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I'll believe when the order actually is paid for or ships. Remember, the company previously had many orders for the blood test kit pending EUA approval.
The PR only states the reception of the PO, but this PO could be contingent on the lab testing verifying the accuracy of the test kit. Now, that didn't work out for the blood test kit. I think they have a much better chance on the saliva kit as others have approved saliva kits.
But today's PR is not slam dunk proof that they are going to get a $5M check.
Not yet. Testing and test results is the key. The fact that DECN has never released any data from their extensive testing in South Korea is a red flag. Makes no sense to not release that data if it was positive.
Unless India allows for untested test kits being used in the country, no one is going to pay $5M for unproven test kits. If DECN gets and releases certified lab results within the EUA guidelines or good enough for foreign country approval, then the game changes and the company is a winner.
That may happen, but the cloud of this promise being imminent back in May for the blood test hangs over the promise of test results for the saliva test unfortunately.
Just wondering with the official international launch of Gen Viro Swift over the weekend why there wasn't a big PR this morning or some time today regarding the shipments, new orders etc.
Rather odd that a international launch is dated and PR'ed in advance, but then all goes silent on the day of and 1st business day after.
Rigorous testing, finalizing kits, but still tweaking the product.
No test results or data given and the launch will be for "professional", not home use:
They are working on it clearly, as OTCMarkets.com now has trading activity under the Quote tab of RVVTF, the News tab has been updated to include the recent PRs and the Disclosure tab was updated on 9/1/20 with a ton of past documents.
Previously, OTCMarkets.com only reflected RVVTF data up to 2018, so clearly a lot of work has been done to bring RVVTF up to date on OTCMarkets.com which is part of the requirements needed for the OTCQB uplisting.
Financials through 3/30/20 is up as well, so it shouldn't be long before they get approved unless something is lacking in the filing which I wouldn't expect.
OTCmarkets.com has the OTCQB Certification filing document dated Aug 26, 2020
OTCQB filing
So it seems like next PR could possibly be announcement of official clinical sites and when they will be accepting patients followed by a PR of first dosing of a patient.
If it happens within Sept, then they are on schedule and depending on how long it takes to get 211 patients enrolled, we will begin the countdown to first results.
Where did the company give any precise dates other than "in September" for the beginning of the trial?
Aug 19th PR:
Has there been a ruling in the Trading Suspension petition? It's now almost 2 months since the final paperwork was filed.
Amazingly quiet here after PR of an official launch date.
In prior PR, company stated it was getting kits for CE Mark testing. We haven't heard any results of that testing, but today they announce an official launch date of Sept 26 for international markets. They also state they are selling wholesale and each distributor is responsible for any certification necessary for sales.
So my question: is DECN going to submit the Swift Test kits for CE Mark approval or not? How can they launch the product without completing the testing? They are filling an order for 50,000 units to India, but is this for testing, free use or otherwise.
Seems like great news today, but there is still a fog as to what is the status of the kits and how well do they work.
Hard to know where things really stand as to the accuracy and usefulness of the test kits when all we get is the phrase of "extensive testing", but no data as to performance.
For what it is worth, I agree with you. The premise is simple and I don't understand how it is even a point of contention.
As you have stated, an insider buying large quantities of stock in his own company in the open market is different and a different trigger indicator than when insiders get stock, options or warrants as part of salary or incentive package.
They are not the same. Simple to understand. Everyone can pick their own favorite triggers or signs for investing, so what it the point of extensive arguing about it?
Thanks for the link.
- Still working on testing protocols with FDA for US testing.
- Focus on CE Mark approval for overseas distribution
- Still mentions both blood and saliva kits (interesting)
- Hoping for CE Mark approval by end of September
While continuing to state that DECN has a test and a test that "works", no clear statement on when US testing will occur as they continue to work with FDA on protocols for testing. Given the history of that statement going back at least to May if not before, that may very well mean DECN's opinion that the FDA must lower the testing requirements regarding sensitivity in order for DECN's blood test kit to be able to get EUA approval.
Given the company continues to state that testing is now ongoing in South Korea, they must have a pretty clear sense of what the data is showing regarding sensitivity and specificity. While they have made statements regarding specificity (meeting or exceeding FDA guidelines), they have been mute on any sensitivity.
However, the company has issued more than one PR giving their "opinion" on the need for FDA to lower the requirements of rapid tests.
Therefore, as others have expressed, it appears that DECN's testing of their kits (blood and saliva) may not meet the current FDA sensitivity requirements. If all their testing showed that the kits did meet those requirements, it should be headline news for the company to release and brag about.
