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The bounce is upon us. Please remember to take profits into strength.
$AXIM 10sma crosses 20sma after double .055 bottom. Increasing OBV. Increasing Momentum. RSI in 50’s. Watching closely
this stock is a swirling squirrel turd, if there is a bounce, it is a dead squirrel bounce
Who is this Johnny Drago character and how is he related to AXIM? Is he somehow affiliated with the company - via employment or services arrangement - or information on this board?
Regarding John Drago, so called expert and seer, who pretends to know about AXIM. Please note the last paragraph. Beware those who place their trust and money in the opinion of Drago.
"May 27, 2022
United States v. John Drago
18-CR-394 (S-1)(GRB)
Dear Judge Brown:
The government writes in response to the United States Department of Probation’s May 17, 2022 Presentence Investigation Report (“PSR”) concerning the above captioned case. Paragraph 28 of the PSR incorrectly deducts one point from the defendant’s Total Offense Level based upon the defendant’s “timely acceptance of responsibility.” (See PSR at ¶ 28 (citing U.S.S.G. § 3E1.1(b)). As set forth in the parties’ Plea Agreement, however, the government will not be making a motion for an additional point deduction.
This is because the government expended significant effort in preparing for trial in this case, including litigating the admissibility of more than 250 exhibits in two complex pre-trial suppression hearings.
In addition, the PSR contains inaccurate information concerning the defendant’s military record. (See PSR at ¶62). To provide the Court with correct information concerning the defendant’s time in the military, the government will be filing an additional letter and documents obtained from the United States Army under seal."
Website has a CLIA application page.
https://aximeye.com/clia-application-process/
Here is a cut/Paste of first few paragraphs.
CLIA Application Process
NOTE: In New York and California, only MDs & DOs currently meet the State Lab Director requirements needed for certification and operation of moderate complexity point-of-care lab tests; on their patients. Optometrists do not currently meet the requirements for performing moderate complexity tests in those states. In all other states, MDs, DOs and ODs (optometrists) may serve as Lab Directors. Additionally, ODs are waived from having to take the CLIA 20 CME course.
CLIA certificates for moderate complexity lab testing are called Certificates of Registration (COR). Each COR is good for two (2) years and costs $150, to cover Federal CLIA’s costs for issuing the certificate. This fee is paid to Federal CLIA once every two years.
The Complete CLIA Application Packet: The following is a list of all items that must be included in the CLIA Lab Director application.
Form 116: completed and signed. The State of Washington is the only state that does not use the Form 116; rather, it uses the Accredited Medical Test Site License Application.
Copy of Diploma: MDs or DOs, and ODs where allowed
Copy of CV
Copy of State License, and
I would also think there are Plenty of places that are already CLIA certified.
In-office labs
If a provider is performing the laboratory service in their office, and their lab is CLIA certified, the services can be filed directly with Blue Medicare HMO or Blue Medicate PPO for reimbursement.
https://www.bluecrossnc.com/node/51041
How long does it take to get your CLIA?
Depending on your state health department, it can take between 4-12 weeks to receive your CLIA certificate. The CLIA certificate of waiver is necessary for state and federal compliance, and provides the benefit of facilitating provider reimburse- ment for the use of CLIA-waived tests.
Thank you for sharing.
This is the first step to start selling these tests.
One of the main points is that eye doctor offices will have to become CLIA compliant to purchase and use these tests in their practice (Until the FDA grants a CLIA Waiver.)
We all know how frustrating it is waiting on the FDA.
-- Guidelines for the CLIA application process, a requirement for
optometrists and other medical doctors looking to purchase, use and bill CMS for AXIM's tests.
