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The list is available for all to see
I haven't gone into too much depth with the others
Is there a particular question you have ?
Wow I couldn't agree more
"It's in their Press Release."
What is in their press release ? They never mention Daan in there
" With a contract of this size, they would be working directly with the parent company."
Does this mean there is no hard evidence ? The word "would" makes me think you are just making a guess or deduction.
"would" is different from "they ARE working directly"
I can't find anything to suggest PRED has any relationship with Daan Gene
Why do you think so ? What is that based on ?
I found info on the internet that said Daan can make up to 500,000 per day max. Far cry from 1.5 million
The Press release you are looking for is here :
https://predtechgroup.com/news/predictive-technology-group-announces-launch-of-assurance-ab-covid-19-igm-igg-rapid-antibody-test-for-use-by-laboratories-and-healthcare-workers-at-the-point-of-care/
"Assurance AB COVID-19 IgM/IgG Rapid Antibody Test is being manufactured in cooperation with Jiangsu Dablood Pharmaceutical CO, Ltd. Dablood Pharmaceutical has successfully distributed 38 million tests to date throughout Asia and Europe. To the best of Predictive’s knowledge, Dablood Pharmaceutical is one of very few companies approved by the Chinese government to co-develop and manufacture rapid antibody tests. Dablood Pharmaceutical is one of the largest diagnostic kit manufacturers in China and is currently producing up to 1.5 million units of the rapid antibody test per day in China. Predictive evaluated other potential developers and suppliers and believes Dablood Pharmaceutical provides not only existing inventory, its high-volume production capacity enables them to rapidly increase production to provide high-quality tests to meet rapidly expanding global demand. Dablood Pharmaceutical has been recognized by the Chinese government for its effort of developing and producing testing products to help the detect the COVID-19 and has received approval for distribution of its test across the domestic Chinese market and the European Union with a CE mark."
The CE mark is true.
"has received approval for distribution of its test across the domestic Chinese market" - this is ABSOLUTELY FALSE. Dablood is NOT on the list (yet). The "grandfather" company Daan is on the list for their PCR test NOT igg/igm.
https://www.360dx.com/immunoassays/faced-confusion-questionable-claims-fda-addresses-coronavirus-serology-testing#.Xo9keWNKiM8
This should help clear the air on the usage of the words "approved" and "authorized"
"Since the FDA began allowing serology-based SARS-CoV-2 tests to be marketed under policies C and D, some firms have launched their products with dubious claims about their regulatory status, which has caught the FDA's attention. The agency is trying to make it clear that firms that have gone through Policy D are not EUA authorized, and on Tuesday FDA Commissioner Steven Hahn issued a statement stating, "Some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. The FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.""
So we can clearly see that PRED is NOT FDA "approved" further it is NOT FDA "authorized". Any such claims are false and the FDA will take action
We can all agree that PRED and many others are "POLICY D", and only CELLEX (at this point) is "EUA" aka "POLICY C"
Also interesting :
""It was not our intention to limit the use of rapid serology tests that are otherwise designed to be used in a point-of-care setting. However because of the limits that we have in law, it is the opinion of [the Centers for Medicare and Medicaid Services] that these can be performed in high-complexity labs," Stenzel said. He added that developers can choose to come through a full EUA authorization process so that a test can be deemed point-of-care and be allowed to be used in waived settings."
Was PRED planning on selling to point of care ? Because according to that paragraph they can only sell to labs unless they get the EUA.
"Stenzel followed up to say that the agency may not yet have made clear that point-of-care tests marketed under Policy D are considered high-complexity tests, as there are two related posts on the FAQ page. "We'll try to resolve the confusion on the website," he said."
According to that they admit it was an easy mistake to make. Maybe PRED thought they could sell to point of care as well. No harm no foul.
Also you said AYTU manufacturer was HK based
According to this link :
https://www.benzinga.com/general/biotech/20/03/15517719/penny-stock-aytu-bioscience-skyrockets-on-covid-19-rapid-test-distribution-deal
The Hong Kong company isn't actually the manufacturer. They seem to be a middle man. Zhejiang Orient GENE is the manufacturer.