In the interview, the PR man for DECN mentions that they hope for CE Mark approval as foreign standards are lower than the US FDA requirements.
Now, that may be enough for the company to get the legs it needs, but at this point, unless the FDA changes their standards, it doesn't look promising to expect FDA approval of either kit given the time, testing and statements in this interview.
The proof is in the PRs released by the company in March and the supplemental info filed with the SEC which, in the past, I had quoted extensively defending the company from what I thought was misrepresentation and attacks.
In those PRs and on the radio interviews, DECN stated repeatedly that they had a test that "worked", was fast and accurate and that had been tested in South Korea.
If you want to defend those statements as "true", because the meter turned on and gave a result, even if it was an inaccurate result, you are free to do so, but I believe those statements were clearly intended to make everyone believe the words as they were said, that DECN had modified their test strips and meters so that they had a test for Covid-19 that worked.
It has since been clarified that those statements were not true, as given by the company's own recent developments and statements as well as the documents filed during the suspension court case.
You can spin it any way you want, but it wasn't true. They do not have a finalized working test kit that meets FDA standards. If they did, it would be rather foolish not to submit the test and test data to the FDA for approval, wouldn't it?
Remember, the company stated testing in a US approved lab for the blood test kit was to occur before mid May. Hey, the post office and shipments can be delayed, but we were actually never told clearly why that didn't happen other than a PR stating they were waiting for final FDA guidelines on testing.
We are 3 months out from the blood kit testing promise given by the company and most of the latest news is about submittal of testing data for the new saliva test kits. I hope they do get those to work and if they do, the stock will rocket. But the saliva kits do not answer all the promises and statements made in PR and on radio about the blood test kits given in the past.
Everyone can take it as they want, but there is plenty of "proof" if you actually read all the PRs and filings of the company itself. It has not been transparent and honest in revealing all the setbacks and shortcomings of what had been promised. You can argue that they aren't legally responsible to do so based on the nature of the product development and that can be argued back and forth. But when a company makes statements to infer things that are not true, that is the definition of misleading.
I don't read it that way today. PR is very carefully worded to only refer to testing of negative patients, i.e. not giving false positives and refers not to current guidelines, but another person's opinion on what the sensitivity guidelines should be to approve rapid testing.
Furthermore, the fact that this PR continues to state that they are still adjusting the meter algorythms means that while the company has stated multiple times in the past that they had a test that works and works well, testing has proven that the test hasn't been meeting FDA requirements and that hopefully they are getting closer will any and all adjustments they have had to make since March.
The other issue that this PR only refers to the saliva and not the blood test further confirms my previous suspicions that the blood test for the active virus might be dead in the water, although if they can produce an effective anti-body test using the blood prick, that would be significant, but it is not mentioned here.
Having followed this since March, it seems the hope for DECN is in the saliva kit only for active virus detection and while prior PRs stated that the lab would already have been selected and testing begun by now, once again we are given a new deadline.
Based on the pattern to date, this appears to me to be the result that the company has not been transparent in sharing the obstacles and results of the testing of the kits. Such testing seems to have forced further changes to the reading of the test strips in order to give accurate results, something they are still adjusting.
In other words, they never had a test kit that worked in the sense of giving FDA required results, which to me, at this point, is fraudulent and given these facts, the PRs of March and April were misleading at best.
Will continue to monitor since if they ever do get the saliva test to work, they go to the head of the line for the fastest and least invasive of the COVID-19 tests.
Just that now we might not know if anything works until the end of Sept.
What are the opinions of why we haven't seen any judgement on the Trading Suspension yet? Documents deadline was over a month ago on July 15th as I understand it.
Here we are over a month later and nothing posted on SEC website.
If it can stay above .25 for more than 5 min, that might be your buy signal as those sitting at .25 or lower selling blocks of 100s of thousands of shares might be done for the day.
This much selling at .25 smells of converted shares from warrants tapping out their profits on news. Someone is just parking their shares around .25.
You are correct that material adverse information must be shared with shareholders. I believe the timeframe is within 3 days. I don't expect such news and bought RVVTF weeks ago.
Everyone that doesn't shout "To the Moon" is not against or adverse to the company. That would be a false assumption.
I look forward to getting good news soon and I've invested because I think it will come, but I'm not going to cry if it doesn't appear 10 min after the 30 day deadline. When and how the company releases that information will be up to the company and based on more than one internal factor. Investors and DT shouldn't be basing their decisions on whether or not the PR is released within minutes of the 30 day deadline.
Period.