AXIM Launches New Eye Care Website; Establishes Platform for Commercialization
9:01 AM ET 6/2/22 | GlobeNewswire
AXIM Launches New Eye Care Website; Establishes Platform for Commercialization
SAN DIEGO, June 02, 2022 (GLOBE NEWSWIRE) -- AXIM Biotechnologies, Inc (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting ocular surface diseases, today announced the launch of its new mobile-optimized website designed to provide doctors, researchers and other medical professionals with tailored, timely information and resources that will enable them to make informed decisions when purchasing AXIM's proprietary diagnostic tests.
This new AXIM Eye website features:
-- Information about AXIM's optimized Point-of-Care FDA 501(k) cleared tests
for Lactoferrin and IgE designed to accelerate the diagnosis of Dry Eye
Disease and ocular allergies.
-- A research library where stakeholders can learn more about the biomarkers
that AXIM's tests are detecting.
-- Guidelines for the CLIA application process, a requirement for
optometrists and other medical doctors looking to purchase, use and bill
CMS for AXIM's tests.
-- An easy-to-use order form for those who have completed the CLIA
application process.
"This new comprehensive website provides every visitor with the information they need to understand our products and place purchase orders," said John W. Huemoeller II, Chief Executive Officer of AXIM(R) Biotech. "We are optimistic that it will greatly increase awareness of our offerings and help us streamline our sales process as we continue to grow. As a part of our goal to help save doctors time and money by speeding up the diagnosis of a multitude of ophthalmic conditions, we hope that this website makes it easier than ever for them to purchase the tools they need."
To learn more, please visit https://aximeye.com/.
About AXIM(R) Biotechnologies
Founded in 2014, AXIM(R) Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease. For more information, please visit www.AXIMBiotech.com.
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim's eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company's diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim's SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
CONTACT
Public Relations
Kathryn Brown, Account Director
CMW Media
P. 858-221-8001
kathryn@cmwmedia.com
AXIM Corporate
6191 Cornerstone Ct., Ste. 114
San Diego, CA 92121, USA
P. 858-923-4422
Investor Relations
investors@aximbiotech.com
888-759-0844
> Dow Jones Newswires
June 02, 2022 09:01 ET (13:01 GMT)
The cost of freedom.
So we are going to be paying for his housing/ meals for the next couple of years?
He is too busy trying to get the sentencing judge to grant a continuance and the government having an issue with his military service amongst other concerns regarding his conviction.
Buying into the DED business at 5 cents per share might be an opportunity. What does the squirrel think at this juncture?
Agreed. You can judge a company by the type of investor it attracts. AXIM obviously is a trading stock and one can know this due to the extensive concentration of information publicly available showing potential revenue streams and when that stream fails to turn into a river of revenues, a new revenue stream makes an appearance. Eventually under the arid environment it all dries up and fades. AXIM is just another tiny pink shite company with just enough swill to keep some investors feeding at the trough.
Be safe this holiday weekend and watch out for the Monkey Pox. I hear it's a lot like shingles. Maybe Douglas Lake has something up his sleeve on that front.
They are falling short in that calling as well....
You must not be a humanitarian. AXIM has a higher calling than just making investors wealthy.
That may be true but unfortunately this ticker will not help anyone be financially free...
We are on the verge of all sorts of new medical technologies being rolled out replacing traditional medicine. Immortality awaits.
Alcon paid $60 million to purchase Annual Revenues of $11 million.
Maybe they think they can grow the new acquisition??
Very Interesting.
$AXIM
Alcon to pay $60 Million for Kala Pharmaceuticals
#Eysuvis and #Inveltys products.
In this space, Alcon could be a buyer of AXIM DED Eye segment.
Just Saying.
Just putting this out there.
It could happen.
Not saying it will happen.
But it could happen.
https://buff.ly/39JnU0f
The conversion on the recent note is based on the lowest two closing prices in a 10 day period. Allowing for the holiday and 4 days for the 8k if last Friday and Monday are the low closes for the 10 day period I expect an 8k on or before June 10. If the note doesn't convert at a low price it reverts to the fixed conversion price. It will be interesting to see if the note holders are sufficiently bullish to convert their notes or if they wait and see with the slightly higher conversion price locked in. If they are waiting for a lower conversion price they are competing with our new buyer for shares. The 10Q didn't use the entire extension period for the first time ever so it will be interesting to see if there is a note conversion reported on an 8K in a shorter time frame as well.