Does your research agree?
https://www.google.com/search?sxsrf=ALeKk03tO0NGUp_GO3FBiNFK0dy14P4uwA%3A1586125215195&source=hp&ei=n1mKXtnnCM7usQWQo4aYDA&q=120%E4%B8%87%E4%BA%BA%E4%BB%BD%2F%E5%A4%A9&oq=120%E4%B8%87%E4%BA%BA%E4%BB%BD%2F%E5%A4%A9&gs_lcp=ChFtb2JpbGUtZ3dzLXdpei1ocBADOgcIIxDqAhAnOgUIABCRAjoFCC4QkQI6AggAOgIILjoECAAQCjoECAAQDDoECB4QCjoFCCEQoAFQnDJY64QBYPqJAWgEcAB4BIABjweIAcM1kgEOMS4xMS4zLjMuMS4yLjKYAQCgAQGwAQg&sclient=mobile-gws-wiz-hp
that google search shows a bunch of articles talking about the 1.2 million per day number. It will show as "120" because chinese uses multiples of ten thousands (they don't have a word for million) so its 120x10k per day
The same report says they have sold a TOTAL of 10 million kits for ALL companies (for Guangdong Province where Daan and Darui are located - the companies who are given credit for the Dablood kits) which is way below the 38 million PRED said.
Just to be clear Dablood never claimed to be able to produce 1.5 million per day or have sold 38 million kits. That info can ONLY be found in the PRED press release. I can't find it anywhere else.
"authorized" ?
I think there was an earlier debate about using the terms "authorized" and "approved"
Because we already know that only CELLEX has an EUA and the "A" in "EUA" stands for "authorized"
So then we have 2 versions of authorized ?
That list is of companies is :
"A: As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:"
Maybe it's safer that we say they are "not objected to" - or "permitted" or "notified the FDA they exist" but the use of the word "authorized" I think some, and maybe even the FDA would obeject to IMHO
Really, just call please
I think you can guess what I found but no one will believe it. And I never saw PRED claim anywhere they had exclusivity anyway so no matter what happens PRED isn't lying here so why does anyone care anyway? So what someone else in America can sell kits. Not sure why you would care. I was just answering nicksb24 question (or at least trying to. My information could be wrong of course)
So try yourself
"Hi, I heard you guys have great kits. Can I buy some ? MY address is xxxx USA"
I know "no one" (I'm not sure if "no one" maybe "someone" is quietly reading, doing their own checks etc) will believe me.
That's why I encouraged you to call yourself.
Then you won't need to believe me it will come straight from the Dablood's / Horse's mouth
I'm still doing more checks (not easy)
But no one will believe me anyway so if anyone think's it's important then I encourage you to call Dablood and try to order some Dablood kits and tell them they are for the USA
Watch what happens ...
If you are a physician I would be very interested to know what you think of the data PRED provided about their clinical trial.
Also, is there some 3rd party website that posts the data of all these trials that we can check ?
I have found evidence of Dablood's sales to other people and channels.
Also you will notice the name in the FDA list is Dablood's name NOT PREDs
Smart move on Dablood's part to apply themselves with their own name.
We haven't seen any evidence of an exclusive sales deal and I have in turn found evidence that there is no exclusive deal in place.
I just stumbled upon this. Reminds me a little of a stock I know named PRED lol !
"Rapid COVID-19 Tests Rolling Out Across the Bay Area"
"“We do a finger stick and it takes no more than 10 minutes,” Washington said."
“Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests,” said FDA Commissioner Dr. Stephen Hahn."
https://www.baynews9.com/fl/tampa/news/2020/04/09/rapid-covid-19-tests-rolling-out-across-the-bay-area
This is very interesting.
But surely as the stock goes up the short is losing more and More money. Surely he has to show he is good for the money in case the stock keeps going up right ?
Say he shorts 100k worth of stock. In order to short 100k he would have to give some sort of deposit for that no ? Would he have to give 100k deposit to short 100k of stock or could he get away with less ?
And then eventually if the stock keeps going up he would either have to get out and lose X or keep giving more and more deposits in hopes the stock will tank?
Is my guess correct ?
I’m interested in the clinical study Pred is referring to. You know the one with all the % numbers
The clinical study I got from Darui/Dablood about their tests have all different numbers.
Can anyone help find more info about the clinical study Pred referred to ?
Well as you can imagine I’ve got some more research to do so gotta take a break from the board
Thanks for the new work guys
See ya
Ps i predict $2 tomorrow also, just for the fun of it :) this has gotta be worth at least $2!