AIMO
I don't know anyone who has denied that. Certainly, I have not so I don't understand your "replies" to my comments as they are not replies at all.
My statement was simply that the company may not release a PR the minute the 30 days has passed. That was my statement that you objected to and laughed at. Well, according to your calendar, when did the 30 days expire?
Trying to play mind-reader? You don't know me, so don't pretend to.
Stick to your trading and facts please. Will await the apology later if PR is not released. Wasn't today the deadline for the PR in your opinion?
In fact, if July 29th, at midnight was the 30 day deadline in your opinion, then the PR is already late according to your statements.
Yes. I'm real. Maybe you've had too many Old Fashions already and aren't thinking straight.
You seem to hold the opinion that every company runs on PRs the minute they can issue one is skewed in my experience. What do you think the CEO is more concerned about, the next PR? or making sure he can move forward on coordinating all the details of the potential clinical trials in 3 or more countries?
Time for you to get real. Companies don't exist for DT, as big as their heads and pockets may get.
Don't think management is worried about timing of PR, but more than likely working on aligning all the details to move forward on clinical trials in various parts of the world.
I would expect a PR sometime in the first week of Aug. 1st week of month is often time of portfolio changes and new investment monies going into companies.
Based on previous PRs and public information, not worried, but amazed that this has stayed below .20 for so long given what might take place over the next 3-4 months.
Can anyone explain the difference between "feasibility studies" and the FDA lab testing?
Obviously, I would think the feasibility studies are meant to verify that the tests work and are likely to pass the official FDA lab clinical studies, but since DECN has said since early March that they had a test kit that worked, what new level of info is to be had by feasibility testing etc.?
Yes, the company is entering a new phase to see if it can pass the spit test.
Humor aside, since there are approved saliva tests, if this proves to work it would be as big as the previous blood test and just replace it.
Question is how fast can they develop and confirm the accuracy and specificity of it? I didn't understand why the PR said no change to the test strip would need to be made. Saliva and blood are obviously different and the blood test strip for GenViro! was supposed to have 5 special layers and meant to lyse the blood cells etc. So, while potentially promising, this PR is also a bit confusing as to where things are at.
I'm trying not to be envious. I'm hoping my less than 14,000 shares help me to pay off the remaining mortgage balance.
Certainly feeling very positive about the potential of this stock right now and slow steady accumulation after the rapid sell off is a good sign.
Very interesting.
I think we can scrap the hope for a blood virus detecting test kit, but since saliva is known to be used for detecting the virus, this could be a saving change for DECN.
And it would also leave on the table, an anti-body at home test since the anti-bodies are plentiful in the blood (though it has been interesting that DECN has not commented much on the anti-body test as of late). Maybe the blood detection for either antigens or anti-bodies just proved too complex without the needed accuracy.
Don't know the challenges of saliva on a test strip, but the rabbit might still come out of the hat.
Has anyone discovered any information regarding who "Global Swift Sensor Distribution" is?
One reason the stock may not be taking off as fast as expected with the progress made is that the recent news about the stock is not posted in many areas people look for.
OTCMarkets.com is not reflecting any recent news. Once the news gets out more, would anticipate price going up much further.
Sorry, but you misinterpret the reason and intention of my reply. Go back and read please. If you want to promote a stock, don't post the articles that convey the opposite, simple as that.
Most treatments have side effects. Not bashing the product, just clarifying what the quoted article is actually saying.
Fress, do you realize that the article you cite as great is not a story of Bucillamine curing anyone, but instead bucillamine was the cause of a complication that was cured by "ceasing" the use of bucillamine?
Bucillamine-induced Pneumonitis
Great. Missed the month change there. That means they are even further along with the Canadian CTA plan. This could prove to be a huge month.
Very excited to see how this plays out.
Need some help here.
On June 30 Revive PR stated it had submitted FDA IND for phase 3 clinical trials:
TORONTO, June 30, 2020 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has submitted today its Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“U.S. FDA”) for a Phase 3 confirmatory study for Bucillamine as a potential treatment in COVID-19. Once the U.S. FDA allows the IND to go into effect, Revive will initiate a randomized, double-blind, placebo-controlled study of Bucillamine in patients with mild-moderate COVID-19 in Q3-2020.
The aim of the Company is to file its Investigational New Drug (“IND”) package to the U.S. Food and Drug Administration (“FDA”) for the proposed Phase 3 confirmatory clinical trial (“Phase 3 study”) this month and the Company also now intends to follow up with the submission of the complete CTA package for Health Canada around this Phase 3 study as part of the same multinational clinical strategy.
