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According to DECN CEO Berman,
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157958688
I already mentioned the "new FDA guidelines in my previous post.
Until today, No labs in both Korea and the US to test only 30 to 40 infected / positive samples
If a U.S. laboratory tests 40 positive / infected samples with DECN Saliva test kits, you will see what the sensitivity percentage the DECN saliva test kits have. BUT???
DECN CEO Berman has been publicly deceiving people about the COVID-19 test kits since March.
CEO Berman first mentioned the saliva test kits for professional and at-home use on July 10.
(big sigh) plutoniumimplosion, I already did provide it in my post today based on
the DECN August PR and Quarterly Report.
1. According to the August 10th PR, CEO Berman asked the FDA to reduce burdensome sensitivity requirements.
"Sensitivity" means the ability to detect people infected with COVID-19.
--- Answer me WHY your friend CEO Berman asked the FDA to lower the sensitivity requirements which is the key to test kits??
WHY??????
2. According to the Quarterly Report of August 14, DECN Serology test kits are suspected to be false negatives and blah blah . . . . . . due to a perceived lack of accuracy.
--- "False Negatives" means low sensitivity that the test kit cannot identify people infected with COVID-19.
plutoniumimplosion, if do understand what "sensitivity" and "false negatives" mean, you can't ask me the same stupid question over and over again.
--- I am really busy now. Most importantly, I am really sick and tired of answering your stupid repeated questions
Reread this company's PRs and repoft BEFORE YOU ASK ME.
NOW, YOU PROVE that DECN test kits can detect people infected with COVID-19 with 90% sensitivity.
Until you do prove that, I will NOT answer your question, MR. Smart Guy.
--- I changed my mind: I will not read your post from now on.
plutoniumimplosion, I pressed "Ignore this person."
Today's news release says that DECN expects to submit the new FDA application ( i.e. for DECN Saliva test kit) before the end of September upon completion of US-based testing with the about-to-be selected lab partner.
-----Today's PR reminds me of the news releases published twice in April and May : The company hopes to complete the FDA-mandated testing by mid-May.
In other words, we cannot gurantee 90% sensitivity of the DECN saliva test kit.
The SEC suspended based on the PRs of only March and April.
According to the SEC,
" . . . . . the SEC holds primary responsibility for enforcing the federal securities laws, proposing securities rules and regulating the securities industry, the nation's stock and options exchanges, and other activities and organizations, including the electronic securities markets in the United States.
The SEC has a three-part mission: to protect investors; maintain fair , orderly, and efficient markets; and facilitate capital formation.
In addition to working with various self-regulatory organizations such as the FINRA, the SPIC, and Municipal Securities Rulemaking Board (MSRB), the SEC also works with other federal agencies, state securities regulators, international securities agencies and law enforcement agencies."
Hello, mretgnol, mike, realwhiz, weebie, wynsurf, everyone.
How are you doing these days?
Thanks to nasty COVID-19, I refrain from going out as much as possible.
Even if you don't have a fever or cough, if you suddenly lose your sense of smell or taste,
suspect that maybe you are infected with COVID-19.
--- Let's all be careful not to get infected with COVID-19.
It is very uncomfortable to wear a facial mask in this hot weather, but I wear it when I go out.
Even through a person is completely cured of COVID-19, it is said that
the aftereffects do vary greatly depending on each person's immune system.
I hope you all stay healthy.
Have a nice day!!!
P.S., Today is a very good and meaningful day for me.
1. Two of my three wishes for 2020 have already been fulfilled.
2. I look on the bright side. --- I believe that my third wish will come true.
The SEC also encourages us to report misleading statements on COVID-19 produts.
timetravelerdos, the truth hurts???
I have offered the facts based on the DECN News releases, SEC Filings, Quarterly Report,
FDA updates, and other related news.
Have you mentioned any facts based on the PRs, SEC Filings, FDA updates, DECN' Quarterly Report before??????
1. Friday, June 26 : The company submitted the document including the testing results.
2. Monday, June 29 : The FDA sent the Acknowledgement Letter to the company. ( Read the letter.)
3. Thursday, July 2 : The FDA sent the EUA Registration number, which is the same as the EUA Submission number.
This Plexense, Inc. can sell its COVID-19 test from Thursday, July 2.
FYI, Plexense, Inc. is not listed in the stock market.
1. Pre-EUA stage :
It is a series of processes that an applicant provide related data and consult with the FDA
before submitting an Application for an EUA.
That is, it is the process of preparing an Application for an EUA in consultation with the FDA.
DECN is just in the Pre-EUA stage as stated in the July SEC file.
