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plutoniumimplosion, then PROVE your friend didn't deceive people.
--- You were also tricked until I told you specifically.
Did you find the Acknowledgement Letter???
jimbob4, Why?? The truth hurts, doesn't it??
--- If CEO Berman stop deceiving people via PRs and interviews, then I will stop.
I have the right to balame falsehoods since this is a public forum.
I do remember you publicly lied to raise money. PROOF??
1. You used to say that DECN submitted the FDA-mandated testing results to the FDA, which is completely false.
2. You said that an EUA is imminent, which is totally wrong.
3. There are more, but I don't want to read your old posts.
plutoniumimplosion, To Deceive people and Hype about non-existent test kits (SEC filing),
Berman published the repeated, phoney press releases.
Proof??? --- You read the PRs from March. --- In the post I wrote today, I quoted some sentences that were fake and contradictory.
ALL this was only aimed at rsising the DECN's stock prices.
DECN should have disappeared from the stock market already because of the stock manipulation via fraudulent PRs and interviews.
For some reason, Raffis had said the right words in July.
Postings by Raffis on July 23 & 24 :
--- Berman clearly lied in ALL Press Releases .
--- There is NO functionally proven GenViro.
--- Berman completely contradicts himself.
--- Berman already risked "jail time, fines and lawsuits."
--- Today's press release describes NO accomplishments.
--- Berman didn't do anything that he published.
sroks5, There are many videos of the COVID-19 test kits that obtained an EUA.
Those companies tell you the accuracy of sensitivity and specificity on thier websites.
Some companies did NOT make a video of their kits even though they obtaied an EUA.
--- FDA does NOT request a company to make a video of its COVID-19 test kit.
A video of DECN test kits means nothing like one of the meaningless and useless YouTube videos .
Most importantly, ALL COMPANIES that received an EUA publicly announced their clinical results of
the accuracy of sensitivity and specificityBEFORE they submitted the results to the FDA.
DECN makes a video its test kits just to release a PR and raise the stock price.
--- DECN's video is not that significant because that is just a video of crappy test kits
that cannot detect positive from infected samples ( i.e. very poor sensitivity) for 5 months. --- If I am wrong, tell me the accuracy of sensitivity of DECN test kits. You tell me.
To publish a PR and raise money, DECN makes a video of its test kits.
--- IF NOT, who on the earth makes a video of crappy test kits.
Raffis, You had said the right words.
Do you mean the repeated , DECEITFUL news???
Postings by Raffis on July 23 & 24 :
--- Berman clearly lied in ALL Press Releases. Only empty lies.
--- There is NO functionally PROVEN GenViro.
--- Berman completely contradicts himself.
--- Berman already risked "jail time, fines and lawsuits."
--- Today's press release describes NO accomplishments.
--- Berman didn't do anything that he published.
Raffis, Stop talking nonsense and start saying all the right words again.
timetravelerdos, Real COVID-19 stock???
Like I told you, I hope you make lots of money.
However, how can you say this is a real COVID-19 stock even if this Pink stock price (0.04?) makes you very happy??
1. CEO Berman is a crook. Proof?? --- Read the PRs full of repeated lies and contradictions since March, dragging his feet only to make quickly and easily without thorough research and efforts.
2. DECN COVID-19 test kits are crappy.
Why??? --- DECN test kits have never proved 90% sensitivity during March, April, May, June, July, August, and apparently forever due to the stupid technology of DECN COVID-19 test kits that competent researchers have ignored.
Real COVID-19 test kits usually receive the CE-IVD and an EUA from the FDA within 4 months at the latest. --- This means that first, a real COVID-19 test kit is tested in a reliable reserch institute and then the FDA-mandated clinical trials are completed and get a CE mark and the FDA EUA for four months.
Crappy DECN COVID-19 test kits released fake news for 5 months (March, April, May, June, July) in order to raise stock price and volume, stalling for time.
Crappy DECN test kits have never been properly tested in any lab or institution in Korea or the States since March. However Berman has been deceiving people for 5 months, saying that DECN test kits have the accuracy of 98% without telling the accuracy of sensitivity via PRs and interviews.
It is August now. --- DECN submitted EUA Applications without any results of clinical trials, so FDA still can't accept the applications because DECN couldn't submit any testing results.
--- Even if DECN received the results of sensitivity and specificity from Korea sometime in September, I assure you that DECN can't submit the very poor and embarrassing sensitivity result to both the EU for a CE mark and the FDA. --- (I already explained the reasons in this posting, so do not ask me why.)
Look at the DECN volume &
Here is the answer for you:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157348504
(Correction) : It is reported that if DECN's Partner in Korea makes DECN test kits for export to other countries such as Brazil, Thailand, etc., then the manufacturer's test kits must be subjected to rigorous clinical trials with much more infected samples in Korea than the U.S. for the accuracy of sensitivity .
