Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
IP, this is for you .... If any broker, dealer or other person has any information that may relate to this matter, they should immediately contact Anita B. Bandy, Associate Director, at (202) 551-4746. The Commission appreciates the assistance of the Financial Industry Regulatory Authority.
UNITED STATES OF AMERICA
Before the
SECURITIES AND EXCHANGE COMMISSION
SECURITIES EXCHANGE ACT OF 1934
Release No. 88735 / April 23, 2020
The U.S. Securities and Exchange Commission announced the temporary suspension,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, of trading of the
securities of Decision Diagnostics Corp. (DECN) (CIK No. 0001144225), of Westlake
Village, California at 9:30 a.m. EDT on April 24, 2020, and terminating at 11:59 p.m.
EDT on May 7, 2020.
The Commission temporarily suspended trading in the securities of DECN because of
questions regarding the accuracy and adequacy of information in the marketplace since at
least March 3, 2020. Those questions relate to, among other things, (i) DECN’s
statements claiming to have “technology perfected” to allow it to manufacture and sell a
COVID-19 test kit that would provide results “in 15 seconds, based on a small finger
prick blood sample,” and (ii) DECN’s sales forecasts for the COVID-19 test kit that up to
525 million test kits would be sold in the first year of production.
The Commission cautions brokers, dealers, shareholders, and prospective purchasers that
they should carefully consider the foregoing information along with all other currently
available information and any information subsequently issued by the company.
Further, brokers and dealers should be alert to the fact that, pursuant to Rule 15c2-11
under the Exchange Act, at the termination of the trading suspension, no quotation may
be entered unless and until they have strictly complied with all of the provisions of the
rule. If any broker or dealer has any questions as to whether or not he has complied with
the rule, he should not enter any quotation but immediately contact the staff in the
Division of Trading and Markets, Office of Interpretation and Guidance, at (202) 551-
5777. If any broker or dealer is uncertain as to what is required by Rule 15c2-11, he
should refrain from entering quotations relating to DECN’s securities until such time as
he has familiarized himself with the rule and is certain that all of its provisions have been
met. If any broker or dealer enters any quotation that is in violation of the rule, the
Commission will consider the need for prompt enforcement action.
If any broker, dealer or other person has any information that may relate to this matter,
they should immediately contact Anita B. Bandy, Associate Director, at (202) 551-4746.
The Commission appreciates the assistance of the Financial Industry Regulatory
Authority
You can borrow my DECN Decoder Ring to sift through Bambling Berman's BS! SAD that this B_ _ _ _ R D can get away with this .... Weeks ago the virtual DECN IR, friend of MF Berman, would have been pounding on "flips" berating them and checking their "facts" .....silence OR as he would say, CRICKETS now!
HYPOCRITS! I guess GREED outweighs complicity in the CON .....Pump and Dump....Dirty Money OR whatever you want to call it......so much for the "Do Good" company line!
I hope KARMA is served and soon!
"LabCorp's Covid-19 At-Home Test Kit Gets FDA Emergency-Use Authorization
7:34 am ET April 21, 2020 (Dow Jones)
By Colin Kellaher
Laboratory Corp. of America on Tuesday said it received an emergency-use authorization from the U.S. Food and Drug Administration for its at-home test kit for Covid-19.
The Burlington, N.C., medical-testing giant said the authorization permits nasal-swab specimens to be collected at home using the Pixel by LabCorp collection kit if recommended by a healthcare provider after completing a Covid-19 questionnaire.
LabCorp said the self-collection kits will initially be available to healthcare workers and first responders who may have been exposed to Covid-19 or may be symptomatic, adding it plans to make the kits available to consumers in the coming weeks.
The company said enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduce demand for personal protective equipment."
