I am new to this board, but DECN caught my attention a few weeks back. From the limited reading of people posting on this board, there seems to be quite a bit of confusion or mis-information regarding the claims and timing provided by the company, so I have reread all the PRs released since their announcement of getting involved in COVID-19 testing pursuit and taken out quotes from those PRs for those wanting a summary review of what the company has said.
One important factor to clear up. The initial projection provided of 425M units over the course of a year beginning in Sept 2020 chart should be taken down or given an asterisk because that all changed when the FDA changed the rules for EUA. The company has made clear that they anticipate initial roll out of 250,000 test kits in May 2020 and that the change in FDA rules cuts out months of development time for the products approval. Once and if they pass the FDA data testing guidelines given after the PRE-EUA approval letter, they would be able to manufacture, sell and distribute immediately. They anticipate that happening in 2nd Qtr now, not 3rd Qtr of 2020 which is a game changer in my opinion for the near term potential of this stock. The day (if) they get FDA EUA approval, this stock goes over $1.00 and doesn't look back.
According to info in the PRs, they have designed and tested the kit in Daegu, South Korea already and therefore are confident of the success of their kit application testing for the FDA. They have not yet manufactured or offered the kit to other countries as yet as they tweaked their design up until early April, but it is now finalized.
Here is the historical company PR information I base my outlook on which is taken directly from quotes of the PRs cited below. Hope this helps everyone new to the company or board. This stock has a bright future if they succeed.
March 16 PR (1 of 4 announced)
“Our product, introduced to the world only 14 days ago has entered its crucial development stage. We are awaiting release of blood samples from previously infected people in Daegu, Korea, so that we can complete testing and make a final report to the U.S. FDA so that we may secure our Emergency Waiver. In the meantime, all other requests made by the FDA will be met this week and next. Further, we will engage in the EU with administrators of the ISO standard CE regulatory process this week. Only two diagnostic methodologies have been approved in the EU, none with the cost effectiveness or promise of GenViro! Our plan is designed to bring at least 100,000 of our kits to market in the USA and Canada, and another 100,000 in Europe, during the month of May 2020.
…We expect the vast majority of the 420 million test kits we plan to manufacture in the first year of production will be sold to individuals for self-testing."
March 17 PR (2nd of 4 announced)
DECN'S GenViro!(TM) Corona Virus "Swift" Kit, Now to Be Additionally Offered to Commercial Labs and Religious Groups as 12 Month Forecast is Raised to 525MM
“Mr. Berman concluded, "As you might imagine with a product announcement of such importance, we have been contacted by a number of potential partners for our kit. To date we have discussed our GenViro™ product with a big box pharmacy chain, a master medical products distribution company, a large commercial lab, and a home health organization. All of these entities want the kits and we intend to write their business.
We are not resting our laurels with our GenViro development. Later product entries will be test methods for Polio, Ebola (Marburg), Bird Flu, and SARS.”
March 18 (3rd of 4 announced)
“On March 16, the FDA updated its COVID-19 test policy. A significant change to this policy is that once validation testing for a product has been completed, the test can be distributed to customers, entities and users, with certain labeling and a summary of test results provided on the company website (and/or the package). GenViro!™ has been validated at the company's R&D center in Daegu, Korea for the H5N1 virus and most recently the methodologically similar corona virus.”
“…While the company will still need to provide ample data and a full discussion of its unique technology in the coming days, the new FDA policy will provide a channel that will allow the company to manufacture test kits and put these kits into distribution almost immediately. This same unperturbed policy will also allow us to quickly add our second GenViroTM product designed for hospitals and for clinics and commercial labs desirous of a confirmatory method for those who test positive for coronavirus."
Mr. Berman concluded, "I have been in and around the in-vitro diagnostics business for over 40 years, and never before in all of that time, have I witnessed a policy like this. This latest guidance from the FDA shaves months from our product development process, and we all shall reap these benefits. Tomorrow we will discuss our new plans going forward now that we will shortly be a two product coronavirus diagnostics company."
Personal NOTE: The March 17th PR which updated potential sales of kits in first year at 525M units was based on a projected sales beginning in Sep 2020. The FDA change of policy on March 16 DECN claims will shave months off its projection and they anticipate distribution of initial test kits to begin in May 2020. That is a big deal.
