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.
Further from Rethink My Healthcare, they are selling each unit test kit for $40 (purchasing for $17.50 from WORX and reselling for $40) with a minimum order of 250 test kits, only to medical and law enforcement professionals.
Their website states customer must pay at least 50% of order up front and billed the rest.
This is how it is working for them to be able to place orders even without their own stacks of cash.
On the conference call he said the manufacturer was not in China or South Korea. This aligns with the fact that the large order coming from Rethink My Healthcare for the rapid tests they are advertising and selling via their website COVID-19 rapid test for sale are for a test kit manufactured by Promedica in Australia.
You can look it up and review the brochure. This must be the kit for which they placed an order via WORX. WORX is the middle man supplier/distributor who will order these kits and more on behalf of not only Rethink My Healthcare, but any other customer in the WORX network.
Conference Call outlook:
After listening to Conf Call Listen to posted audio of today's Conf Call, I have no reason to believe this is a scam. WORX has a computer system that I'm not expert on, but seems to connect hospital information and help hospitals and others manage needs for products.
WORX has set up a "hospital Escrow account" for its customers whereby they can deposit funds so that WORX can negotiate and order on a large scale the various PPE and test kits in demand as a result of COVID-19. Therefore, they are not using their own Cash, they are acting as an intermediary (like a contractor) to aggregate funds, create POs on behalf of their customers and advance Pre-Pymt funds to manufacturers and others providing the supplies.
They confirmed that Rethink My Healthcare has put in PO for 2 million of the Australian manufactured COVID-19 blood test kit which according to the brochure is not perfect, but has over 90% accurracy on different results and has been approved for use in Australia. The manufacturer is guaranteeing WORX up to 25% of their manufacturing to fill test kit orders.
If WORX is not driving up product pricing abnormally, I don't see any SEC issues here at all other than the gov might be interested in validating the kit and the supply chain, which seem intact.
The $35 million order for 2 million kits puts the purchase price at $17.5/kit to Rethink My Healthcare. Don't know if that is price gouging or not, but probably has a nice profit margin of 10% or more for WORX, like a contractor fee. 10% of $35 million weekly, if they are able to procure and distribute, would mean $3.5M possible revenue for WORX over X weeks.
Don't understand the screaming of fraud here. He said first shipment of test kits to arrive in 2 weeks, which means this is worth keeping eye on. Everyone will know soon enough whether it materializes or not.
Need clarification.
Your post states the Covid-19 test doesn't exist.
NEITHER entity has enough cash-on-hand to blow out a birthday candle- yet "claim" they're going to do $10's and $10's of MILLIONS in fantasy "purchase orders" for "COVID test kits" that DO NOT EXIST.
Just to confirm. You did check the website yesterday and this paragraph was not there?
My impression was that it was referring to the series of scheduled 4 PRs over the past 3 weeks.
FYI - GenViro test kit does not seem to be an antibody test, but rather is going to identify presence of the virus. They are designing a 2nd test kit as an antibody confirmation kit.
DECN has a slideshow presentation on their website with the basics of the science behind their test kit design if anyone is interested.
Link: GenViro Slideshow
Thanks GeoMoney1 for the posts and links to articles. Why isn't AYTU jumping on the news? My guess is:
- National news briefing putting doubt on reliability of many anti-body tests
- I couldn't find AYTU listed on CDC yesterday for companies providing anti-body testing (thus limited exposure thus far)
- Initial orders reported by AYTU are for small quantities and one of the articles in your links mentions that a local hospital only ordered 1,000 tests initially to do their own validation before rolling out a larger order since AYTU's own lable only shows a data set of 123.
- Today's PR states they haven't received the next 500,000 and it doesn't confirm that those 500,000 have been sold.
While I think/hope these are only temporary delays to the stock taking off, what will bring in large buyers is when they can issue a PR that multiple sites have validated the test kit results with a much larger data set. (Hopefully they have an ongoing relationship with the hospital testing 1,000 kits and if that provides data confirming the test kit specificity and results that are currently on the label, then I think the large orders will come in as well as the investors.
Also, if they release a PR confirming the 500,000 are actually sold, that would also be a big deal and you'd see the price gains we are hoping for.
Patience is needed a little while longer.
AIMO
Thanks.
