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'FEARANDGREED'...In line with the topic "AYTU/Cedar-Sinai's deal," my family is very intimate with Cedar-Sinai Medical Center. Besides having friends and family who work there, a neurologist diagnosed a spinal cord tumor in my wife's spinal canal a number of years ago. Therefore, be mindful that I am fully aware and very engaged with their legitimacy.
In closing, please consider my comments and thoughts as part of my "due diligence tool-box."
Be well and be safe...Cheers!!!
'Drugdoctor'...Nonsense... It could become mainstream therapy for certain conditions..
With all the valuable information that has been so tirelessly provided, it begs the question...
"Why has the PPS not performed accordingly?"
'Dragon Lady'...Based on all the valuable information that you have so tirelessly provided, please impart some insight as to why the PPS is not tracking accordingly.
TIA...
Cedar Sinai MD's TWEET ABOUT AYTU DEAL !
TELL THEM TO STOP, IT'S NOT HELPING THE SHARE PRICE!!!
'BluSkies'..."How did a DIY at test at home kit get FDA approval before this?"
This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.
'daleb2130'...So, "Buy" bought 953,419 shares of the 1,857,580 shares that "Sell" sold...
...then who bought the other 904,161 or so shares that "Sell" sold???
'Dragon Lady'...AYTU is now PARTNERED WITH A WORLD LEADING "NAME RECOGNIZED" research hospital with USC/GEFFEN
$AYTU/Gene Biotech is AUSTRALIA APPROVED :)
Zhejiang Orient Gene Biotech Co Ltd (China), 1 April 2020, 14 April 2020,
'Dragon Lady'...Question: Does this mean that that this supposed "Acknowledgment Letter" for Healgen Scientific (a subsidiary of Zhejiang Orient Gene Biotech Co., Ltd.), COVID-19 IgG/IgM Rapid Test is not valid? I was hoping that it would eventually flow into AYTU's distribution effort...
3/23/2020
Acknowledgment Letter
Jinjie Hu, President and Principal Consultant
Axteria BioMed Consulting, Inc.
8040 Cobble Creek Circle
Potomac, MD 20854
UNITED STATES
Dear Jinjie Hu:
The Center for Devices 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. All future correspondence regarding this submission should be identified prominently with the number assigned and should be submitted to the Document Control Center at the above letterhead address. Failure to do so may result in processing delays. If you believe the information identified below is incorrect, please notify the Program Operations Staff at (301) 796-5640.
Submission Number: EUA200056
Received: 3/23/2020
Applicant: Healgen Scientific LLC
Device: COVID-19 IgG/IgM Rapid Test Casette (Whole Blood/Serum/Plasma)
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. For information about CDRH review regulations and policies, please refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
Sincerely yours,
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Not too worried regarding today's chain of events. There are some influential entities involved. For example, there is the University of Southern California, Los Angeles County and Stanford University. Then there is the husband and wife team behind Premier Biotech, who won't take this sitting down, and will be very "hands-on" in correcting the the issues regarding the test kits.
Cheers!!!
BINGO ! AYTU can sue NBC FOR LIBEL - EASILY !!
There is no such thing as "Chinese FDA" approval LMAO !!
But some COVID-19 antibody tests, including those being used by public health departments in Denver and Los Angeles and provided to urgent care centers in Maryland and North Carolina, were supplied by Chinese manufacturers that are not approved by China's Center for Medical Device Evaluation, a unit of the National Medical Product Administration (NMPA), the country's equivalent to the U.S. Food & Drug Administration, NBC News has found.
From the CEO himself..Just have to read the article...
Josh Disbrow, chief executive of Aytu, confirmed to NBC News by phone that Zhejiang Orient's tests have not been approved by the NMPA. He emphasized that the tests have been validated in a study by third-party clinical researchers.
Bit of a sticky wicket. That study might be put on hold for awhile.
Cheers!!!
Please read my previous post date 2-3 weeks back.
'Esclav'...From the article you reference...
The Major League Baseball are volunteering for antibody testing after being asked by researchers from Stanford and USC.
Sood and other professors from USC and Stanford University are working with L.A. County officials to conduct the testing at six sites, which will include the parking lots of clinics and libraries.
Sood said the test kits - which are from the Minneapolis-based company Premier Biotech - were donated to him by a private individual who read his March 15 Wall Street Journal op-ed arguing for the importance of conducting large-scale randomized testing. He received a supply of 5,000 kits, which the county plans to use for testing every two weeks.