Barry Craig is a KEY hire.
AXIM however still has some hurdles to jump before sales start.
Either the eye doctors offices have to become CLIA compliant or these tests have to be sent to a CLIA approved lab.
OR the FDA has to provide a 510K Class II CLIA waiver so these tests can be performed by eye doctors.
Until the FDA provides a CLIA Waiver,
The 7 minute time savings on the test is meaningless.
This News Release did not provide the most relevant information. Information that was released just yesterday.
The DED initiative seems to be rolling out without a hitch. Its very encouraging to see the company executing.
Read page 42 of the 10-Q from yesterday (Monday 5-23-2022).
Let me make it easy. This is a Cut/Paste from Page 42 of the 10-Q.
"Market demand for the system is expected to be moderate to begin with until we become a preferred vendor with a large purchasing group or until we are granted a waiver from CLIA. At that time we expect high demand for our system. We also expect high demand for our recently developed MMP-9 quantitative test once we get FDA 510k clearance. While we must compete with other capital equipment expenditures under consideration in any ophthalmic physician?s office, we believe that no other ophthalmic device offers the combination of compelling clinical and financial benefits afforded by our system. The clinical utility of the tests offers important diagnostic precision, differentiation and treatment management direction. Inner-office efficiencies significantly improve the patient flow characteristics, reducing patients in office visit time and greatly reducing physicians chair time with each patient."
The stock is performing well so far today. If the bottom is really in we should see a note conversion 8K by Monday.
What this release fails to mention is the FDA Approved 510K test is a Class II test and has to be performed at a CLIA approved lab.
Until AXIM receives a waiver from the FDA all of these tests have to be sent to an approved lab.
Or the eye doctors office has to become CLIA compliant.
I believe page 42 of the 10-Q is a more honest representation of the truth.
XIM Biotechnologies Completes Optimization of Only FDA-Cleared IgE Rapid Diagnostics Test -- In-House Manufacturing Lowers Cost and Eliminates Supply Chain Expenditures
9:00 AM ET 5/24/22 | GlobeNewswire
AXIM Biotechnologies Completes Optimization of Only FDA-Cleared IgE Rapid Diagnostics Test -- In-House Manufacturing Lowers Cost and Eliminates Supply Chain Expenditures
SAN DIEGO, May 24, 2022 (GLOBE NEWSWIRE) -- AXIM Biotechnologies, Inc (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting ocular surface diseases announced today that its scientific team has completed the optimization of a rapid diagnostics test for the quantitative measurement of Ocular Immunoglobulin E (IgE), a biomarker for ocular allergies. The test is a simple, rapid, and non-invasive immuno-chromatographic test that enables the identification of allergic conjunctivitis in one single step.
This quantitative test is the only FDA-cleared and reimbursable rapid test for IgE and is of high clinical utility in the confirmation of the presence of active ocular allergens. AXIM acquired the technology for this test and has since been optimizing the test to provide quicker and more accurate results. The test when acquired was a 15-minute test and the development team has been able to miniaturize the test and reduce time to result to seven minutes.
"Until recently, few allergy testing options were available for in-office use by primary eye care providers, and we want to be leaders in changing that," said John W. Huemoeller II, Chief Executive Officer of AXIM(R) Biotech. "Because we've cut the time of giving the test in half, we can give doctors the opportunity to test double the number of patients every day and, since we will be manufacturing the test in-house, we firmly believe that it has the potential to be a profitable new offering."
Although approximately 40% of the general population experiences allergic conjunctivitis, it is often underdiagnosed and consequently undertreated due to the lack of diagnostic tools. AXIM's rapid IgE test helps in the assessment of total tear IgE levels and is useful for the clinical diagnosis of allergic conjunctivitis and its severity. The presence of an allergen often mimics the signs and symptoms of Dry Eye Syndrome associated with aqueous deficiency and evaporative dry eye or both.