Seems like AYTU has recently updated/revamped their company website, but what I would really appreciate seeing is a clear update as to the shipments of 500,000 test kits and how many have been sold to date and just need to be shipped etc.
Have they even sold out of the first shipment? From prior PRs it seemed that all of the first shipment of 100,000 were already requested and they were ordering much larger shipments because of interest/requests.
That was over a week ago. Time for an update.
Anyone have a simple answer as to why a film company buys an almost defunct "scientific" company?
Something to do with avoiding paying taxes on film income for ages to come because of BMSND debt?
There have been posts claiming there is no "proof" or the science is questionable. I'm not a scientist, but it is worthy to note for others on the board that in the supplemental disclosure document filed on March 30th and quoted in my longer post this portion: In all three cases the researchers designed and built a bench level chemistry methodology and their version of an identification device, and then performed tests on live patients. In all cases the number of patients (subjects) tested was statistically significant. The importance of these publications indicated that a testing device and chemistry method, using impedance (better described as an energy pulse with traits somewhat similar to an electric current and a radio wave pulse), could be created in short order to measure the presence or absence of such a virus (of interest) such as influenza and H1N1 influenza, and of course SARS and Covid-19.
So in their filed documents they are stating that the science their test kits are based on has been tested on live patients and with a statistically significant number, which is why they are putting all their resources and efforts into these new rapid test kits, confident that they will work.
I cannot verify or deny such claims, I'm just passing on what they have filed with the government recently and why they have given the outlook they have given.
Everyone read, weigh, and wager accordingly IMHO.
Happy to contribute to the discussion.
Updated: Brief History of Recent PRs along with Supplemental Document filing of March 30th.
This is an update to a previous post provided to help people new to DECN get a quick overview. 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.
[Update] Taken from the Supplemental Disclosures filed on March 30, 2020 with the annual report. [starting p 15] From Overview of how they came to design a COVID-19 test:
"we received three cites from The Bio regarding technical papers written in the last five years where the researchers and scientists discussed in those white papers the ability to use a method called impedance to identify and classify certain (now familiar) classes of virus. All three papers described their methodologies in detail and included sample data sets. In all three cases the researchers designed and built a bench level chemistry methodology and their version of an identification device, and then performed tests on live patients. In all cases the number of patients (subjects) tested was statistically significant. The importance of these publications indicated that a testing device and chemistry method, using impedance (better described as an energy pulse with traits somewhat similar to an electric current and a radio wave pulse), could be created in short order to measure the presence or absence of such a virus (of interest) such as influenza and H1N1 influenza, and of course SARS and Covid-19. The company’s GenUltimate TBG product makes use of impedance technology to measure the number of red blood cells in a patient blood sample, information relevant to a glucose measurement in that same patient. Mr. Berman, the company’s CEO, became convinced that a similarly configured device could be built for the determination of Covid-19. As quickly as it could the company engaged Matthew Musho, PhD (holder or collaborator in 32 patents published in parallel fields) and his wife Leslie to assist in the design of a testing method and device for the measurement of Covid-19."
"...The specifications guidelines set down by Mr. Berman, for creating this Covid-19 testing device and its important chemistry, were that the test must be measured on the company’s existing Precise or Avantage glucometers, because they were completed products, having been tested to great length, and now to be adapted for detection of Covid-19 instead of whole blood glucose. In addition, the resulting chemistry would necessarily run using a patients (small sample of) whole blood taken from a finger prick, and later defined as 1-2 microliters (a small drop on a finger tip), and perform the test and provide a result in one minute or less (later redefined as 15 seconds or less), with at least a 95% accuracy. Mr. Berman believed this device was capable of 97-98% accuracy. Three alternative designs were provided and given to the company on March 2. Two of the designs were diagrammed by Mathew Musho, PhD, the third design by a chemist and engineer from The Bio in Korea. The chosen of the three alternative product designs would bear the trade name GenViro! Swift."
On page 16 they provide graphics as part of the final design they have chosen out of the 3 proposed.
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.”
Don't know what you are getting back at.
Science is based on theories and testing, laws of nature and induction/deduction rationale.
They have a testing system and a few scientists wrote papers based on their observations and scientific testing as explained in the overview of the Supplemental Document cited.
We are in agreement that we do not know for sure whether the COVID-19 impedance test kits will work and if so, whether or not it will be at the above 95% accuracy they expect.