March 20 PR
DECN to Finance 2Q 2020 Roll Out of its GenViro! Covid-19 "Rapid" Kits Using Non-Dilutive Debt Financing Totaling $13 Million Acquired in Near 0% Rate Environment
“Today, DECN announces that the company's Board of Directors has approved the offering of $13 million in non-dilutive debt financing, the first $2 million in Notes, followed by a $1 million credit facility to purchase manufacturing equipment for their Korean manufacturing facility, and the remaining $10 million in a revolving line of credit to finance inventory. Each of the three offerings are already subscribed to.”
Personal Note: After FDA 3/16 policy change, DECN is changing product availability/roll out from beginning in Sep 2020 to 2Q 2020. The only steps to pass for them is the FDA validation data of the test kit before they can manufacture with immediate distribution.
March 23 PR
DECN Finalizes FDA Pre-EUA Version of Its Genviro! Screening Covid-19 Swift Kit, Providing Results in 15 Seconds Using Only 1.0-2.0 Microliters Whole Blood
COMPANY'S EMERGENCY USE (EUA) APPLICATION TO BE UPDATED IN THE NEXT WEEK AS MANUFACTURING SPECIFICATIONS FINALIZED, DISCUSSION OF GENVIRO! UNIQUE QUALITIES ENSUES
“Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip that will go into production just as soon as the FDA grants emergency status to the DECN product. The company's methodology employs a simple, easy to use, swift (15 seconds and faster than Rapid) method for determining the presence of a virus in blood lyced into blood plasma.”
“The method is safe, effective, and its biggest benefit to the healthcare system is that the device can be used to screen out the 97% or 98% of those tested that are negative for COVID-19. Our method is quicker, provides the desired result, is much cheaper, and effective.”
“GenViro! is not a Serology methodology.”
Personal Note: So this first rapid test kit or “Swift” is not a test to detect antibodies or whether the person was exposed at some point to the virus. Stated in previous PR, their test is designed to detect the virus itself as I read it.
A 2nd kit under design, will be a serology based kit:
"DECN is also creating what we call our affirmation test, a kit that will affirm a positive reading from the GenViro! Screener. Similar in nature to the GenViro! screener, and readable by the Avantage meter, the affirmation test will be serology based, but will use our unique and charmed electrochemical impedance spectroscopy. We anticipate being tens of millions of GenViro! kits down the road when our serology version of Genviro! is completed.”
Personal Note: This 2nd kit was confirmed with more detail in March 23rd PR:
“This second kit will begin assembly for internal testing on April 1, with availability in late summer 2020. The method will again use a Biosensor (test strip-like device) and the company's Precise meter.”
“As this week goes on we will present a summary discussion of those specifics and issues we have considered in the past 21 days, a truly remarkable time for the company. We are truly thankful that the private sector, the Federal government and foreign governments are showing extreme interest in out GenViro! products. We have many more accounts to present."
April 6 PR
“…announces today that the company has filed its formal and finalized Emergency Authorization for its Professional Use Covid-19 screening kit with the Emergency Authorization review group at the U.S. FDA. The application was filed on Friday 4/3/2020 late in the afternoon, acknowledged less than three hours later, and assigned for EUA review on Saturday 4/4/2020. There have already been several contacts between the FDA EUA review group and the company's FDA counsel.”
…"Our Korean partners, my primary consultant, who came out of retirement to create the design drawings and commentary, our FDA lawyers, and our own employees and those of our Korean partner jumped all over our efforts in what became a fundamental initiative. The application we filed with the FDA last Friday is our first fulfillment of these efforts, after weeks of internal and external discussion, planning, designing and redesigning and finally completion of the method design.”
April 7 PR
DECN Receives Pre-EUA Acknowledgement Letter And Product Serial Number From U.S. FDA For GenViro!(TM) Covid-19 Screening Kit For Professional Use
“DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020. Later on this same day FDA counsel had several exchanges with FDA EUA staff. In one of those exchanges, the FDA provided Guidance for our final product testing.”
“As early as Saturday April 4, it was clear that the FDA review staff was aware that our methodology was different than those slower and older methods that had received FDA EUAs, or were in review. Although the testing requested will be rigorous, it appears that testing will require 30 known Covid-19 positive samples and 30 known Covid-19 negative samples, all samples based on venous blood. The company is now looking to contract with a hospital or commercial laboratory to complete this testing.”
“The company plans to discuss in the coming days how we intend to identify the various coronaviruses through GenViro!™. Reading that discussion will be a unique opportunity. The method the company intends to use will be based upon earlier products shepherded by Messrs. Berman and Musho. We expect industry people will be surprised.”