The latest GRAPHICS of GenViro show use of the PRECISE meter yet the "original" PowerPoint shows the ADVANTAGE meter (saw neither in the actual market) and the claim, "FDA cleared for use with GenUltimate! Avantage! Meter"
PAGE 12 of Original PowerPoint
Product: GenViro! COVID-19 Screen
-PharmaTechSolutions sensors for screening the Coronavirus
-FDA cleared for use with GenUltimate! Avantage! Meter
-PharmaTechSolutions is a wholly owned subsidiary of Decision Diagnostics Corp. (OTCBB:DECN)
-Types of Products: Home diagnostic and testing supplies
-Primary Customer: People concerned about the Coronavirus and consumers who have GenUltimate! Avantage! Meters.
-Typical Usage: 1 test to screen for COVID-19
Things always seem to be "fluid" (verbal/written diarrhea) with DECN as longs see the holes in the story (use the DECN Decoder Ring) .....misleading or just sloppy and inept......reminds me of the shell games on NYC streets before social distancing ....maybe DECN distancing would be a great investor safety recommendation, IMO?
A picture may be worth a thousand words BUT how many packaging pictures have been shown of products that do not seem to make it to market, brick and mortar retail sales ..... i..e. GenSure was internationally launched in Sept 2017 and yet to be seen in market as far as I know ..... Illusion or Delusion .....ONLY the Chief Excuse Officer knows for sure!
Here are classic "caveats to accompany DECN GRAPHICS of products as the song with the lyrics "tomorrow, tomorrow" songs in the background ....check for yourself http://www.pharmatechsolutions.co/products.html UNLESS ONLY shareprice matters .....
This product is currently still in development and not available for sale.
More information coming soon!
Will be available in 50 and 100 count boxes!
Available in select International Markets Only
Specifically designed for sale in India, Mexico, Central and South America. Not for sale in the U.S. or Puerto Rico.
Available in March 2020 in select International markets. Not yet for sale in the USA or Puerto Rico.
Coming up for sale worldwide. FDA cleared and EU CE approved. First a
available in USA and Puerto Rico.
This product is currently still in development and not available for sale.
Jelly Bean, here's another Press Release that wound up on the "side of a milk carton", IMO. More mysteries available on the "Nancy Drew goes to DECN" series ..... ROTF! Those who do not learn from the past often repeat it!
After Disclosing the Choice of Licensing Partner Last Week, DECN Receives Two New Accretive Propositions for Its Panacea GenUltimate! TBG
Thursday, August 8, 2019 8:55 AM
Company in the Sights of a Big Box Looking to Replace a House Brand(s) and an International Healthcare Entity Looking for a Worldwide Three Party Agreement
LOS ANGELES, CA / ACCESSWIRE / August 8, 2019 / Decision Diagnostics Corp. (OTC PINK:DECN) is a 17-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! ("Sunshine") diabetes test strip, the internationally launched GenSure! ("Feather") diabetes test strip, and its GenChoice! ("Ladybug") test strip now in FDA 510(k) prosecution. The company also markets its PetSure! test strip for the diabetic testing of dogs and cats, a diagnostic specifically designed to run on the market leading Zoetis Alpha Trak meter system and the GenUltimate! 4Pets Test strip and Avantage! meter a proprietary testing product for dogs, cats and horses that has been licensed to Fetch 4Pets, and the panacea GenUltimate! TBG ("Dragonfly") diabetes testing system, now awaiting a clinical trial slot in Korea.
After disclosing the choice of a licensing partner on August 1, 2019, DECN received:
On August 2, 2019, a new proposition from one of the original bidders in the process, where the bidder changed their proposition from an acquisition offer for GenUltimate TGB technology and the resulting products, to a non-exclusive licensing agreement of the same technology. This latest proposition was unsolicited. The proposition emerged from an entity in a channel of the industry known as “Big Box.” This revised proposition does not conflict with any of the known terms from the prospective partner disclosed first on August 1, 2019. If appropriate, terms will be disclosed in the upcoming Quarterly Report for 2Q 2019.