One last interesting note for today. The SEC filing states that the SEC did not have any of the third party information before them (slides, msg board posters etc.) at the time of the suspension, yet many posted about being in contact or writing to the SEC against DECN, so someone isn't telling the truth in that regard.
Doesn't look like "Global Swift Sensor Distribution" has a very big footprint. Can't find them in a Google search yet. Should be interesting to see who/what they are and if they were just created for this international distribution agreement deal.
Interesting that the PR is released immediately after the posting of the SEC's response to the trading suspension filing.
Pertinent for every investor: testing is ongoing internationally, but testing for US FDA submission has not taken place, in fact, the testing protocol has not been established or "agreed" upon, which is puzzling as to what is the issue. It either identifies the presence of the virus accurately against known sample of COVID-19 patient's blood or it doesn't, but maybe they are questioning how accurate the blood patient samples are?
The international agreements should help the bottom line, but without a verified product yet in GenViro!, my guess is that these contracts are more about GenUltimate and TGB products that can already be sold with GenViro! an add on product should it become available. And that is all about the testing and test results.
The fact that we don't yet have test result showing the accuracy of the product declared as working back in March (4 months hence) means that most likely there have been hiccups or unexpected results in the testing that has taken place thus far. Hopefully those impediments can be overcome and a working test will result.
But it raises valid flags for those who have invested based on the PRs of the past where it was stated in PRs and on the radio that the company had a test kit that worked and worked well, which can only mean one thing in an honest assessment, that GenViro! had been tested and gave accurate results showing the presence or non-presence of COVID-19.
We don't have that assurance today and until we do, this will be a stock flippers game gift of swapping in and out large volume sets.
The SEC response stated that as of the time of the suspension, the GenViro! test had never been tested against infected blood. We will see if the company refutes that in its final filing due July 15th.
Validate the test kits with accurate results and I'm all in - even if late, but without test results, all the past PRs have a shadow over them as to what had been stated.
Please note that the article being quoted is not about bucillamine curing anyone, but bucillamine being the cause of problems where the patient was cured by the cessation of the use of bucillamine.
In other words, bucillamine can have negative side effects in some patients being treated.
Tomorrow is SEC response deadline, unless they have been given an extension. That should shed some light on what they did or didn't know in response to the company's filing.
The one piece that would put an end to all the bantering would be conclusive test results, including those that we were told would be completed in a US lab by mid May.
Without conclusive test results, there are no sales regardless of how many millions have COVID-19.
That said, it may be possible that in the end the anti-body at home test gets approval while the other one that was designed to detect the virus/antigens does not. What that impact would be will depend on when that proves successful and receives EUA.
Right now, we have no clear test results data, and to me that is not an encouraging sign. If the company had it, there is no reason not to provide it as it would end all debates, get them off the grey markets most likely and roll in big investors and partners. Plus one would think that it would put them in the running for the gov special COVID-19 competition with up to 500M in assistance. A 15 second accurate test would be hard to beat, but there is no news on even entering the competition nor validation of test results.
Been a while since we had news with meat on it. I would not be surprised to see another PR before the posting of the SEC's response, but if it doesn't include test data or a clear update o the EUA process and where things are at, then....
JimB, need to be a little more gentle with the flipping. lol
Wow, that was a sudden surprise. Another leak at the SEC?
Last time it dropped like that was not a good day.
There are no MM and there is no shorting.
That's what is known.
The need is clearly there.
Any reason you can think of why the company has not yet given us an update on the US Lab testing referred to in the April 23rd PR?
It was to be completed within the next 17 days and a later PR stated that testing had begun.
DECN did post testing results temporarily on its website that seemed to come from THE BIO, not from a US Lab, but the data was posted in a way that was scientific data only without any explanation, so maybe scientists understood it, but there was no clear explanation of its significance to the specificity or accuracy for the general shareholder.
With the company wanting to line up distributors, demand and widespread knowledge of the product, I don't understand why the company has not given an update on the testing as we are told that both products are under FDA EUA review. If the review is to end in approval, obviously the test data is the main factor that everyone, shareholders, distributors and customers are interested in.
So, DECN submits their response 2 weeks past the deadline and it is posted immediately. Very interesting that someone on MB posted that it might be the case that both parties had agreed to an extension since I had left messages and tried to find out from SEC without any response as well as communicating with DECN and not getting an answer as to whether they had submitted a response.
It appears that this MB has SEC connected people fighting it out with DECN inside connected people.
Just wish I knew the real status of testing and the results since I didn't come here to flip price variations on large volumes of shares.