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Well, there you have it folks:
If DECN does NOT produce data = "see, they are a scam"
AND
If DECN DOES produce data = "see, they are a scam"
A decision has already been made.
DECN - The Diagnostic Testing World's Black Swan Event?
Let's say the FDA had not heard of E.I.S. (electrochemical impedance spectroscopy) as a biological testing option before KB submited his application, which induced a storm of conversation between the company and the FDA. What of E.I.S.?
It is widely used in blood glucose testing.
Turns out there are courses taught on the subject, and at least one mainstream book publisher has a textbook on it:
https://www.wiley.com/en-us/Electrochemical+Impedance+Spectroscopy%2C+2nd+Edition-p-9781118527399
Other recommendations include:
https://www.researchgate.net/post/Please_recommend_a_book_on_impedance
A Pennsylvania company specializes in E.I.S. instrumentation. https://www.gamry.com/application-notes/EIS/
Interestingly, KB identified Pennsylvania as the location where some testing might be done: "We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week." (4/23) At least I'm assuming "make use of" is somewhat equivalent to "conduct a donor study" - who knows . . . maybe he has solicited Gamry to help with final design and tweaking of the instrument????
It is a given that technology moves rather quickly and can sometimes move exponentially . . . and those not willing to accept it may end up like Einstein in his apology to Lemaitre. Things just can't work that way . . . until they do.
"Proposals can use any technology to detect an active infection and will be evaluated for their likely success in improving testing performance—qualities such as speed, reliability, and accuracy—and ease of use, such as detecting the virus in saliva or exhaled breath."
This is pretty much what I heard from the FDA today. They are not discounting any method that can be validated.
https://www.sciencemag.org/news/2020/04/nih-launches-competition-speed-covid-19-diagnostics
I just hope he concentrates on getting the testing done asap and getting the results to the FDA so the EUA can be finalized and production can begin by summer for GenViro! Swift (PRO). With the NIH, CDC, WHO, and our media indicating the crisis will last quite a bit longer, the role of serology confirmation and the new "novel" approach (E.I.S.) submitted by Decision Diagnostics will be important to helping keep the country open. I don't know if we will hear from him about this during the suspension, but the validation testing should be ongoing soon, and hopefully he will release a PR about that when it is completed. The future of Decision Diagnostics hangs on a test that he claims was validated in Daegu, SK for H1N1 and coronavirus (but not SARS-2 specifically). Now we validate it for SARS-2 in the U.S., and, well, we wait for "whatever's next."
$DECN
Berman played the system like a pro. He followed the FDA's guidance and will soon be selling the kits that some think are phantasms. They should not have overlooked his PRs. His PRs tell the entire saga of an over-exuberant CEO describing an exciting venture to his readers. It is all there . . . not easy to decode, I will grant, but there nonetheless.
Since there is a pre-EUA, the FDA has chosen, in this case after discussion, to let the request move forward, fully aware of the content. We await validation.
$DECN.2
It is coming.
Very much so
Search the document title
(Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency)
Based on the guidance from the FDA if the test is serology-based, Berman can start selling the kit as soon as it is validated (within 10 days from 4/23 + 7) and manufactured. He is required only to follow certain labeling guidelines and post certain information on the website about the validation.
If the test is not serology-based, the EUA and 15 day window apply, and if, in the EUA review process, the FDA finds a problem that cannot be addressed via an amendment to the posted/printed material "and the manufacturer has already distributed the device, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test."
He is probably going the EUA route at the advice of the FDA (because the test was determined to be other than serology-based).
Of course it references the Pro kit. On 3/16 he clearly states the home test kits will come later. In 4/23 he formally introduces the "at home" kits.
Naw, he didn't just "mean" to say it, he said it!
See 3/16 PR subheading
Keep read'em
Naw, check'em . . . !
3/16 Wholesale = $6.95
Where does Berman say the retail kit will be priced at $6.95?
As early as 3/16 he says $6.95 for wholesale.
PumperStumper
What are we denying?
What proof do you have of any wrong-doing bt DECN?
Assuming he has the pre-EUA authorization letter . . .
Any reason why KB could not post the pre-EUA authorization letter to offer some confirmation?
Hey, KB . . . !
$DECN information
If you are long DECN, here's what you can be doing
because it is all that really matters at the end of the day.
Berman's PRs say (and thousands of investors clearly believed them) that an EUA application was submitted and the company has the pre-EUA acknowledgement letter (PEUA200232) and now has received feedback from them regarding testing protocols, which are being implemented within the next 10-20 days.
SO
Attempt to verify the existence of a pre-EUA for Decision Diagnostics. Why? If there is a test kit built and verified in S.Korea AND it has made it this far (FDA counsel retained by management on 3/11 and EUA filed on 4/6), the situation is much brighter.