And on August 5, 2019 the company was contacted by a second original bidder, this time an entity originally solicited by the company. This proposition was delivered during a long conference call. If a deal is struck with this proponent it will be more complicated and more wide-ranging. One point discussed with this proponent was a three-way multiple product and technology licensing arrangement that will include the company’s chosen licensing partner. The company awaits receipt of the hard copy proposition.
Keith Berman, CEO of DECN, commented, “News releases are announcement vehicles and not the best avenues to discuss business opportunity. However, given the enormity of our upcoming license deal for both the GenUltimate! and GenUltimate! TBG test strip and the GenUltimate! Precise meter, when cleared by the FDA, and anything else that may emerge from the latest propositions, we felt it best to discuss salient details, especially for those interested parties that do not dig down into our Quarterly Reports. ”
DECN further reports that all prospective partners are renowned organizations, all with products and properties in multiple channels, and all players, past and present, in the diabetes space. Further, the company contemplates the GenUltimate! TBG licensing agreements to be made up of three components:
A cash payment for provisions of stand-still during the negotiation of a Definitive Agreement
A larger cash payment for exclusive rights and term
On-going and handsome per-box or per unit fees for a four or five year term
Mr. Berman concluded, “The completion of the licensing agreement for the GenUltimate TBG technology, which includes the highly precise test strip, and the meter, which we call the Precise meter, is a panacea event in the company’s history. Not only will we reap the rewards of an expected $100+ million 5-year agreement, but it appears that there is substantial interest from a “big box” looking for a certain house brand replacement (or upgrade), and even more recently, interest from a certain international party eyeing a multi-party relationship. There will be much to discuss on August 14, when we post our 2Q 2019 Quarterly Report. ”
Jelly Bean, what ever happened to below PR?
DECN Chooses to License its Genultimate TBG Technology to Perfectly Situated Partner, Anticipates Agreement Will Yield Revenue Stream in Excess of $100 Million Over 5 Year Term, Company to Retain its Intellectual Property
Thursday, August 1, 2019 8:55 AM
Company Also Announces That at the End of 2Q 2019 All Legal Issues Brought Against Shasta Technologies Were Settled, DECN Will Realize Significant Gain in 2Q 2019 Period
LOS ANGELES, CA / ACCESSWIRE / August 1, 2019 / Decision Diagnostics Corp. (OTC PINK:DECN) is a 17-year old, diabetes-focused bio-technology development firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! ("Sunshine") diabetes test strip, the internationally launched GenSure! ("Feather") diabetes test strip, and its GenChoice! ("Ladybug") test strip now in FDA 510(k) prosecution. The company also markets the PetSure! test strip for the diabetic testing of dogs and cats, a diagnostic specifically designed to run on the market leading Zoetis Alpha Trak meter system and the GenUltimate! 4Pets Test strip and Avantage! meter a proprietary testing product for dogs, cats and horses, and the panacea GenUltimate! TBG ("Dragonfly") diabetes testing system, now awaiting a clinical trial slot in Korea.
After a 90-day process where a number of propositions for the company’s GenUltimate TBG technology emerged, some solicited, some not, DECN has chosen to complete an arrangement whereby it will license its GenUltimate TBG technology to a single party on an exclusive sales basis. The license agreement as outlined will not include a transfer of the DECN Intellectual Property. The structure of the agreement between the partners will include a significant up-front payment for the exclusivity rights alone as well as healthy license fees that over a 5-year period will realize the full potential of the technology and product.
Keith Berman, CEO of DECN, commented, “The Company received a total of six different transaction structures inclusive of outright sale of the technology, arrangements that included non-compete covenants, two earn-out propositions, and eventually two licensing agreements. We ultimately chose the licensing agreement that left the company with the freedom to complete development and then sell our in-development GenChoice TBG and upcoming CGM TBG products.”
DECN will provide a detailed discussion of the company’s strategic decisions in the upcoming 2Q 2019 Quarterly Report, due in approximately two weeks. The company will also update again on the litigation with Johnson & Johnson.