What we know and what I have quoted/stated in my posts is that they have an FDA approved testing platform and background in impedance testing for a few different products. The scientists they conferred with for designing a COVID-19 test kit believe it can be done and that it will be accurate and quick. Based on that, the company has stated that they have secured funding etc. etc.
I cannot personally verify it and it's not my place to do so. If you can verify that all of it is false, based on personal knowledge or contacts, I welcome the data.
Otherwise, we both have to wait and see, no?
Any SCWorx is not even the manufacturer of the test kits. They are just a middle man acquiring the test kits from someone else.
Hundreds of millions of test kits will be needed far beyond current manufacturing capabilities.
The PR from them today shows the need and potential for anyone able to manufacture a decent test kit and if DECN is able to produce a decent 15 second kit, it doesn't matter how much market has been taken over by the 15 min kits, a 15 second kit is going to start taking over.
Let's hope the science they have is validated.
Sorry. I don't see much of value in the quoted posts. When people have to resort to totally disallowing anything of value from a person or company, it just reveals that they are really not depending on the facts of their statements carrying enough weight.
I ask the question once again: Does anyone have proof or hold that the platform that they have for glucose testing is inaccurate or invalid?
They have laid out in diagrams within their press releases what their tests are hoping to achieve and why it would work. The science is not from Berman. Berman laid out the prerequisites of how any test for COVID-19 based on the white papers would have to be designed and work with their established and tested platform.
They believe they have a valid design. Those you quote I have no idea of who they are, but resorting to just bashing people doesn't prove anything to me.
I don't know if the design will work or not. They believe (are confident) their test kits will work based on other testing. We shall know relatively soon (within several weeks) whether or not this moves forward or hits a dead end. If it moves forward, it won't stay anywhere near this price. IMO
I'm not saying anyone should put their life savings into this company. I do believe this offers a high risk/reward scenario.
Not really true. I recommend the Supplemental Disclosure document as further reading for those who want to know more about how this came about and what the test kit plans were based on. (Start reading on page 15 of this document:Supplemental Disclosures
Here is a quote from that document (and remember this document was posted March 30th, so it doesn't include the recent information given in PRs since then)
A few days later we received three cites from The Bio regarding technical papers written in the last five years where the researchers and scientists discussed in those white papers the ability to use a method called impedance to identify and classify certain (now familiar) classes of virus. All three papers described their methodologies in detail and included sample data sets. In all three cases the researchers designed and built a bench level chemistry methodology and their version of an identification device, and then performed tests on live patients. In all cases the number of patients (subjects) tested was statistically significant. The importance of these publications indicated that a testing device and chemistry method, using impedance (better described as an energy pulse with traits somewhat similar to an electric current and a radio wave pulse), could be created in short order to measure the presence or absence of such a virus (of interest) such as influenza and H1N1 influenza, and of course SARS and Covid-19. The company’s GenUltimate TBG product makes use of impedance technology to measure the number of red blood cells in a patient blood sample, information relevant to a glucose measurement in that same patient. Mr. Berman, the company’s CEO, became convinced that a similarly configured device could be built for the determination of Covid-19.
Thanks Rawman for the link to the Supplement Disclosure Document. Facts and documents are always welcome to the discussion.
I agree that there is no imminent distribution. That have stated that they have secured at least $1M for manufacturing equipment and the new test kits will be manufactured by their current partners who also have motivation to make it happen, being at one of the centers of Covid-19 in South Korea.
I am hopeful, but I have no track record with the company. The recent PRs altogether, point to a "potential" promising outcome. Companies like BMRA, trading above $8 talk about ramping up to produce 1M test kits a month. Well, that means 5 months from now that's only 5M kits. Abbott's weekly to monthly figures weren't extraordinary and if a vaccine is a year away and hundreds of million may need to be tested in a somewhat ongoing manner for the world to open back up to work, that means the market for test kits will not have been at all saturated by August.
So if you were going to a drive thru and at one drive through, the wait was 15 min for every "order" and another drive thru was serving up orders every 15 seconds, it seems likely the 15 second drive through would capture as much market as they could produce.
Berman has raised his initial target from 420M to 525M. What that is based on I don't know, but everyone should realize those numbers are based on a home test kit that is not yet on the screen for approval.
