parenthesis as if it’s not a viable science. Mark “capitalized on a national emergency for his own financial gain”? Where is the evidence on that one? Are they trying to say Nielsen split his whopping $137K profit with Mark? Are they saying Mark was doing his own insider trading? They never mention the stock doubled from about .01 to .02 or .02 to .04. The way it is worded, “doubled” could mean from $10 to $20.
As to Jason Nielsen’s “false and misleading statements,” which IMO were not even that, what about the false and misleading statements that were fed to the SEC?
You are wrong. The Form 15 was In PLACE at the time of the suspension. The SEC freaked out over hearsay fed to them about ARYC’s COVID-19 test, unless the wording and timing were simply coincidental, which would be very odd.
Hi ScorpGirl. Yes, I agree about Mark.
How much fun would it be if the whole dang thing was dismissed?
:))
The SEC accepted ARYC's Form 15 filed last August, so ARYC was LEGAL with the Form 15 IN PLACE at the time that same agency suspended ARYC. I mean, who's on first? lol.
Your beloved SEC makes mistakes, REALLY BIG ones, not to mention being involved in conflicts-of-interest, ignoring shenanigans of Bernie and similar crooks, giving big breaks to the BIG BOYS for causing a financial crisis of the worst kind, destroying evidence, etc. and so on.
And here they are complaining about $137,000 made by a shareholder in this ENORMOUS PUMP AND DUMP scam, which doesn't even exist, spanning over a 90-day period! How DARE he get away with that? How DARE he make money in the stock market?? How DARE he post positive comments about a company he holds millions of shares in and believes in?
I mean, give me a flipping break.
Wrong. Each of those corporations were formed for specific purposes, one being formed specifically for OvaDx, which eventually morphed into Avant Diagnostics. Two of those corporations have been inactive since 2012. No annual reports were filed. Arrayit Corporation is the only one now active, with another “marketing” corporation that doesn’t have anything going on. All corporations were subsidiaries of Arrayit Corporation all along anyway.
I know it is not looking all peachy, but the points I have made are at least true and valid and not based on one-sided speculation or any assumptions. Maybe it’s all true and maybe it’s not. I still have a hard time believing Mark would jeopardize everything he has worked for his entire life by suddenly becoming a criminal, and let’s face it, some of the allegations and statements are simply not factual and show a lack of understanding of the science of microarrays.
And as of this morning ARYC is STILL on the FDA’s list! How can that be? Why haven’t they taken them off the list and / or told them to stop making their Covid 19 test available???
There was no pump and dump! Look at the numbers. Much to shareholders’ dismay, Arrayit has been extremely quiet since last August when they filed the Form 15. It was like pulling teeth to get them to say anything at all. Visiting the website was what gave us the first clues that Arrayit had a Covid test. It’s not like they issued a PR or 8K or hired a stock promotion company claiming something that wasn’t true. So where was the pump? Nielsen may have misunderstood since the FDA allowed ARYC to offer their Covid test while awaiting EUA status, so in a sense the FDA did “authorize” ARYC’s test. Neither the company nor Nielsen ever claimed Arrayit’s test had received EUA status.
If you look at the volume and share prices, you won’t see any P&D either. There were some huge volume days all right, but they were mostly due to shareholders selling their positions on bad news, i.e., the expected filing of financials that didn’t happen and the suspension by the SEC. ARYC didn’t dump shares into the market and mess with the share structure by diluting either, which was insinuated by the U.S. Postal Inspector.
Like.
You are making assumptions and speculating when you should just wait it out to see what they can PROVE. Nielsen sold 40 plus million shares for low prices like .03 and .04 (can’t remember exactly) when he could have sold at .19 or .20 a few weeks prior to the non-filing of financials last April. He could have made many more millions if he had any inside information that financials were not to come by selling at those much higher prices. Does that sound like he was in cahoots with Mark and Rene?
Your story makes no sense at all. Let’s see what the judge or jury decides after listening to both sides.
Really? Show us.
I am not a liar.
Me too, MM. What a pleasant day for VYST in both volume and price! Wonder if something REALLY BIG is on the horizon!
No, NONE of that is "safe to say." Let them prove their case and present their proof to an impartial judge or jury when BOTH sides will have a chance to be heard.
Innocent until proven guilty. The DOJ's case has many problems. Some of the allegations can already be proven to be wrong, and some of the statements made demonstrates how little any of them know about the science.
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test
For Immediate Release:
June 16, 2020
Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test. Antibody tests, a type of serological test, can help provide information on a person’s and population’s exposure to COVID-19.
“Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.”
The Chembio antibody test was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency. At the time of authorization, based on the information that Chembio submitted to the FDA at that time, the agency concluded that the test met the statute’s “may be effective” standard for emergency use authorization, and that the test’s known and potential benefits outweighed its known and potential risks.
As the FDA has learned more regarding the capability for performance of SARS-CoV-2 serology tests during the pandemic, and what performance is necessary for users to make well-informed decisions—through both the continued review and authorization of serology tests as well as through a research partnership with the National Institutes of Health’s National Cancer Institute (NCI)— the FDA was able to develop general performance expectations for these tests, which are listed in our serology templates.
Data submitted by Chembio as well as an independent evaluation of the Chembio test at NCI showed that this test generates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device. Under the current circumstances of the public health emergency, it is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test, including the high rate of false results. Moreover, the risk to public health from the false test results makes EUA revocation appropriate to protect the public health or safety. As such, the FDA decided to revoke the emergency use authorization of the Chembio test, and this test may not be distributed.
The FDA will continue to monitor the performance of tests marketed in the U.S. and take actions, as appropriate, including modifying its policies.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chembio-antibody-test?utm_campaign=2020-06-16%20FDA%20Revokes%20Emergency%20Use%20Authorization%20%28EUA%29%20for%20Chembio%20Antibody%20Test&utm_medium=email&utm_source=Eloqua
That's not true. If you had inquired, you would have received the same email. There was no exclusive club. Nielsen was one of many who received the same email, which did NOT CLAIM THEIR TEST WAS APPROVED BY THE FDA. It's absurd to think Mark and Rene are posting on this board, or ever did. They have better things to do, like running the lab and working on their Covid-19 test.
That is not a crime, especially since they were continuing to work on it. The FDA gave them "Pre-Emergency Use Authorization" status. The FDA did not tell Arrayit to cease offering their COVID-19 test either, and as far as we know, still hasn't.
Still on the FDA list - Covid19
Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 6/15)
A: Arrayit Corporation
Must still be in "Pre-Emergency Use Authorization" status.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
Nothing is "safe to say" at this point. Nothing has been proven and the case against Schena is flawed in many ways. We will just have to wait it out and hope for the BEST.
Or, many will hope for the WORST.
Maybe the DOJ figured out their case is full of holes and doesn’t want to risk a trial. Better to settle than have the whole thing darn thing dismissed and look goofy.
5.96 million in volume, up 12.5% as of 1:37 p.m. Very interesting.
You can't know that - ARYC is trading in the Expert Market - non-pubic information. No little people allowed!
You are wrong! The FDA did NOT reject the test. The 85.7% sensitivity and 88.1% specificity did not at the time qualify for a EUA, so the FDA converted it to a “Pre--Emergency Use Authorization.” Arrayit and its Covid 19 test is STILL on the FDA’s list as of 6/15/20...yesterday. The FDA did not tell Arrayit to stop offering their test. According to Mark last week, they are continuing to work with the FDA.
If these aren’t signs that ARYC’s test is still in the running, then I don’t know what is.
Yes of course there are red flags all over the place. On the other hand, the SEC did nothing about the late filings and Arrayit was operating under a Form 15, which was perfectly legal and acceptable to the SEC right up until the Covid-19 lies were fed to them. They were seeking out “fraud” relating to Covid 19, and in their twitchiness to find a bad guy, they went after Arrayit based on that hearsay. If they had done a proper investigation, Arrayit would not have been suspended. I always thought the company would file 2 years of audited financials under the delinquent filers program, which was created for small companies like ARYC. Would love to see that happen.
The language in the suspension included words and phrases that sounded almost verbatim to what disinformation the SEC was gobbling up.
Innocent until proven guilty. That’s all I’m saying.
Before anyone calls Arrayit a "scam," they should do some DD on the company. I don't like what is going on anymore than the next person, but the suspension for COVID-19 fraud was initiated because of lies and distortions fed to the SEC. Let's see what kind of PROOF they have.
You can't believe everything you read. Innocent until proven guilty.
Yeah, maybe they should be INDICTED for trying and failing to please the FDA the first time around. How DARE they! Lock 'em up! Destroy them!
There is a real possibility that the matter could be dismissed against Mark. There are so may untruths that stand out already in the indictment. Who knows what else is false?
Could it be that Arrayit Corporation was not named because their Covid-19 test has promise??
If Abbott's test was SO bad, then why not? This is life and death stuff.