Mr. Berman continued, “The licensing agreement for the GenUltimate TBG technology, wich includes the highly precise test strip, and the meter, which we call the Precise meter, is a major strategic milestone in the company’s history. Not only will we reap the rewards of an expected $100+ million agreement, but in doing so we will have changed the focus and business direction of the company from being a developer and sales organization specializing in the alternative diagnostics products market, what some call the “me-too” space, to a specifications provider and manufacturer of cutting edge diagnostics of our own invention. GenUltimate TBG is just the first of our enhanced products and technologies.”
DECN further reports that their new partner is a world renowned organization with multiple products in the diabetes space and with multiple companies under its banner. The company will make all applicable disclosures at an appropriate time -- but soon.
Mr. Berman concluded, “In addition to the big events in the company’s near term future, we have also taken care of other important business. In late June 2019 we accepted settlement with Shasta Technologies LLC that had involved litigation in three states; California, Minnesota and Pennsylvania. As a result of this global settlement and perpetual releases, DECN will now be able to account for our 2014 acquisition of the Shasta GenStrip, that we subsequently rebranded as GenUltimate. This settlement and perpetual release will give rise to a gain in 2Q 2019 and also an addition to the carrying value of our intellectual property portfolio. We await the accounting treatment, which is complicated, but because it also involves approximately $660,000 of post 2014 development and intellectual property and hard asset acquisitions associated with the development of our GenUltimate. The entire series of entries should result in gains in excess of $2.5 million. Not surprisingly these gains were not lost on our prospective licensing partner.”
DECN has more possible competition ……
Iran Guards Commander Claims Machine Can Detect Coronavirus 100 Meters Away
https://en.radiofarda.com/a/iran-guards-commander-claims-machine-can-detect-coronavirus-100-meters-away/30555927.html
Maybe MF Berman can travel to Iran to collaborate …. ROTF!
Be cautious with Bronco Berman at the helm....
https://foxbaltimore.com/news/nation-world/fears-of-wild-west-as-covid-19-blood-tests-hit-the-market-04-12-2020-155641766
BUYER BEWARE!
Automatic reply: EUA Template
CDRH-EUA-Templates
<covid19dx@fda.hhs.gov>
4:05 pm
To XXXXXXXXXXX
We acknowledge receipt of your e-mail.
Surprised MF Berman did not send out a Press Release when they requested the EUA Template and got the above listed Automated Reply from the FDA!
ROTF!
The key word you use is IMAGINE!
This company needs to get the word out on its work with COVID-19 testing!
I came across it by watching a Dr. on Foxnews.com who was participating in a finger stick blood test for antibodies. She did not mention the maker of the test, Chembio. I saw DPP on the device and Googled that until I found Chembio!
This looks great - Glad company is on Long Island .... NYC and Long Island can use this testing asap! Yes, I bought a few shares AND hope this is a partial solution for combatting COVID-19 BUT people have to know it exists and soon!
GOOD LUCK!
COMPETITIVE INFO - April 1, 2020: "Shares of Chembio Diagnostics, Inc. (NASDAQ: CEMI) got a boost, shooting 39% to $7.10 after the company said it has launched in the U.S. the rapid DPP COVID-19 serological point-of-care test for the detection of IgM and IgG antibodies."
BTW Keith Berman, you great wordsmith, what the hell is the "seminal second step"? Here's a hint! IT MEANS NOTHING!
MF Berman must like the word, "seminal" .... he has used it before .... IMO, a vocabulary builder or word of the day book opened to that word.... 2018 was to be a seminal year .....How did that work out for DECN shareholders? SPOILER ALERT, it did NOT!
BUYER BEWARE! Use the DECN Decoder Ring with DECN propaganda
Matthew Musho ….is this the person MF Berman cites in the Press Release as "my primary consultant, who came out of retirement to create the design drawings and commentary" AND in the Annual Report, "As quickly as it could the company engaged Matthew Musho, PhD"?