S6DECN DECN = CE mark ??? Technically, CE-IVD
sroks5, The stock price of DECN is only about 0.4.
The stock price has soared from the first fraudulent PR on March 3, 2020.
The stocka was almost dead Until March 2, 2020:
Price -- 0.018?
Volume -- less than 1,000
DECN had been suffering from a huge deficit.
--- The con artist, CEO Berman has released so many PRs full of lies and contradictions
in order to raise the stock price, cheating people.
The SEC suspend DECN based on only news releases up to April , not May, June and July.
We are telling the truth based on the PRs that CEO Berman stated.
Raffis, Today's PR means absolutely nothing. --- It will take more than a month to get the accuracy of sensitive from the people infected with COVID-19 in Korea.
According to the news in July, DECN would soon decide which laboratory in the U.S.
would conduct the FDA-mandated clinical trials for the DECN test kits.
Berman's top priority is to find the institute in order to complete FDA-mandated
performance testing in the United States and submit the results.
Do you think Berman submitted the result of sensitivity to FDA when DECN turned in the EUA Apllications in June or July?? --- Still under FDA review.
FDA grants a company "approval" for an EUA Application if evaluation data involving company's initial testing results. were well validated.
Bottom line: FDA has NOT granted DECN "approval for the EUA Applications
for more than a month?? -- So NO LAB to test.
I wonder when DECN/Manufacturer submitted EUA applications to FDA in June or July.
Raffis, the Acknowledgement Letter does not gurantee an EUA, but it implies a very important thing.
Shouldn't DECN at least try to receive the Acknowledgement Letter with a "submission number" in order to release lots of meaningless news and raise the stock price??
--- There's no chance for DECN to get the letter, though.
First of all, I haven't mentioned the price, 0.06.
I do not visit the ihub every day, so I don't read many posts.
What's most important is that there are a number of rationable people
who can judge right and wrong.
There are so many fraudulent DECN PRs full of contradictions and lies since March 3.
--- Thus, DECN was suspended by the SEC : Yes, DECN = SCAM
I do hope you make a lot of money but stop defending this fraudulent stock
that is only 0.4.
At least conscientious DECN shareholders keep their mouths shut because
they will be ashamed to make money by publicly defending this scam & CEO Berman.
In other words, they are far better than a few on this board who are
thick-skinned with no scruples like CEO Berman.
Raffis, don't compare NASDAQ:CODX and fraudulent DECN.
Leading newspapers reported 100% sensitivity of the COVID-19 test made by
Clinical Reference Laboratory (CRL) in June -- if my memory serves right.
Reputable companies do submit EUA Applications along with the
results of their own testing.
--- Those companies are proud of thier COVID-19 tests, and the testing results
are publicly reported in advance before they submit the testing results to FDA.
Their FDA-mandated testing results are usually similar to their own testing results.
plutoniumimplosion, where is the Acknowledgement Letter that FDA sent to DECN???
DECN submitted only a Pre-EUA application on April 4 and got the Pre-EUA number (PE200232), on April 4 but not (EUA200232).
--- EUA number is important, but not Pre-EUA number.
DECN CEO Berman did brag about it via news releases on April 6 and 7 saying that
DECN received the Pre-EUA number.
---I wonder when DECN submitted EUA applications.
DECN news on July 10 says that EUA applications are still under FDA review.
So Berman has blamed the FDA???
--- Blame the DECN test kits that can't detect positive ( i.e. infected people)
with 90% sensitivity.
Ah, some are really blinded by money like CEO Berman whose hobby is to cheat people
in order to make money. ---Proof?? Read the contradictory news releases published by Berman March since March.
--- Berman is a swindler that published two news releases about Pre-EUA number
to hpye and make money: two PRs on April 6 and 7.
--- The Pre-EUA number is automatically granted to any companies that handed in a Pre-EUA application.
DECN submitted the EUA applications a month ago, but
still couldn't get any submission number from FDA.
--- Do you understand what this means???
Some on this board are skilled in deception. --- Shame on you!
DECN CEO Berman = A Crook that is cheered by some people
who seek only money of greed.
Raffis, I thought "UCCE" is a company like fraudulent DECN.
Raffis, that's ridiculous news which means nothing.
Ah, the fraudulent company!!!!!!!
(edit) plutoniumimplosion, where is the Acknowledgement Letter from the FDA???
Did Berman lie to you?
Do you know how many times Berman has cheated the shareholders?
Isn't it true that Raffis gave the idea of the saliva test to Berman??
(edit) plutoniumimplosion, are you saying that Berman lied to the shareholders???
Berman stated (April PR) and mentioned (in May) that DECN would complete the FDA-mandated testing.
Raffis, CODX (NASDAQ): The test is the PCR test (i.e. molecular test)
Didn't you say that you gave the saliva test idea to CEO Berman???