Still, given the price of the stock, the market not going away and the potential for sales of any rapid kits in the millions, I'm optimistic as to where this stock might be in Sept vs today.
In one PR, they did state that the test kit was proven in South Korea for both H1N1 and the coronavirus. I don't know how true that is nor how it came about, but it was in one of the PRs. So it seems that they are extremely confident their kits will work or they wouldn't be borrowing the money and ordering the materials I wouldn't think.
Thanks again for the link. I'll read that document.
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.”
Just remember, watching the ticker minute by minute or Level II trading, one can lose their overall perspective of price action.
A surge in orders that go up 10 cents in 5 min and then falls back 6 cents over the next 3 hours is only a 4 cent gain without sustained momentum even though while watching the 5 min surge it appears everyone is going to come and buy the stock.
While I appreciate the enthusiasm, you might not want to make too many predictions.
GLTA.
Okay. Breathe deep. Glad you are having a good day, but let's not classify a 7% gain or even a 15-20% day gain as an "epic run". If this surges past 2.00 today (which I don't expect to happen again until more significant and positive test result news), then you could say it had an epic run of sorts.
Meanwhile, the market is up on good news and carrying a lot of stocks with it. Hopefully the pull back to 1.20 set a ST bottom and we climb back over 1.50 next week.
When all is said and done, it's a good LT bet/play. Can't invest ST guessing at when/what will be announced and all those that claim manipulation when a stock retreats after a rapid launch are searching for excuses/reasons that don't have a basis.
I was hoping that the history of a longer term trading base between 1.30-1.40 would hold after the launch, but was prepared for a pull back of greater length.
This could still test 1.00 over the upcoming weeks without any news or it could gradually climb from today's dip.
We just don't know, but we are in a pretty good risk/reward area right now and I'm relaxing for LT gains, LT being within the next year, but not the next week.
GLTA
Leave it there for tomorrow and I expect it will be filled. Company has stated on CC that the trials for primary drug candidate mentioned as having potential for lung cancer treatment is expected to go into 2020 for dosage alone, so while I'm hoping to get shares for LT at better price and recoup minor losses, there is nothing in the conference call to sustain a 60%-100% increase in price or valuation based on a new potential application of the drug that would have to gather more data before entering clinical trial stage.
What the CC reaffirmed is that the company seems to be cooking with gas and is making real progress on variable fronts and the data thus far is more than positive without any negative events.
Since the stock wasn't climbing and is expanding trials and expenses, I'm hoping to get more shares nearer to $1.00 than $2.00.
Those hoping for $3.00 can close their books. No BIG news. Call just ended and this will go where those who don't want to hold will send it.
In spite of $22M in cash, which they expect will last until data comes out later this year, more cash will be needed. The 1.60 9.3M sales was an opportunity that presented itself and I think they did an excellent job in capitalizing on it, but this won't rocket anywhere but down tomorrow, if it goes anywhere since there is no new news to speak of.
Put all the PRs together and company has gone from 1 clinical trial to 4 and potential 5th later this year.
The most significant factor stated in CC is that they expect to report trial data every Qtr going forward because of the various trials ongoing right now. However, note that CEO also stated, the faster the trials go in enrollment, the greater the spend in their R&D and the sooner they will need more capital. The good news from that is that he projects good trial data will bring in more discussions of potential partners, but there is no golden egg about to be laid.
This is an excellent LT play based on what was said in CC and there will be ST plays on trial data news, but I don't see this going anywhere near $3.00 in the ST.
All is opinion based on the expectations around this CC and what was said on the call, to which I listened.
Except institutional sales aren't done on hype or via a PR. Before institutional investors agree for large purchases, there would be more data exchanged.
The Vanguard Group owns the most shares and besides outright shares, there are 5 different Vanguard Mutual Funds that own MBRX.
My broker shows 29.1M OS, which most likely doesn't include the 9M+ being issued currently.
Good news I see is this month alone MBRX has new 20M+ in cash and while the earlier offering price was $1.00, the second was 1.60 and 1.75. I've been in development bio that sold shares for pennies to raise funds. Here MBRX was able to raise their share price 60% in less than a month and sell more shares at the higher price to raise cash.
I take that as a very good sign LT as to what their data is showing.
It's Koos' way of paying himself multiple times with both salary from companies that don't have money and then loaning money back to those companies for shares.