STRANGELY(Well, not really for MF Berman, IMO), is this Matthew Musho the same Matthew Musho that was the President of Conductive Technologies, Inc. (CTI) that Shasta and CTI per the DECN Annual Report states alledgedly "colluded" with Lifescan. This would have caused harm to DECN and its shareholders? ACCORNING to LinkedIn and Matthew's profile, he was employed by CTI from Jan 2008 – Oct 2016 AND served as President and on the BOD.
On the iWel website https://iwelmed.com/management-team/ , he is listed as VP, Research & Operations and his profile states, "Matthew K. Musho, Ph.D., is a scientist and an executive with more than 30 years of experience in the IVD industry. He holds a doctorate in Physical Chemistry from the University of Notre Dame. Prior to his current position he was president of Conductive Technologies, Inc. (York, PA), a contract manufacturer of in-vitro diagnostic devices and printed electronics. Before arriving at CTI he was employed by the Diagnostics Division of Bayer Inc. (Elkhart, IN) in their R&D group. He is listed as a co-inventor on more than 20 patents."
INTERESTINGLY, the Annual Report states a not so friendly relationship with CTI in the past …..
"As a result of a product embargo by Shasta and Conductive Technologies, Inc. the company ran into an inventory shortage, and in fact ran out of product on several occasions. However, the inventory problem began to clear up in late May 2016, and with the advent of adding the GenUltimate! product from Korea, shortages were alleviated."
"In November 2018 the company filed a lawsuit in Pennsylvania court against Conductive Technologies, Inc. (CTI) and Shasta Technologies LLC, alleging, among other things, that these two former partners colluded along with Lifescan, Inc. to illegally embargo the company’s GenUltimate! product and technology, and to attempt to seize this product and associated Intellectual Property."
Is this a case of "strange bedfellows", REDEMPTION or dealing by the devil with another devil?
I smell another nice class action lawsuit coming against Bozo Berman, just think, if that happens his tax returns can be subpoenaed.
I, along with many others, IMO, will enjoin such a suit.....DISCOVERY will be very interesting!
What happened to PARAGON? It has been over a year since the "4 year agreement" was signed ....Walmart, CVS, Kroger assigned....NADA on store shelves ....is the relationship still in place or did it go the way of the Mexican deal and the Bolivian deal before that .....
What happened wiith Fetch4Pets? Pet retail brick and mortar sales was to happen and even mentioned when items would be distributed? Was this a distributor or a license agreement? If license agreement, did DECN benefit or did MF Berman make a side deal somewhere?
IMO, MF Berman is a DISASTER of EXECUTION. Sad, he cannot recruit and retain a qualified Board of Directors .... he needs the help, IMO for sure!
Only his ARROGANCE outshines his managerial INEPTNESS, IMO! He should stick with legal and development matters and recruit a qualified CEO who understanding marketing, sales and business development and does not bath his/her-self in business BS!
NOBEL prize, my arse!
BUYER BEWARE!
WOW! Excellent post ... a MUST read for any potentioal, current or past shareholder, IMO.
MF Berman needs to be held accountable, IMO. Hopefully, criminally, civilly , or via just karma....there is a major difference between making a poor investment and being conned!
I am sure he sleeps soundly as he is probably callous to the ills he has caused directly and indirectly, BUT he shouldn't have any peaceful sleep! IMO, he has betrayed public trust.
IF we ever have a Shareholders' Meeting, I will attend just to look into his eyes one on one, BUT I am sure the coward and con will avoid such a public viewing by shareholders at all cost.
BUYER BEWARE! IMO, The CON lives ON!
"much goes over peoples heads" with DECN press releases, IMO - I agree with you 125% and IMO, it is deliberate!
I have a concept and hope to finish detailed specifications leading to advanced development of the DECN Decoder Ring to be projected to save unwary investors from catastrophic losses sometime in the future but not today, tomorrow or ever ... further discussions to follow. Information coming soon! This product will not be sold in the U.S. and Puerto Rico nor anywhere as a matter of fact.....so I hope you forget about it following the silence regarding its status.