2. FDA's recommendation for an EUA Application & submission of an EUA application, NOT Pre-EUA Application
Unlike this DECN company which has never properly conducted the testing of its COVID-19 test kits during March, April, May, June, July and August,
"Normal companies" that are confident in their test kits finish the first or second testing at a reliable laboratory.
--- Once the COVID-19 test kit is validated based on the Testing results submitted by a company,
the FDA recommends applying for an EUA within 15 days.
In other words the company submits an Application for an EUA.
3. Submission of the FDA-mandated testing results conducted at a FDA-authorized laboratory, etc along with EUA Request like the Yale University research team.
4. FDA sends an Acknowledgement letter to a company after receiving the Testing data.
5. An EUA or an EUA Registration number to a company that meets the FDA criteria :
90% sensitivity & 95% sensitivity.
--- CEO Berman asked the FDA to "reduce burdensome sensitivity in the August 10th news releases.
What a crook !!!! --- The SEC lawyers have investigated this company due to fraudulent PRs.
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.
Sincerely yours,
Center for Devices and Radiological Health
DECN hasn't received this kind of Acknowledgement Letter like Plexense, Inc. --- If a company received this Acknowledgement Letter, you can find it from the FDA's website.
1. FDA sent the Acknowledgement letter on Monday June 29.
2. FDA sent the EUA Registration Number on July 2 that allows Plexense to sell its COVID-19 test from that day on.
Reread the above procedure and
PROVE that the FDA accepted the DECN's applications for an EUA. --- I do know you can't prove it.
Please do not ask me the same repeated question because rawman, IPwatcher et al already answered your question.
plutoniumimplosion, you said that you are pretty smart.
who here adnits you are a pretty smart???
ENOUGH IS ENOUGH. --- IF you don't understand, ask your friend, CEO Berman.
According to the DECN PRs, DECN had to complete the Testing by mid-May.
Ask your CEO friend, what has Berman done during March, April, May, June, July and August??????
plutoniumimplosion, do not avoid questions from JonnyC and others .
(big sigh) plutoniumimplosion, you really don't understand even if others and I already explained to you.
Can anyone help me understand based on the Quarterly Report and the April 7th PR???
The FDA is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease 2019 (COVID-19).
We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unapproved products and making false or misleading claims , including, by pursuing warning letters, seizures, injunctions or criminal prosecutions against products and firms or individuals that violate the law.
Reporting Problems to the FDA :
plutoniumimplosion never answers my question, either.
plutoniumimplosion still thinks that FDA did accept the DECN's Applications for an EUA,
never giving me any proof .
FDA did not even accept the DECN's Applications for an EUA. --- I already provided the proof in my posts.
Here is the evidence of PRE-EUA of DECN.
According to the April 7th news release,
plutoniumimplosion, After five months, CEO Berman started to confess
that DECN test kits are crappy.
plutoniumimplosion, Here's the proof of Pre-EUA Applications.
According to the April 7th news release,
plutoniumimplosion, PLEASE don't keep spreading false information and don't lie. --- A few iHubbers and I have provided the proof based on this company's PRs, Quarterly Report and the DECN's Response to SECthat the FDA didn't accept this company's EUA Applications, but you have never offered the proof that the FDA did accept DECN's Applications for an EUA and
keep saying the same "false information".
(FACT) : DECN has never properly tested its test kits for COVID-19 in the laboratory.
(FACT) : FDA didn't accept DECN's Applications.
--- Did the FDA accept DECN's applications for an EUA on what basis?????
--- Based on your impostor friend, CEO Berman's fraudulent PRs from MARCH 3rd ???
August 10th PR : FDA should reduce burdensome sensitivity.
August 14th Report :
DECN may shelve its serology tests due to False Negatives ( i.e. low sensitivity).
--- plutoniumimplosion, your friend, CEO Berman did confess that DECN test kits are crappy in five months.
I am waiting your proof. --- PROVE that the FDA accepted the DECN'S applications for an EUA.
(sighs) plutoniumimplosion, do not avoid the point.
I alredy prove that FDA did not even accept DECN's Applications for an EUA
based on the August PRs and Quarterly Report on August 14.
plutoniumimplosion, the FDA requests applicants to submit the results of clinical trials condected by a laboratory of the company's own choice.
Except for DECN, Which company doesn't do its own clinical trials (e.g. the so-called feasibility testing: the first testing or second testing) ???
plutoniumimplosion, don't avoid my question for you:
Can you PROVE that the FDA accepted the DECN's applications for an EUA ???
CEO Berman's PRs selling its test kits to Thailand, Brazil, Vietnam, etc.
plutoniumimplosion, Bottom line : FDA didn't even accept DECN's Applications for an EUA.
