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Maybe Mayo is one of testing sites?
PR on 4-7
“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.”
Maybe he is not a native English speaker and he meant a game changer, not a world changer?
Maho meant to be Mayo? Or simple typo as 'h' is right below 'y'.
Osang Health, a Korean company, got FDA approval for their Corvid test kit last Friday 4/18; someone please reply with the FDA website.
I read somewhere that it took 3 weeks for Osang Health to get FDA approval after they got pre-EUA Acknowledgement.
It will take time to test 30 known Covid-19 positive samples and 30 known Covid-19 negative samples as FDA required the company in the last PR.
We may need to wait one more week or so. Hope sooner than later.
GLTA.
True. Big volume for an OTC stock.
10 x $ of my Nasdaq stock.
It seems that one test kit that uses saliva on CBC the other day got approved. Hope we’re the next.
Yes it is. Mr. Berman is dong right things, IMHO.
Haha that was good. I don't think DECN can compete with their device detects Corvirus 100 meters away.
Big thumbs up!!!!!
Closer than we think?
“A California company uses a existing diabetes monitor........”
It surely sounds like DECN.
Being mentioned on CBC does not guaranty FDA approval but it shows that FDA takes DECN seriously in their review.
I jumped in the ship less than a month ago at a spike; ups and downs in doubts.
I'm finally getting excited.
Thank you for posting.
GLTY
They obviously worked on last Saturday too.
That, I agree.
Market Cap
AYTU(NASDAQ): $120 mil --- x5 fold from $24 mil pre-Corvid MC
CODX(NASDAQ): $240 mil --- x5 fold from $48 mil pre-Corvid MC
BMRA(NASDAQ): $70 mil --- x3 fold from $23 mil pre-Corvid MC
DECN(OTC) : $26 mil ---- x7 fold from $3.6 mil pre-Corvid MC
Let's be realistic. You compared their pre-Corvid pps to pps of the highest moment of recent highs. For that, DECN did it twice already from 0.024 to 0.25 and to 0.30
After hitting 1000% their pps has come down to 300-500% gain.
If I apply that fact DECN doesn't have much room to move up. It's 700% up.
I'm just trying to see the reality here where too many are in fantasies.
GLTA
First, I hope the company be successful.
And I hope this is not what the CEO said to you,
"And DECN Does NOT need FDA approval to sell to these other countries....".
Hopefully it's just your words. If the CEO said such I'd say that he is planning a scam.
Do you think other countries do not have their own FDA and Decision Diagn can sell product freely?
That is a big flaw and lack of logic in anyone's thoughts.
From the PR on 3-18:
Today, DECN announces that the company is revising strategies (and forecasts) for its GenViro!™ Covid-19 test kit, a test kit that provides a coronavirus result in less than a minute, at the point of case. The company expects that it will receive a major boost from the most recent and thus far most optimistic FDA guidance for Coronavirus test kits.
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. The new FDA policy is available to read at: https://www.fda.gov/media/135659/download
This is from the company PR on 3-3:
DECN announces in this first of three releases, expected in the next 10 days, the introduction of our new screening methodology for the Coronavirus (Covid19). Our product is timely, simple to use, cost effective and will be commercial ready in the summer of 2020.
DECN is not one of 3 Korean companies got approval from FDA. Taken up too much.
Testing Kit development is not difficult.
Below is Google translation of an article by a Korean scientist on one of major Korean news media on 3-24-2020.
I think it shouldn't be too difficult for Decision Diagnostic Co to develop a testing kit for new virus.
We see many companies jumped in doing this business lately and sucessful. It's not like the company is developing a new drug.
And if FDA does not accept GenViro, the company can sell the products in other countries.
And of course you can not trust a small OTC company 100%. That is the dilemma here.
---------------------------------------------------------------------
Testing Kit development is not difficult.The most important thing is to find out the structure of a specific gene or genome of a corona virus. Corona virus has few genes, so experts can understand the overall nucleotide structure within a few days. Structures have already been identified in several places. You can make a kit by referring to it.
The order is like this. First of all, the target gene to be amplified is determined among the revealed genes of corona. Next, around 20 short oligonucleotides that can be attached to the end of the gene are synthesized. This is the key to kit development. This is called a primer and is necessary for amplification of the gene. Primer is necessary to synthesize a gene (see Figure 1 below). It is also easy to make; synthesizing can be done by a 3rd party company specialized for it.
There are several types of kits because the target gene to be amplified varies depending on the development company. Naturally, the resulting primers are also different. Only this difference. This difference may have some effect on accuracy, but it is not very different. Kit preparation is as simple as purchasing an enzyme that synthesizes genes and mixing primers, substrates (nucleic acid groups, nucleotides, A, G, C, T), and buffers. Of course, you need to get the product approval from the competent department. Here, the substrate is the building material for genetic synthesis (?) And is used by the purchaser. Buffer is a simple reagent that keeps the pH of the enzyme reaction constant during amplification. Five domestic small and medium-sized enterprises are producing in large quantities. Even during this period when demand explodes, there is still supply. You can purchase this kit in the field, add a sample, put it in a machine (thermal cycler) and follow the manual.