About AXIM(R) Biotechnologies
Founded in 2014, AXIM(R) Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease. For more information, please visit www.AXIMBiotech.com.
Forward-Looking Statements
The statements made by Axim Biotechnologies Inc., in this press release may be "forward-looking" in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim's future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim's eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company's diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim's SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
CONTACT
Public Relations
Kathryn Brown, Account Director
CMW Media
P. 858-221-8001
kathryn@cmwmedia.com
AXIM Corporate
6191 Cornerstone Ct., Ste. 114
San Diego, CA 92121, USA
P. 858-923-4422
Investor Relations
investors@aximbiotech.com
888-759-0844
> Dow Jones Newswires
May 24, 2022 09:00 ET (13:00 GMT)
If the quote from Page 42 is true. . . .if sales stumble out of the gate, AXIM share price may not be at a bottom yet.
It now costs a lot more shares to pay bills and salaries.
Mr John Huemoeller makes $35,000 a month. There are currently 6 employees plus expenses.
AXIM currently has to sell between 1.5 million and 2.5 million shares a month just to stay in business.
Bottom line Quote from Page 42 of 10-Q
Market demand for the system is expected to be moderate to begin with until we become a preferred vendor with a large purchasing group or until we are granted a waiver from CLIA.
At that time we expect high demand for our system. We also expect high demand for our recently developed MMP-9 quantitative test once we get FDA 510k clearance.
Page 42 of 10-Q
Business Model
Our eye business model will utilize a razor/razor blade model. The two sources of revenue: (1) the sale of readers and (2) sale of disposable tests. It is anticipated. that 95+% of gross profits will be generated from the sale of tests. We have not determined the list price of the readers. Discounts will be offered to purchasing groups, corporate accounts, academic institutions engaged in research or training, and others as deemed appropriate. It is anticipated that the average price for the reader will be slightly above our acquisition costs, while pricing of consumable diagnostic kits will be at roughly half of the CMS published reimbursement floor rate. Current pricing is $2,100 for 100 bilateral test cassettes (200 tests) and provides a margin of approximately 65 - 72%.
Market demand for the system is expected to be moderate to begin with until we become a preferred vendor with a large purchasing group or until we are granted a waiver from CLIA. At that time we expect high demand for our system. We also expect high demand for our recently developed MMP-9 quantitative test once we get FDA 510k clearance. While we must compete with other capital equipment expenditures under consideration in any ophthalmic physician?s office, we believe that no other ophthalmic device offers the combination of compelling clinical and financial benefits afforded by our system. The clinical utility of the tests offers important diagnostic precision, differentiation and treatment management direction. Inner-office efficiencies significantly improve the patient flow characteristics, reducing patients in office visit time and greatly reducing physicians chair time with each patient.
Financially, for every patient per day tested the physician will receive, on average, $2 in reimbursement for every $1 expended on supplies.
CMS and private insurance allow for physicians to retest their patients as often as deemed medically necessary. The average retesting rate for Lactoferrin is 65% ,while the IgE retesting rate is 35%.
Dye Eye Disease Competition
Currently there are five FDA approved tests for DED:
(Chart did not cut/Paste correctly. )
The preferred clinical analysis is quantitative, giving us an advantage over the competition. Since our reader can interpret many different analytes other than Lf and IgE, it also opens the possibility of additional quantitative test development.
From Page 41 of 10-Q.
Barry Craig is "CLIA Superman" or "CLIA Captain America".