It's a way to pay himself at the rate of CEO multiple times for what otherwise would be various depts of the same company. When he maxes out shares, he founds another company and then either hires himself or pays himself a salary as president.
The wait is over. Have to say I'm pleasantly pleased that the deal is with a name brand company and not some smaller start up. This should grind upward over the coming months and now news on over pipeline products with get more attention with a possible partnership with Novartis is looming behind every new product.
Looking for significant gains over the coming months.
Good morning. Haven't been following day to day for a while. After the 1:500 RS, how many shares currently outstanding?
Here's a shareholder proposal for the next meeting:
We hereby propose that all paid administrators and staff salaries be frozen at this time until the share price rises over .50 PS. Furthermore, administrator and staff salaries shall be paid 50% in cash/check and 50% in common shares of Delcath. The number of shares given each pay period shall be fixed on the first pay period of the year with the number of shares being calculated based on the average closing price of Delcath in the prior year.
In this way, the PPS goes down, we all suffer together as their salary equivalent goes down during the year if the PPS goes down etc. They don't get extra shares as the price drops. On the other hand since they get fixed number of shares each pay period, their salary equivalent value goes up if the PPS goes up.
I bet we would see decisions made differently. As it is, they don't hold any stock in the company (very little) and so don't care about PPS. All they care about at this point in my opinion is getting $20M to get through 2018 and it doesn't matter how many shares they have to issue to get it. They will RS and keep ceiling at 1B shares so they can do it as much as they need. They aren't going to be able to do any deals for .02 or above at this point unless they RS. And the way they negotiate, if they give 50% of share price for $5M raise deal, they need to do it 4 more times.
Once the $20M is raised, I'll buy back in. Until then, PPS is no concern of theirs as their salary is not tied to performance in any way and they aren't investing in company shares themselves.
I will.
The situation is bad any way you look at it.
If DCTH has some unannounced plan with ANTX to build the company up, or merge or partner, then keeping that under wraps while diluting and announcing more dilution without such news is knowingly driving the PPS down for current stockholders unnecessarily.
If there is no secret LT plan as some suppose, then they are being brutily straightforward with a plan of needing to raise another $20million dollars for 2018 alone and we are already at .02. If they were able to get .02 for every share sold to get to $20M, that's a billion more shares to be sold from current or remarkably near Sam's 1.5 billion shares to get through clinical trials, with exception that it only gets us through 2018 and so might need even more.
What bothered me the most in filings is that they specifically state that not only do they want to increase OS to 1B, but they want it to remain at 1B even when they activate another RS at 1:100 - 1:500 shares. I.E. they plan on raising all capital from dilution selling and are not anticipating the PPS going up. They need to keep selling and RS with OS capped at 1B.
With that as stated goal, how is the current value of PPS going to hold?
I don't understand how this filing on the heels of selling around 250M shares at .02 can make anyone happy, but that's what they have filed and gone public with. If they have some other grandiose plan/agreement with ANTX, why would they keep that a secret. Wouldn't they issue PR once patents were free and clear that they were in negotiations with another company to a) for possible merger in order to finance trials b) negotiating with a company for partnership etc which would boost PPS and make new investors happy who bought at .02 and draw more investors at possibly higher price.
Instead, on the heels of striking a deal for potentially about 750M total shares at .02, they announce further share dilution to the tune of raising 20M more than the 5M they raised guaranteeing 750M total share purchase at .02.
Strategy wise, I can't make sense out of any of it and so I sold today. Second time around I've lost big. Who would have thought that .03-.04/share for a company with phase 3 trials was overpriced.
I'll buy back in if I see insiders start to use some of their $500K salaries to invest in the company. Until then, buyers beware I guess
We don't count. They made a deal for which they don't have the shares and .02 is the going rate in their done deal agreement. Not much hope for any upside at this point as those buying or cashing in warrants at .02 will be selling as soon as they can before the RS and probably swing another debt deal once the price falls back.
Here I thought we had waded through the worst over the past 2 months, but there is more of the same ahead.
Sad. Why couldn't they wait and put out some good news, letting the price recuperate a little.
No wonder no insiders are buying any shares. We own more than they do, but they've got their salaries, so they don't care about PPS or owning the stock.
Disappointment is the misleading filing where they seemed to indicate .04 share to raise 10M and a short time later close the deal at 50% below that and only raise half of what the original proposal stated as the amount to raise.