Ok hold on !
Is my new best friend Ferguson this guy ?
https://www.sec.gov/litigation/litreleases/lr17328.htm
Charged with false press releases ?
OMG you just made my day !!!!!
Please tell Ferguson thanks a lot.
The product is already in the USA?
Thanks that was helpful
Yes I don't know.
That's why I asked.
What’s all that talk in there about $0.86 a share ?
It’s trading over a $1
Wow this is great stuff
I love me some official links and lists
Thanks guys
Glad you asked
You thought I did research for free ?
Anyone else that stupid ? Lol
Am I supposed to care what Ferguson thinks ?
In case you were unsure I dontt
Again. Thanks
Really helpful !
I’m just a researcher
Neither long nor short
Another helpful link
Is that listing related to their covid kit ? Is it is just a general listing for anyone in this business?
I’m not sure about that.
I’ve seen news articles about fda clamping down on people/labs doing tests as well as sales direct
We all know sales direct is a big no no but even labs doing tests are getting cease and desist from fda
Always appreciate your informative replies
I’ve seen a lot of claims about preds “fda status” but can’t verify anything yet
Even the companies who aren’t authorized are on that list as pending or submitted or whatever. I would have thought pred would be on that list as “applied “ or something
So are you saying they don’t have an EUA ?
This should be easily verifiable
What is PREDS actual FDA status ?
So your answer is “it’s there you just have to find it and I’m not telling you where it is” ?
Lol
Still no info as to why pred isn’t on the fda list when other companies with EUA are .....
How would I know ? I just do research
Here is the FDA list from the FDA website
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Why isn't PRED there if they have an EUA ?
Does anyone have a link to PREDs EUA ?
Copy paste the list below
04/06/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit Healthcare Providers Patients IFU None
04/03/2020 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit Healthcare Providers Patients IFU None
04/03/2020 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit Healthcare Providers Patients IFU None
04/03/2020 Luminex Corporation ARIES SARS-CoV-2 Assay Healthcare Providers Patients IFU None
04/02/2020 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System Healthcare Providers Patients IFU None
04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx assay Healthcare Providers Patients EUA Summary None
04/01/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test Healthcare Providers Patients IFU None
03/30/2020 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel Healthcare Providers Patients IFU None
03/30/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay Healthcare Providers Patients IFU None
03/27/2020 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay Healthcare Providers Patients IFU None
03/27/2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 Healthcare Providers Patients IFU None
03/26/2020 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV Healthcare Providers Patients IFU None
03/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 test Healthcare Providers Patients EUA Summary None
03/24/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (April 1, 2020)
03/23/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test Healthcare Providers Patients IFU None
03/23/2020 BioFire Defense, LLC BioFire COVID-19 Test Healthcare Providers Patients IFU None
03/20/2020 Cepheid Xpert Xpress SARS-CoV-2 test Healthcare Providers Patients IFU for Labs
IFU for Point-of-Care None
03/20/2020 Primerdesign Ltd. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay Healthcare Providers Patients IFU None
03/19/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test Healthcare Providers Patients IFU None
03/19/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct assay Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020)
03/18/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 assay Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (April 1, 2020)
03/17/2020 Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 26, 2020)
03/17/2020 Quidel Corporation Lyra SARS-CoV-2 Assay Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 23, 2020)
03/16/2020 Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test Healthcare Providers Patients EUA
Summary None
03/16/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 Healthcare Providers Patients IFU None
03/13/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 24, 2020)
03/12/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 31, 2020)
02/29/2020 Wadsworth Center, New York State Department of Public Health's (CDC) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 15, 2020)
02/04/2020 Centers for Disease Control and Prevention's (CDC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC) Healthcare Providers Patients IFU Letter Granting EUA Amendment(s) (March 30, 2020)
Is that list wrong ?
Well you make a point there however the word “approval” is used on press releases . So I wasn’t really saying they are approved as much as I was saying the internet is saying that.
I guess the safest thing to say here is Cellex is one cut above the rest at the minute?
Perhaps there’s another level of “approval “ above what CELLEX has?
So perhaps CELLEX is authorized and no one else is ?
Whatever words we use, CELLEX is ahead of the pack one way or the other