...Test Kit manufactured by Hangzhou Biotest Biotech Co.,Ltd....
"...the Company expects to file the 2019 10-K no later than May 14, 2020..."
Form 8-K that Jason filed today, April 14, 2020.
https://www.otcmarkets.com/filing/html?id=14073314&guid=WUnWU6q4kYYWC3h
'no_ur_stox'...Perhaps this will aid in your understanding regarding "NO REVERSE SPLIT!"
On March 24, 2020, Aytu BioScience, Inc. (the “Company”) received a letter from Nasdaq Regulation, a division of The Nasdaq Stock Market LLC (the “Nasdaq”) notifying the Company that the Nasdaq has determined that the Company’s stock price has traded above at least $1.00 for at least 10 consecutive business days since the previously announced February 19, 2020 notice, and therefore, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), commonly referred to as the Bid Price Rule.
'igotthemojo'...Appreciate your reply...However, I am trying to bring focus to the information in the "Acknowledgment Letter," namely, the Submission Number: EUA200056.
Why does Healgen Scientific LLC have a Submission Number for aCOVID-19 IgG/IgM Rapid Test, when it appears that Aytu BioScience Inc (AYTU) does not?
Why is Jinjie Hu, President and Principal Consultant, from Axteria BioMed Consulting, Inc. spearheading the same COVID-19 IgG/IgM Rapid Test that Aytu BioScience Inc has exclusive rights to distribute the product in North America?
After all, "Zhejiang Orient Gene Biotech Co., Ltd. (often referred to as “Orient Gene”) did acquire 100% interest and is the sole owner of Healgen Scientific."
Pretty straight forward.
Submission Number: EUA200056
Received: 3/23/2020
Applicant: Healgen Scientific LLC
Device: COVID-19 IgG/IgM Rapid Test Casette (Whole Blood/Serum/Plasma)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154927986
Found by accident a "FDA Acknowledgment Letter" with an "EUA Submission Number" for a Healgen Scientific, COVID-19 IgG/IgM Rapid Test. Curious if anyone has seen this before.
A reminder: "Healgen Scientific was established by a team scientists in Houston, Texas, and has been collaborating with Zhejiang Orient Gene in developing Health care products. Zhejiang Orient Gene Biotech Co., Ltd. (often referred to as “Orient Gene”) acquired 100% interest and is the sole owner of Healgen Scientific."
3/23/2020
Acknowledgment Letter
Jinjie Hu, President and Principal Consultant
Axteria BioMed Consulting, Inc.
8040 Cobble Creek Circle
Potomac, MD 20854
UNITED STATES
Dear Jinjie Hu:
The Center for Devices 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. All future correspondence regarding this submission should be identified prominently with the number assigned and should be submitted to the Document Control Center at the above letterhead address. Failure to do so may result in processing delays. If you believe the information identified below is incorrect, please notify the Program Operations Staff at (301) 796-5640.
Submission Number: EUA200056
Received: 3/23/2020
Applicant: Healgen Scientific LLC
Device: COVID-19 IgG/IgM Rapid Test Casette (Whole Blood/Serum/Plasma)
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. For information about CDRH review regulations and policies, please refer to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
Sincerely yours,
Center for Devices and Radiological Health
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
'Brian28'...If you want to be privy to that kind of accountability by the company, than you would need to request your share certificates and become a "shareholder of record."
Otherwise, as a retail holder of shares "in street name only," your rights to access certain information is is of no issue to the company.
Regarding the "PR about the 2750 test kits to Denver 1st responders!," that's all it was, a "PR" wrapped around "Denver's First Responders," a legitimate piece of public relations, branding and advertisement.
It doesn't get any better than that except for when financial reporting comes around. Oh, and wait for the FDA Approval, sparks are going to fly when the the company does and 8-K filing and PR.
It's your call should you choose this line of inquiry. If so, be prepared for perpetual frustration moving forward from this day to the next.
In the meantime, "catch the dips and sell the rips."
Again, just chill and ride the wave.
Really Huge!!! It's for, are you ready? "...hand-sanitizing preparations, all-purpose disinfectants, and disinfecting wipes."
WOWZA!!! TO THE MOON!!!
Last weeks Volume.....No visual required...and not "Fake News"
04/03.....16,258,900
04/02.....19,689,100
04/01.....18,368,700
03/31.....15,547,800
03/30.....22,503,800
Total Volume 03/30 thru 04/03.....92,368,300
Average Daily Volume.....18,473,660
https://finance.yahoo.com/quote/AYTU/history?p=AYTU
04/09.....9,489,100 (that one happened to be correct)
Noted...And thank you as well for your keen and piercing insight into the affairs of $AYTU!!! Most helpful!!!