PLEASE do NOT hold your breathe waiting for this product.
BUYER BEWARE!
Yes, the absence of results in the diabetic arena has been covered over by the hype of the DECN Coronavirus claims.
I wonder if of any DECN IP, if real, has benefited overseas relationships and MF Berman, the Chief Excuse Officer, rather than DECN shareholders? A coincidence that MF Berman is on the South Korean Partner's BOD yet diabetic test strip sales by DECN are so paltry? Many of the activity for testing has come from South Korea. China is known for forcing companies to share IP with them ....has this been the case during talks when MF Berman said DECN would manufacture in China?
IMO, MF Berman cannot be trusted in anything he states. The average person cannot fully interpret standard PR's without a DECN Decoder Ring as, IMO, they are vague, full of exaggeration, hype, and doublespeak ....far from being clear and concise!
Many NEW DECN investors will learn the hard by "believing DECN at face value" just as I did with the Davy and Goliath stories in regards to DECN and JnJ 4 years ago. The ONLY real claim to being a "leader" by MF Berman, IMO, is playing on the sympathies and hopes of hard working people to "believe." IMO, MF Berman is a low-life con .... IMO, his behavior capitalizes on the belief that "there is a sucker born every minute!" IMO, he has betrayed public trust and there is a difference between making a bad investment versus being conned.
BUYER BEWARE!
MF Berman does not deserve nor has he earned "credibility" based on his past performance and "reputational risk", IMO. You yourself have been critical of his performance and press releases full of hype and items that never come to be ….I do not put it past him to take advantage of the coronavirus for his own gain and that of his close associates …. YES, I HOPE everyday, as I have in the past since getting into this INVESTMENT 4 years ago, his claims are true; HOWEVER, I am doubtful. These current claims and press releases may have been his reach too far and if so, I will pursue all means of justice. IF his claims come true, I will GLADLY give credit where credit is due.
BUYER BEWARE still stands …. There is an expression, "NEVER FORGET" and it applies, IMO, to this experience with MF Berman and the IR, esp the IR! I have had personal contact with MF Berman early on my association with tis investment and he is NOT a nice person, IMO.
Finally, another expression to close with, "Those who do NOT learn from history are often doomed to repeat it"
California Company Under Scrutiny For 'At-Home' Coronavirus Test Claims
https://www.npr.org/2020/04/02/824437247/exclusive-california-company-under-scrutiny-for-at-home-coronavirus-test-claims
https://www.justice.gov/coronavirus
The Department of Justice is remaining vigilant in detecting, investigating, and prosecuting wrongdoing related to the crisis. In a memo to U.S. Attorneys, Attorney General Barr said, "The pandemic is dangerous enough without wrongdoers seeking to profit from public panic and this sort of conduct cannot be tolerated."
Be aware that criminals are attempting to exploit COVID-19 worldwide through a variety of scams. There have been reports of:
• Individuals and businesses selling fake cures for COVID-19 online and engaging in other forms of fraud.
• Phishing emails from entities posing as the World Health Organization or the Centers for Disease Control and Prevention.
• Malicious websites and apps that appear to share virus-related information to gain and lock access to your devices until payment is received.
• Seeking donations fraudulently for illegitimate or non-existent charitable organizations.
Criminals will likely continue to use new methods to exploit COVID-19 worldwide.
If you think you are a victim of a scam or attempted fraud involving COVID-19, you can report it without leaving your home though a number of platforms. Go to:
Contact the National Center for Disaster Fraud Hotline at 866-720-5721 or via email at disaster@leo.gov
Report it to the FBI at tips.fbi.gov
If it's a cyber scam, submit your complaint through https://www.ic3.gov/default.aspx
Another source of questions/investigation should be with www.fullcirclediabetes.com and Ms. Bender who was an employee of DECN and owner of Full Circle Diabetes …..a "distributor" for DECN/Pharma ….FOLLOW the money ….let's not forget about MF Berman going on the Board of the South Korean "partner" ….Vendor and Customer relationship.....any conflict of interest? ….. I am sure there are many skeletons if properly investigated!