Remember, honey attracts more flies than vinegar.
Sources: FDA (Center for Devices and Radiological Health)
https://www.fda.gov/Medical-Devices
COVID19DX@fda.hhs.gov
Customer Service: 1 (888) 463-6332
Narrative Interpretation - Reading PRs in Context
3/3
“Keith Berman, CEO of DECN commented, "We have the technology perfected which will take months off of the development schedule.”
The language is clear: there IS a development schedule, which is shortened by the availability of work completed previously. They do not have to re-invent the wheel to get started on the COVID test. Berman does not say, nor does he imply here, that the COVID test is at this point "perfected."
3/4
“What makes the testing for the Coronavirus possible, and the GenUltimate TBG special, is the company's Impedance measurement technology.”
This is made clear in the next citation below.
3/11
“Keith Berman, CEO of DECN commented, "Because we perfected the Impedance technology in 2019 for our GenUltimate TBG glucose test strip and meter, we have shaved months off of the development time for the GenViro! device.”
I'm not sure how much clearer the logic could be. If you take any one PR as a stand alone, you clearly failed to read the first PR, which should have been a clue: "Today, in a breakthrough discussed for the first time, DECN announces in this first of three releases, expected in the next 10 days, the introduction of our new screening methodology for the Coronavirs (Covid 19)."
Isn't that interesting . . .
If the SEC read through all the PRs
and interpreted them in context, I think they could see that he meant by "perfected techology" the technology they were using in the diabetes testing. I think twice he mentions 2019 as the year in which they perfected it, which could not have been a reference to COVID - he followed by indicating the "perfection" would "save months of development time," which clearly suggests that some development was still needed. The FDA clearly understood this as his counsel began conversing with them on 3/11.
In true Berman style, I'll have an update tomorrow.
(Ran out of whiskey!)
So, I've spent the better part of the past 6 hours re-analyzing the PRs from 3/3 to 4/27 and building a timeline of references and tracking the development of the test kit and submission to FDA for EUA. I will try to find a way to submit what I have put together for your consideration; however, I will say that if you know the new FDA guidance for EUA submissions for diagnostics, Berman is pretty much right on track. Two things became very apparent, one of which I plan to email him about tomorrow: 1) he needs to take a course in Organizational Writing or at least let someone read the PRs before he submits them, and 2) he clearly knows what he is doing and is doing it correctly - regarding the submission (whether or not the FDA will grant the EUA authorization is THE question).
In light of current SEC actions
consider ourselves lucky that this CEO has not been making claims of any kind about what the drug may or may not be able to do in relation to any component of COVID-1 on this plane or in any other universe that may or may not exist, whether really, relatively, or quantumly.
Indeed!
Let's keep the language straight:
Regarding the first test, DECN will either get:
1. A "conditional approval" for the Pro Test kit
OR
2. An EUA authorization (not approval) for the Pro Test kit
I believe, depending on what happens with the first kit, Bermans will follow the same track for the second (At Home) kit.
No, but I was not looking for that.
I was looking for process information, and what I got in response seems to be encouraging. First, in conversation with the FDA, I was told that basically for a product to get a pre-EUA authorization, it must have the possibility of succeeding, i.e. there must be something there. You cannot fake a pre-EUA number. The pre-EUA is not simply an "okay, lets get started - what do you have?" application.
It requires data as indicated by part of the response I got from the CDRH: "A pre-EUA (EUA) is generally the initial data and testing plans. We work interactively with the submitter. We do not review submissions prior to accepting (e.g PEUA). We assign number and reviewer and work from there. A PEUA does not guarantee an EUA authorization." Of course, we know the last statement to be true. No data, no plans, no pre-EUA.
Berman's language in the PRs (I reread them carefully today) shows a very clear path of development (even if his language is not always clear). The bottom line for the first pre-EUA submitted (The GenViro Pro model - only for professional use) is the request for "conditional approval" which will replace the EUA process. He stated on 4/23 that they had built the kits for testing (4/7) and had engaged a specialty reference lab to do testing, which was to start within ten days from 4/23 and be completed within one week. Therefore, the pre-EUA process for the Pro kit will not (likely) be completed before the suspension is lifted. However, the "conditional approval" may be granted before.
If No GenViro Device - No pre-EUA:
"A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency situation."
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda
Pre-EUA processing is being done at:
Center for Devices and Radiological Health
Contact info: COVID19DX@fda.hhs.gov
Site: https://www.fda.gov/Medical-Devices
Better Get It Right the First Time ... Or Else!
https://finance.yahoo.com/news/praxsyn-retracts-prior-press-releases-232028733.html