(deep sigh) plutoniumimplosion, I already provided the proof.
--- Read the the August 3? PR and the quote of the report in my post.
PROOF 1 :
Read the August 3 PR saying that the FDA is currently reviewing DECN's EUA applications.
PROOF 2 :
Five months later, the impostor CEO began to confess that DECN test kits are crappy.
DECN may shelve its serology tests due to False Negatives. - (Read the report on Aug.14.)
False Negatives mean low sensitivity .
That is, DECN test kits cannot detect infected samples.
timetravelerdos, Reread the Quarterly Report & August 10th PR, (not April 10th PR).
--- Berman's writing is as bad as mine: The first sentence is not good.
"On April 1, 2020 DECN planned to begin development ~ ~ ~
but are suspected to be false negatives. -- (This is the present tense.)
This product design is not yet in the advanced development cycle -- (This is the present tense) and
the company (i.e. DECN) may shelve this product because the FDA has recently clamped down on applications for direct antibody/antigen methods due to a perceived lack of accuracy.
--- Remember that DECN submitted its applications recently . -- (Read the August PR).
plutoniumimplosion, before you ask me , read the report several times.
There is an answer in the report.
To be very honest with you, I didn't click your post, but I can reply to you. Why?? You always ask some stupid questions.
(Correction) : Not the April 10 PR, but the August 10 PR.
DECN shareholders, do you know what this quote means??
plutoniumimplosion, your friend CEO Berman stated " vague expectations" in the quarterly report. - Read it again.
Anyway, does DECN have the RT- PCR technology for a saliva test??? --- Since when ???
Some shareholders and people closely related to CEO Berman have no credit at all.
Only to raise the stock price, they have claimed:
1. Raffis said that DECN's GenViro Saliva test is exempted from FDA regulations, so
DECN can sell the tests immediately. FYI, Raffis gave the "saliva test" idea to Berman.
2. The FDA EUA is imminent.
3. A CE mark is imminent.
4. DECN is a Real COVID-19 stock.
All COVID-19 tests must obtain an EUA or a FDA registration number at least before selling them.
Raffis, stop deceiving people.
plutoniumimplosion, read the DECN's PRs before you ask someone else.
FDA is not even accepting DECN's applications :
First, all companies submit the results of a COVID-19 test kit's performance testing conducted by an agency of choice by the company (e.g. DECN) without consultation
with the FDA as well as their application. However DECN didn't submit the testing results.
Second, The FDA-mandated testing results conducted in the U.S must be submitted within two weeks of an application.
--- Once again, DECN has NEVER even submitted its FIRST clinical trial results.
I can assure you that Berman will not tell the shareholders the results of sensitivity of DECN test kits even if the first testing in Korea is finished "someday." --- Why???
The answer is in the August 10 PR.
FDA Criteria/Requirements for an EUA : 90% sensitivity & 95% specificity
--- Berman publicly asked FDA to lower the sensitivity requirements in the August 10 PR:
(PR on August 10) " ..... reduce burdensome sensitivity requirements."
In other words, DECN's technology of COVID-19 test kits fall far short of that sensitivity requirement ( i.e. 90% sensitivity). --- CEO Berman has been hiding this fact from
smart?? shareholders for about 5 months.
plutoniumimplosion, your friend, CEO Berman claims that it's not because of DECN's technology that its test kit can't get an EUA, but because of the damn FDA.
You read what you said when your mind is clear.
Friday, August 7 : Was the stock price around 0.4??
"MADE MY $20,000. I’M OUT. EXTREMELY RISKY AND VERY DANGEROUS COMPANY WITH NOTHING TO SHOW AT ALL."
Friday, August 7 : "BE VERY CAREFUL WITH THIS COMPANY; IT’S WAY TOO RISKY."
Monday August 10 : So did you buy shares back at a cheaper price??
"I’M BACK FOR THE LIGHT SPEED ROCKET RIDE!"
Monday August 10 : "I WANT TO BE HERE FOR THIS TECHNOLOGY."
--- You sold all the shares for the same reason (i.e. DECN technology for COVID-19) last Friday , warning people that this company is extremely risky and very dangerous with nothing to show at all.
I do hope you make money in this stock, but please don't ...............
FYI, I read your posts a little while ago. --- I didn't know Berman released another PR this Monday until I visited the iHub today.
(big sigh) Raffis, wake up!!!
XyYou think about when CEO Berman was right about the timeline of completing
the FDA-mandated testing from April.
According to Berman, the testing should have completed by mid-May. It's August now.