There is a virus other than coronavirus that instead of quarantine, requires incarceration …. MF Berman and CREW!
Would love to see Berman and his IR/Apologist held accountable - FINRA or esp now the DOJ may be interested - I am sure there are many other shareholders and former shareholders that would enjoin/cooperate. PM me!
This was from page 12 of the "presentation" which may become an "Exhibit" ….ROTF!
Product: GenViro! COVID-19 Screen
-PharmaTechSolutions sensors for screening the Coronavirus
-FDA cleared for use with GenUltimate! Avantage! Meter
-PharmaTechSolutions is a wholly owned subsidiary of Decision Diagnostics Corp. (OTCBB:DECN)
-Types of Products: Home diagnostic and testing supplies
-Primary Customer: People concerned about the Coronavirus and consumers who have GenUltimate! Avantage! Meters.
Typical Usage: 1 test to screen for COVID-19
I am a long that is here ONLY because of high entry SP. IMO, this has always been a company based on hype, exaggeration, non-execution, excuses, betrayal of public trust and worse!
SAD! Lost opportunity .... the Wizard of Con! You need a DECN Decoder Ring to REALLY understand the PR's, IMO!
This, IMO, is an example of bad people getting away with it! Can only hope karma and/or justice catches up with all involved!
Yes, bitter and deservedly so!
FDA clears Bodysphere 2-minute COVID-19 test
MARCH 31, 2020 BY SEAN WHOOLEY
Bodysphere announced today that it is initiating the distribution of its two-minute testing kit for diagnosing COVID-19 after receiving FDA emergency use authorization.
The Los Angeles-based company’s two-minute testing kit uses antibodies in blood to test for current or past infection with a 91% clinical specificity rate and a 99% clinical sensitivity rate, according to a news release. The test delivers results on-site in as fast as two minutes.
Bodysphere’s test is a lateral flow chromatographic immunoassay to detect antibodies (IgG and IgM) for the coronavirus in human whole blood/serum/plasma. It is only for administration by medical professionals.
The company said its test kits have already been successfully used in multiple states where large rollouts are in the works for combating the spread of the virus. Bodysphere added that it is working with federal agencies and states to quickly deploy test kits where they are needed.
Bodysphere said it has contracted cargo planes to deliver the product to the front lines and touted its capability of having millions of test kits reach those front lines within weeks.
“When we realized we had the ability to step up and fight this pandemic at a critical point, we focused all our resources on bringing the rapid test kits, masks and other critical supplies to the front lines as soon as possible,” Bodysphere CEO Charlton Lui said in the news release. “Thankfully when our perpetual quest for improving health put us in a position to deliver this lifesaving product – it became quite clear what we had to do.”
GenViro!
The design above is in many regards similar to the direct antibody antigen approaches favored by some of the competitive companies in the Covid-19 testing field. But the major difference (magic) is that the approach used by the company in its GenViro! product allows for swift (15 seconds or less) results using a minimum of blood from a finger prick. As of this writing, work has commenced on the product specification above with components such as the platinum electrodes, platinum carbon paste, industrial films (several types) to make the biosensor, and perhaps a new impedance chip for the meter. The company is operating on an 8-week development schedule and is some 10 days into this schedule. The current development cycle is considered advanced development. For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company is preparing its final working concept filing, to be completed within days of this writing.
On April 1, 2020 the company plans to begin development work on its second product design, a confirmation test for Covid-19. This test, a hybrid but direct antibody/antigen (IGG) method, again making use of the company’s expertise in biosensors, will be designed to be used on those the tested Positive Covid-19, and those that tested Negative but are suspected to be false Negatives. This product design is not yet in the advanced development cycle.