That's pretty deceptive or desperate. Certainly, they knew who they were making the deal with and getting half of what they filed for is extremely disappointing.
Very encouraging day with price action and increased volume.
Obviously, the registration taking "Effect" yesterday is seen as a good sign by some.
We are up against technical resistance on chart posted above on this msg board, which I see as reason for slowing down price action climb.
The company's "silence" regarding press releases, but methodical steps of getting through debt structure and moving directly into new financing seems to be sign of a truly agreed upon plan of action decided upon previously by company and being put into action.
I would have to believe that vision is one that didn't and doesn't expect the PPS to drop after RS from 11 to .03 and remain there, so I am feeling very good about where we could be not only LT, but in the near future (1-4 weeks).
Glad I came across this board and DCTH once again. I had owned it years ago and lost plenty when initial trial data was rejected. Hope I can regain part of that with entry at these levels.
I expect company PR with next 7-10 days.
Expecting that the worst is over with 8K release today. I had expected potentially a few more days to clear the Notes, but obviously, the agreement and expectation was to clear out all those shares asap. Therefore, even with the up to 250M more shares to be sold, the pressure of the note holders selling what they got is over. We may not sell the entire amount of securities offered pursuant to this prospectus. There is no minimum amount of proceeds that is a condition to closing of this offering.
And those buying new shares or warrants from the new registration are only institutional investors who I wouldn't expect to be buying them to turn around and sell immediately, so the methodical selling we've seen recently would seem to be over for a period of time.
This offering is being made in the United States only to investors which qualify as “institutional investors” under the state securities laws and regulations of their state of domicile. The public offering prices set forth on the cover page of this prospectus have been determined based upon arm’s-length negotiations between the purchasers and us
Has been very interesting few weeks with first, the weekly 8K telling us about OS shares, then the 8K about the satisfying of noteholders, followed by the surprise announcement of new shares and warrants all packed into a tight window. Finish that with today's 8K telling us immediately when debt and IP has been cleared and it seems to me this is all leading up to something very significant over the next month. News that may quickly reverse the PPS.
For now, the only selling pressure will be from those buying in .02s and .03s who want to flip for % profits. As those get cleared out, as many did with today's quick 7M purchases in 30min, I am very optimistic we continue to move up.
In fact, the line stating that the price per share has been determined based on negotiations between purchasers and DCTH to me mean they already have people lined up for a significant portion of those new shares which to me means the .03-.04 range is going to be a very strong base with no additional selling pressure from the newly released shares.
When you look at the price chart summary and that after RS(s), the 2015 PPS was the equivalent of over $8,000/shares (sorry for those guys) and in two years we are at .03 PPS, but now with no debt, no liens and cash on hand with 3rd Phase trial going well, this is best opportunity to buy if DCTH ends up succeeding.
While MAXM might not have been a lead seller, he was still there, parked at .0318 for quite some time and below .03 at one point. Couple of others flashed 1M+ sells in last hour of trading as well.
I don't think the selling is over but with most likely over 200M shares OS at this point, the investor shares are most likely nearing their 9.99% and 4.99% thresholds. Whether they sell all the shares off or only until they don't qualify for more shares is anyone's guess.
Problem is, we aren't at 200M in reality since DCTH announced another 250 million (basically almost maxing out their approved 500M OS) before the 223M total on investor buyout was completed. Why did they announce the additional 250M so soon unless it is part of a short term plan?
But anyways, any valuation calulations should be on 473M OS shares already announced, not 200M.
Possibly the first day of trading without the "Leak-out" restrictions. Without the announcement of the additional 250M shares to be released, I would otherwise be hopeful the investor deal shares would be possibly coming to a close this week with larger volume.
What the impact of the further 250M dilution is going to cause is anyone guess as to who is interested in buying those shares.
Not anticipating any imminent run at this point, but hope to buy back around .02
Pretty amazing that this board is so abandoned.
Also amazing that a company after working so long to get approval, can't make a deal or accept a deal after 7 months.
Still, lots of people exchanging options on this. I still have hope.
Ditto on questioning why people think this is going up soon.
However, I am struggling to understand why you think price will move up on the latest news. Especially the idea that "price will move pretty fast from here, above .10 easy and .25 by end of month."