Collecting all of the as you call them, "Nothing burger ALERT !('s)" to add to my "perpetual-DD-Puzzle."
Appreciate your assistance and effort in the matter...Thank you.
Be well and be safe.
Noted...Thank you.
"Zhejiang Orient Gene Biotech Warned By Securities Regulator For Information Disclosure Violation"
https://www.reuters.com/article/brief-zhejiang-orient-gene-biotech-warne/brief-zhejiang-orient-gene-biotech-warned-by-securities-regulator-for-information-disclosure-violation-idUKP8N2AY03W
Need translation...
http://static.sse.com.cn/disclosure/listedinfo/bulletin/star/c/688298_20200309_1.pdf
Yup...per the link you referenced..."Studies on the tests done in Spain found that they had only 30% sensitivity, meaning they correctly identify people with the virus only 30% of the time, sources told the Spanish newspaper El País."
Begs the question: "Is that what is being learned about $AYTU?"
The $AYTU COVID-19 IgG/IgM Rapid Test seems to be falling on deaf ears at the FDA. Had a great call today with diagnostic test developers to receive their input on finding more solutions to make available accurate serological tests that identify antibodies to #COVID19 during this public health emergency.
Could it be possible that questions are being raised about the accuracy and adequacy of information $AYTU has supplied to the marketplace?
Also, why are the offerings taking so long to close? Are there some shenanigans behind the efforts to raise capital?
Far too many questions, very little information why the share price remains so. let us say, "FLAT?"
Hopefully, no questions are being raised about the accuracy and adequacy of information $AYTU has supplied to the marketplace. The U.S. Securities and Exchange Commission has announced the temporary suspension of numerous companies due to their questionable promotional activity.
$AYTU...GOT SOME MAJOR COMPETITION FORMING OUT THERE... Testing for COVID-19 has been somewhat of a roller coaster in the last few weeks. With each day, the FDA pushes forward in its efforts to expedite the review and rollout of sorely need COVID-19 diagnostic testing. It has enabled the Emergency Use Act, which relaxes standards during a time of crisis.
On March 30 the agency revealed that, since January, it has worked with more than 230 test developers – who have either already submitted requests for FDA emergency authorization of their product or are expected to submit. It also specifies that 22 have already been granted authorization.
https://www.mobihealthnews.com/news/latest-covid-19-testing-fda-updates-ready-responders-land-48m-administer-covid-19-tests-home
SADLY, NO MENTION OF $AYTU.
'scottyb'...$AYTU...NOTHING MORE THAN A SMALL DISTRIBUTORSHIP OPERATING OUT OF A SMALL BUSINESS PARK...TOTAL OPERATION ALREADY BAKED IN THE SHARE PRICE. TOO BAD, HAD HIGH EXPECTATION.
$AYTU PR-FLUFF HAS RUN ITS COURSE...THE MOST RECENT HAS EXPIRED...ONLY CLOSING OF OFFERINGS AND THE MUCH TALKED ABOUT "FDA APPROVAL" REPORTED VIA SEC FILINGS WILL KEEP THIS COMPANY AFLOAT.
OLD NEWS!!!......"$AYTU: Shipped 10% OF ALL USA COVID-19 TESTING !"
'no_ur_stox'....NOTED REGARDING YOUR POSITION IN $ATYU. GLTY!!!
EVEN WITH GOOD NEWS, THOSE WHO HAVE PURCHASED SHARES (ME INCLUDED) IN THIS COMPANY HAVE BEEN BAMBOOZLED.....GLTA!!!
REMEMBER THIS: $AYTU IS NASDAQ COMPLIANT...NO REVERSE SPLIT!!!
...Company’s stock price has traded above at least $1.00 for at least 10 consecutive business days since the previously announced February 19, 2020 notice...
Then provide one from a qualified/verifiable source.
Quote:
'Dragon Lady'...Do you have a link to a study stating "$AYTU: SAFEST COVID-19 TEST IN EXISTENCE?"
Yes :)
'Dragon Lady'...Do you have a link to a study stating "$AYTU: SAFEST COVID-19 TEST IN EXISTENCE?"
'Dragon Lady'...Do you have a link to a study stating "$AYTU: SAFEST COVID-19 TEST IN EXISTENCE?"