The DECN Theme Song, "Tomorrow, Tomorrow …."
Abbott Launches Molecular Point-of-Care Test to Detect Novel Coronavirus in as Little as Five Minutes
ABBOTT PARK, Ill., March 27, 2020 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.
What does 'FDA cleared' mean?
Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.
For instance, let's say hypothetically Samsung wanted to create an app that can record a singlechannel electrocardiogram (ECG, aka EKG), which is what Apple's ECG app does. It could get FDA clearance if it can compare its product to Apple's and demonstrate that it is safe, effective and equivalent in how it works.
Companies must submit a "premarket notification submission" or 510(k) to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.
The above is from https://www.cnet.com/news/fda-approved-vs-fda-cleared-whats-the-difference/
3/26/2020 - "California man arrested by FBI, charged with coronavirus related fraud"
A Southern California man was arrested for allegedly soliciting investments in a company he claimed had developed a cure for COVID-19, according to a statement by the Department of Justice on Wednesday.
It is great the DOJ will prosecute those who attempt to take advantage and/or break public trust on the coronavirus scourge!
EUA - Emergency Use Authorization - FDA Website - Lists current EUA's - Does NOT show Application Status - DECN is NOT Authorized as of this post - Roche is listed and a copy of the Letter informing of the EUA is available for review.
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
There is a page entitled, "How to Submit a Pre-EUA for In vitro Diagnostics to FDA … Pre-EUA information for manufacturers of IVD tests"
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda
New Product in Delevopement - Information Coming Soon! - Not Available in the United States or Puerto Rico - Available in Select International Markets, When and If it ever comes out of the Development Stage - Delivery Expected sometime in the future - Manufacturing Capacity Increased to handle production to compete in $10B Market - Deemed a Do Good product - Available for Private Label - Licensing business model anticipated - Will be a tertiary revenue stream - Testing to start soon - Looking for BS Distributors - Leading Manufacturer of BS!
GenBS - Detects BS in less than 2 seconds versus legacy years of review of PR, Reports, lack of execution and other exaggerations.
Testing will be at Ground Zero for BS - Westlake Village and related associated sites!
When you string all the statements together, sounds a but funny, if not so sad!
Don't become a victim, use GenBS to be BUYER BEWARE approved!
"Nothing to worry about for longs."
ROTF! MAY 2016 SP .53 .... Only thing longs have seen since then is, IMO, dilution, shareprice down 90%, a trail of unexecuted statement by DECN, still no DECN product on big pharma, pet store or retail shelves, no private label sales, no executed license agreement, continued exaggerations and DECN spin from the Chief Excuse Officer and so many more examples of ineptness, etc.
BUYER BEWARE!
GeneSig ..... COVID-19 ...."Available for worldwide shipping NOW"
https://www.genesig.com/home
MF Berman, get back to getting Diabetes Testing products on store shelves, licensed, worldwide distribution, etc as you have stated for years .....RESULTS NOT RHETORIC!
.53/share
A "prank" is for fun, BUT this impacts REAL people or IMO, REAL victims! I get your drift and can only hope one day all involved get Karmic justice for IMO, their transgressions!
I am sickened that people can get away with such, IMO, deceit. They are no more above the nutshell or card sharks on any city street con.
SAD! SHAMEFUL to prey on people in such a way, IMO!
CLASSIC DECN and MF Bermman distraction, IMO! Longs get NOTHING in this pump because the SP has been eroded so much since May 2016.
Where is the licensing agreement? Where are the perfect partners? Where is the Feb 17th launch? Where are the products on 2,000 store shelves? Where is the EU approval? Where is the Russian Federation? Where is the Annual Shareholders Meeting Info? I would love to tell MF Berman and either his alter ego pen name or DECN Hack they are full of crap to their faces!
IMO, this has been and will always be a SCAM! A true violation of public trust and takes advantage of people who "believed"!
SICKENING COWARDS!