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Data source: QIES database as of 04/13/2020
The database was last updated on 4/13. So there is hope that they have renewed it after the 13th..
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Laboratory_Demographic_Information
Yes. On this link click on the question "What serology tests are being offered...." It will have a list of all the labs, Arrayit included.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2
That's not the question I had for lucky.
But regarding your question, the form 15 they filed was for suspension of reporting only under rule 240.12h-3, not to de-register.
240.12h-3 - Suspension of duty to file reports under section 15(d)
They need new and better management for sure.
Find examples.
Only if they had over $10M in assets on 12/31/19.That has been the caveat all along.
Mark did not promise fins "DUE END OF APRIL"
If they didn't have over $10M in assets on 12/31/19, under rule 240.12h-3 they wouldn't have to report this year.
Question is whether the SEC is OK with them choosing that rule only on the form 15 they filed in August 2019.
Time will tell when the SEC investigation completes.
I don't think the FDA cares about the fins. Thy only care about the validity and accuracy of the test. The SEC is the one that cares about fins.
OK, I see the disconnect.
The filed the form 15 in August 2019 so they qualified because the prior 3
years at that time were 2016, 2017 and 2018. So each of those years they were under 10M.
Come 2019, we don't know what their assets were on 12/31/19.
But if they were over $10M, then 2017, 2018, and 2019 are not all under 10M
What omission?
TO BE ELIGIBLE for the suspension in the first place, all 3 prior fiscal years needed to be under $10M
What kind of fraud?
You well know that the suspension is just the beginning, and the investigation is still in progress until the SEC completes its administrative proceeding. The company will also have its say in the proceedings. The SEC could take, or not, take further action.
They qualify for the rule if the assets were less than $10M in each of the most recent 3 fiscal years.
They will not qualify any longer when one of the years is more than 10M
The SEC is aware of the form 15 that Arrayit filed. We have to wait and see if they take that into account when they decide what administration action, if any, they will take against the company
Fewer than 500 holders of record. As of August 2019 Arrayit had 374 per the form 15
Arrayit filed a form 15 in August 2019 and checked only the box for Rule 240.12h-3 - "Suspension of duty to file reports under section 15(d)."
Read the details about that rule here:
https://www.law.cornell.edu/cfr/text/17/240.12h-3
If I read that rule correctly, if Arrayit had more than $10 million in assets as of 12/31/19 they are supposed to file a 10K for 2019 not later than 120 days after the end of 2019.
If they did not have $10M in assets, they would not have to file.
But the SEC is now involved, so we'll see.
Only if thay had over $10M in assets as of 12/31/19 does that deadline apply.
You meant 2M?
The grey and expert markets are tiers of the OTC market.
Some people were predicting (hoping?) for trips prices. So 0.01 is not so bad.
• Applied Biosciences Corp. (SYMBOL: APPB; CUSIP: 03815L102)
• Arrayit Corporation (SYMBOL: ARYC; CUSIP: 04269N107)
https://www.dtcc.com/legal/important-notices?subsidiary=DTC&q=aryc&pgs=1
Resumption of DTC Services – 4/29/20
• Applied Biosciences Corp. (SYMBOL: APPB; CUSIP: 03815L102)
• Arrayit Corporation (SYMBOL: ARYC; CUSIP: 04269N107)
https://www.dtcc.com/legal/important-notices?subsidiary=DTC&q=aryc&pgs=1
I think expert market is a lower OTC tier than the grey market.
Arrayit test:
People still have to go to a Quest office to give them a vial of blood.
Rene is the CEO. Her husband Mark is the president.
a pulse now at 0.015
What has ARYC said about "the accuracy and breath of the test"?
jhols1, thanks for sharing.
Did they mean "95 % Sensitivity and specificity" for each.
95% specificity is not too good. It means 5% false positives.
95% sensitivity is good. 5% false negatives.
"The false-positive metric is particularly important. The result may lead people to believe themselves immune to the virus when they are not, and to put themselves in danger by abandoning social distancing and other protective measures"
"But false positives become dangerous when making policy and personal decisions about who can go back to work. “You don’t want anybody back to work who has a false positive — that’s the last thing you want to do,” Dr. Krammer said."
https://www.nytimes.com/2020/04/24/health/coronavirus-antibody-tests.html?action=click&module=Top%20Stories&pgtype=Homepage
are you buying the dip?
twisted words matter.
The SEC suspension order did not say:
"Arrayit Corporation (ARYC) on April 13, 2020 for claiming that it had developed an approved COVID-19 blood test."
It said:
The tipping point was the covid-19 test, The SEC and DOJ are cracking down on people and companies trying to take advantage of the crisis to sell dubious products.
IMO Arrayit was caught in this net, not by any false statements the company itself put out, but by other people making false claims about the test being "approved". We had good news about having a test submitted to the FDA for emergency authorization, but it wasn't enough for the pumpers so they twisted the message on social media. The SEC was alerted by people at war with the pumpers. And here we are.
Arrayit can distribute their covid test while it's being reviewed for emergency authorization. The FDA does not object to the distribution of the test.
that "if any" is a boiler plate phrase used by the SEC and appears in most suspension letters for companies that have not filed in a long while.
Well, let's see what the SEC report about ARYC says.
This report about NBDR was filed on 4/20 the say that their suspension ended.
ARYC suspension ends on 4/27. Will we see the SEC report then?
So the FDA website that includes the Arrayit test is lying?