Samples are collected by scraping them with a cotton swab deep into the nostrils or throat. Theoretically, you only need one or two viruses. If it is collected incorrectly, it may come out negatively. Sneeze splash or cough sputum is better than these samples. As a sample of PCR, a sample (eg, RNA) extracted by melting a virus with an enzyme in a test tube is used as a sample. A very small amount of genome is amplified and amplified the target (target) gene by PCR.
[Source: JoongAng Ilbo] [The Longer] The World's Surprised Corona Test Speed, How to ...
It seems there are multiple testing kits by multiple companies being reviewed. The one used in Singapore is just one of them.
https://www.scmp.com/week-asia/health-environment/article/3073905/coronavirus-singapore-launches-new-fast-track-swab
Someone kept on supplying shares endlessly and the other end kept on slapping asks?
Daily chart look bizarre..............I’m speechless.
Just saw it on the chart. How pps is precisely controlled, like hair cut, with all BYU’s.
All tickers got hit big past couple days are now up more than 10% except AVXL- 1%. Why?
I agree. I don't believe numbers from China and Iran.
Anavex at 2020 Epilepsy Pipeline Conference
Mar 12-14 in Santa Clara, Calif
Hope the conference is not canceled due to Corona-19.
Edit- Just checked and it is postponed. No date yet
-------------------------------------------------------------
Day 2 Mar-13
Session IX Continued: Rare And Ultra-Rare Diseases – 1:20-3:20 P.M.
KB-3061, Knopp Biosciences – Steven Dworetzky PhD, Vice President of Discovery Research
Tak-935/OV935, Takeda Pharmaceuticals – Mahnaz Asgharnejad PharmD, Vice President of Clinical Development
UX-068, Ultragenyx – Melanie Brandabur MD, Medical Director
VAL-0417 and VAL-1221, Valerion Therapeutics – Matthew Gentry PhD
XEN-496, Xenon Pharma – Ernesto Aycardi, Chief Medical Officer
ZX008, Zogenix – Glenn Morrison PhD, Vice President of Global Clinical Development
Anavex 2-73, Anavex Life Sciences – Walter Kaufmann MD, Chief Medical Officer
AE116, Aeovian Pharmaceuticals– Stelios Tzannis PhD, President & CEO
Natalizumab, Biogen – Kim Parkerson MD, PhD, Medical Director, Epilepsy and Neurodevelopment
PRAX-330, Praxis Precision Medicines – Kiran Reddy MD
NBI-921352, Neurocrine Biosciences – Dietrich Haubenberger MHSc, MD, Medical Director, Early Clinical Development
Epidiolex for Tuberous Sclerosis, Greenwich Biosciences – Farhad Sahebkar MD, Senior Medical Director
I don’t get why AVXL is getting hit harder than other bio stocks.
‘promising’ medicines
Yes! Dr. Harald Hampel called it 'promising Anavex' in his messages on FB in early Dec 2018.
I wondered what he was based on..........
AVXL$$$
Right!
What a defense with more buys!!
15--> 10--> 8--> 14--> 15--> 19
That makes sense. The article is talking about failed Alzheimer drugs rather. Need to be careful.
Interesting that the article has a link to Anavex story they made in 2018. I appreciate their efforts. ??
AVXL$$$
"........but several leading Australian experts say the results raise serious questions about the direction of Alzheimer's research."
They are getting close to Anavex, I hope. Hot, hot, hot....
Unfortunately the article does not mention Anavex, only the link to 2018 article of Barrie Pittock (Nobel peace prize) on Anavex 2-73 trial.
Thanks.
Thank you for your post!
AVXL$$$
Your next investment plan is good only if you missed 30% gain after readout.
But I doubt you will miss 30% only for the most bio stocks.
And hope not you expect only 30% gain after AVXL readout.
edit: Oh you answered to Xena already about my point re:AVXL.
.
With the monster news its needle hasn’t moved testing my patience. Not that I will do anything as I’ll hold till start of production and beyond.
Financial deal they have been working past years will be signed any day now.
Oh, ok. : )
It is a peer reviewed article. I found it on a pop-up right below the title of the article TTT linked.
It might not necessarily be the one Dr.M was talking about.
What are journal pre-proofs?
Journal pre-proofs are Articles in Press that have been peer reviewed and accepted for publication by the Editorial Board of this publication. They have undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but are not yet definitive versions of record. These versions will undergo additional copyediting, typesetting and review, and may not yet have full ScienceDirect functionality. For example, supplementary files may still need to be added, links to references may not resolve yet, etc. The text could still change before final publication.
I think it's a person. Can I ask why you buy stocks?
Yup. I did not sell a single share last year but sold 3000 shares in January for a short trade. Hope I can make up on the other. I'm not gonna cry. I am a grown-up. Lol
AVXL$$$
Thank you for letting me know. lol
It is being a MONSTER run. All the recent gain is made in February.
The last day we saw 2's was 1/31 @ 2.86 = 103% up in Just February!!
It's crazy.
A good way to start the first day of week! 16% up.
I have begged for $6 back past 2 and a half years. sheesh
You bet, all had this am. No messages from 9:37 to 1:03 pm
Verry good call. SP on 1/31 was @ 2.86.
102% Up since.
Yup I don't believe dead money theory, especially bio-stocks.
You will never know.
AVXL$$$
You have a nice story there. Thanks.