--- Does DECN have the RT- PCR technology???
--- Does DECN have the RT- PCR technology???
--- Does DECN have the RT- PCR technology? --- Since when???
Dream on!!!
jimbob4 & DECN shareholders, News on July 30 :
Johns Hopkins University had conducted performance testing of the DNALINK FIND COVID-19 antibody test.
DNALINK FIND COVID-19 antibody test proved 95% sensitivity and 100% specificity.
DNA LINK, Inc. will submit the performance evaluation report to the FDA.
To obtain the FDA's Emergency Use Authorization (EUA), DNA LINK, Inc.
had requested Johns Hopkins University to conduct the performance testing.
FYI, DNA LINK, Inc. is not listed on the U.S. stock exchange.
plutoniumimplosion, your friend, CEO Berman is very fraudulent and a recognized liar.
Why?? --- DECN cannot receive the "Acknowledgement Letter" from the FDA.
PROCEDURE
1. Submit a Pre-EUA Application.
--- DECN only submitted the Pre-EUA Application to the FDA.
That is why DECN only received the Pre-EUA number (i.e. PE200232), which is
ALL applicants are automatically granted.
(You can't find the Acknowledgement Letter because the FDA didn't send it to DECN.)
2. Submit some additional data required by FDA within 2 weeks.
3. Submit FDA-mandated Testing results.
Common sense is that if the testing results fall short of the FDA criteria,
companies will give up submitting the results.
4. If FDA thinks the testing results meet the FDA criteria, then the National Cancer Institute (NCI) will conduct the COVID-19 test again for the objective performance evaluation of the test.
5. FDA issues an EUA Registration Number to a company.
6. If the COVID-19 test proves to be (over) 90% sensitivity conducted by the NCI, then
FDA issues an EUA to the company.
To sum up:
1. DECN submitted the Pre-EUA Application to FDA on Saturday April 4
and automatically received Pre-EUA number on the same day -- PE200232.
--- Plexense, Inc. submitted the Pre-EUA Application in mid-May.
2. Companies submitted additional data within 2 weeks of application.
--- Plexense submitted materials and all the results of their own clinical trials.
3. After Plexense submitted all the FDA-mandated testing results,
FDA sent Plexense the Acknowledgement Letter on June 29.
--- DECN haven't submitted the FDA-mandated testing results.
Thus, of course, No Acknowledgement Letter to DECN.
4. On July 2 , FDA issued an EUA registration number to Plexense by email.
The EUA registration number is the same as the submission number (EUA201904).
--- Once a company receives an EUA registration number from FDA, the company can sell its COVID-19 test.
5. Plexense, Inc. is waiting for an EUA from the FDA.
In mid-May: Submission of the Pre- EUA Application
On June 26: Submission of EUA application along with the Testing results
On June 29: Received the Acknowledgement Letter with "submission number. "
On July 2: Received the EUA Registration Number which allows
Plexense to sell its COVID-19 test from July 2.
Plutoniumimplosion, do you understand what I'm talking about???
You can't find the "Acknowledgement Letter" because DECN haven't handed in the
EUA Application along with Testing results.
So FDA doesn't not have to send it to DECN.
Besides, think about this. IF the DECN test kit had proved 90% sensitivity,
Berman would have let the world know every other day via news releases and interviews
to raise the stock price & volume.
--- DECN test kits were unable to identify positive for COVID-19 with 90% sensitivity during March, April, May, June and July.
Can you suddenly turn that DECN kit into a well-functioning kit with 90% sensitivity in August???
I can assure you that DECN cannot get an EUA even if you wait.
(Question): Why DECN shareholders have to wait until September???
As soon as the FDA-mandated testing is over, if CEO Berman doesn't let you know the accuracy of sensitivity of DECN test kit, that will be the clearest proof that DECN can't get an EUA.
Y(edit) Raffis, No CE mark because of the accuracy of sensitivity.
"Sensitivity" is the ability to define positive for COVID-19.
You and CEO Berman are alike in many ways.
Berman did say that DECN will try? to obtain the CE mark in a March news release.
What has Berman done so far in March, April, May, June, July???
You said you offered Berman the saliva test, didn't you??
jimbob4, DECN will get neither the CE mark nor an EUA:
1. It is certain that DECN did its own first or second clinical trials.
--- PRs & Shareholders were told that 98% accuracy.
(i.e. 98% specificity, but not sensitivity)
2. Anyway, let's say DECN submitted all the required documents to FDA.
3. DECN has to find an "external clinical institution" for FDA-mandated testing.
4. Even if testing results of the accuracy of sensitivity & specificity conducted
by the #3 laboratory were excellent, all COVID-19 tests must be tested again
by the National Cancer Institute (NCI) for the objective performance evaluation.
FYI, Access Bio, Inc. is registered in New Jersey, and produces products there, but
the company is not listed on the U.S. stock exchange.
July 7: Access Bio, Inc. got an EUA for CareStart COVID-19 RT-PCR.
July 24: Access Bio, Inc. got an EUA for CareStart COVID-19 lgM/lgG.
(The Access Bio antibody test kit had 100% sensitivity & 98.4% sensitivity respectively
in both FDA-mandated testing. -- Of course, it has superb specificity.
Berman has lied and boasted about all sorts of things except for the accuracy of sensitivity.
He does know the accuracy of sensitivity & specificity via the test kits' clinical testing.
That is why he told shareholders the accuracy of specificity: 98%
--- Why has Berman never mentioned the accuracy of sensitivity
for more than 4 months???
FDA issues an EUA to any kits that prove 90% sensitivity.
--- 90% sensitivity is the key to obtaining an EUA.
DECN can't get an EUA because of 90% sensitivity.
Berman is just dragging his feet.
I hope you make a lot of money, but do not spread misinformation.
Proof? --- You used to say that DECN submitted the FDA-mandated testing results to FDA.
A link, please.
plutoniumimplosion, PE200232 = DECN serial number
April 7 PR: DECN received the Pre-EUA Acknowledgement and device serial number on Saturday, April 4, 2020.
Have you ever seen the Acknowledgement Letter that DECN received from FDA???
jimbob4, PE200232 = Pre-EUA DECN serial number -- (April 6 PR)
Have you ever seen the Acknowledgement Letter that DECN received from FDA???
The following is the Acknowledgement Letter that Plexense, Inc. received from FDA
on Monday June 29, 2020.
6/29/2020
Barbara S. Fant, PhD, President
Clinical Research Consultants, Inc.
3308 Jefferson Avenue, Upper Level
Cincinnati, OH 45220
UNITED STATES
Dear Barbara S. Fant, PhD:
The Center Decices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has received your submission. This submission has been assigned the unique document control number below. ~ ~ ~ ~ ~
Submission Number: EUA201904
Received: 6/26/2020
Applicant: Plexense, Inc.
Device: ACCEL ELISA COVID-19
We will notify you when the review of this document has been completed or if any additional information is required. If you are submitting new information about a submission for which we have already made a final decision, please note that your submission will not be re-opened. blah blah blah ~ ~ ~ ~ ~
Sincerely yours,
Center for Devices and Radiological Health
jimbob4, DECN must have completed the first clinical testing according to the PRs.
That is why Berman has mentioned the accuracy of specificity which is over 95%
-- (You read the PR yourself) but he has never mentioned the accuracy of sensitivity.
FDA does not issue an EUA to any test kits that do not have 90% sensitivity.
CEO Berman = NEWS RELEASES = SCAM = DECN TEST KITS = NO EUA
How poor the volume is!!!
(edit) That's one of the reasons I say CEO Berman is a fraud.
Ah, a few traders and cheerleaders who still stand up for the crook .....
Why can't they differentiate the truth from falsehood??
I don't think there's a problem with the left hemisphere of their brains.
CEO Berman mentioned twice that FDA-mandated Testing would be completed
by mid-May.
To raise stock prices, Berman said that in April and May.
CEO Keith Berman is a recognized crook full of lies and hypocrisy
except for his breathing.
Berman, you would be the first and last person in my life who
made me use the most harsh and worst words.
Raffis, you're mad, right??
I wonder when you'll change your mind again.
Raffis, you can't underestimate Berman.
You were once enthusiastic about his hobby:
To make money while stalling for time, how many PRs has Berman published so far
after publicly mentioning that the FDA-mandated testing would be completed
by mid-May???
Who made such defective, crappy test kits for COVID-19 that can't get an EUA
and could harm people's lives??
And then Berman blames the FDA???
CEO Keith Berman - Swindler who sold his soul for money
Berman, I think you read "every post" every single day.
I wonder when you are in your right mind.
You have such a good friend. --- Your friend will show up.
Johnny C, EUROIMMUN SARS-COV-2 ELISA has sensitivity 90% but received an EUA.
DECN test kits have specificity 95% ~98% but have no sensitivity 90%.
As a result, NO EUA to DECN test kits forever.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance
Raffis, listen carefully. The FDA does issue an EUA to a test kit which has
sensitivity 90% & specificity 95%.
DECN tests have never had sensitivity 90% for four months.
-- Not eligible for an EUA forever.
That's why Berman can't tell shareholders about the accuracy of sensitivity of DECN kits.
He informed people of the accuracy of specificity, though -- 95% & 98%
I have told you many times that DECN test kits can't get an EUA forever because of
sensitivity 90%, not specificity 95%.
CEO Berman has been deceiving people since March as if DECN were about to get an EUA.
Berman = Scam = DECN test kits = No EUA