To manage and navigate the CLIA compliance, readers, lab testing and field-testing process, we have retained veteran laboratory testing executive Barry Craig as a consultant. In this role, he will manage the Company?s DED lab testing initiative. He has more than 25 years of experience in the clinical laboratory as a Generalist, QA Coordinator, and Microbiology Supervisor. He also served as Lab Coordinator for the Children?s Hospital of Alabama for 12 years. Craig has deep-seated experience in regulatory compliance as the owner of Laboratory Consulting, LLC, and has served as the Regulatory Compliance Consultant for CLIA, the Commission on Office Laboratory Accreditation (?COLA?), and the College of American Pathologists (?CAP?). He has successfully established more than 200 moderate and high complexity laboratories, and is a contributor for several trade publications such as MLO magazine, ADVANCE for Administrators of the Laboratory Magazine, and Physician Office Resource Magazine.
From Page 56 of 10-Q.
AXIM will seek a CLIA Waiver.
A CLIA waiver is available to clinical laboratory test systems if they meet certain requirements established by the statute. Waived tests are simple laboratory examinations and procedures employing methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or to pose no reasonable risk of harm to patients if the examinations or procedures are performed incorrectly. These tests are waived from regulatory oversight of the user other than the requirement to follow the manufacturer?s labeling and directions for use. We intend to file a waiver application with the FDA for the Axim Eye System.
From Page 56 of 10-Q.
FDA could require manufacturer to seek a new 510K.
After a device receives 510(k) clearance, any modification to the device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, would require a new 510(k) clearance or an approval of a Premarket Approval, or PMA. A PMA is the FDA process of scientific or regulatory review to evaluate the safety and effectiveness of Class III medical devices which are those devices which support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Although the FDA requires the manufacturer to make the initial determination regarding the effect of a modification to the device that is subject to 510(k) clearance, the FDA can review the manufacturer?s determination at any time and require the manufacturer to seek another 510(k) clearance or an approval of a PMA.
From Page 55 of 10-Q.
Currently AXIM 510K approved tests are Class II tests. Only sites or Laboratories with CLIA certificates can use the tests. AXIM is seeking a waiver from this CLIA requirement.
Unless exempted by regulation, medical devices may not be commercially distributed in the United States until they have been cleared or approved by the FDA. Medical devices are classified into one of the three classes, Class I, II or III, on the basis of the controls necessary to reasonably assure their safety and effectiveness. Class II devices, which our two test for lactoferrin and IgE are classified are subject to general controls, such as labeling, pre-market notification and adherence to good manufacturing practices. Laboratories or sites that perform our tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards.
I prefer to look at it as an EGG seeing how I have real money on this but to each his own.
That Squirrel analyzed this situation pretty well. They diluted substantially between notes and shares. Apparently it was obvious to him that they had no other choice since they were running out of cash due to the new focus on DED and whatever is happening with the neutralizing antibody test. I am guessing that they spent some of the SG&A marketing that test since they severed the relationship with Empowered in late March after a 30 day cure notification.
LT, you still in love with this stock? The lack of volume is a signal of the end....
LT, you still in love with this stock? The lack of volume is a signal of the end....
sold all my traders and most of my core a while back, still hold a little to stay interested and see if this/the squirrel turd ever comes back
i started the shift to much less speculative stuff months back - energy etf, copper etf
also bought some spvnf and other companies WITH REVENUES
Did you take your losses or are you hoping for one last run?
you know this is a complete turd bucket scam, right?
For anyone considering buying AXIM....go buy lottery tickets instead, at least with lottery tickets you gave a chance to make money.
In the short term, (and until we see actual sales) we are basically saying the same thing.
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Unlike currently available serological COVID-19 tests that detect an antibody response to the virus, AXIM’s rapid 10-minute test measures a specific subpopulation of antibodies to block binding of the virus to host cell receptors. While there are expensive, time consuming laboratory tests that measure neutralizing antibodies, NeuCovixTM differs in that it is a portable, low cost, rapid point-of-care test with results in 10 minutes.
“We are hopeful our test fills an important need in these uncertain times. While other tests merely show whether someone was infected with coronavirus, we took it a step further by creating a test that stratifies individuals into those who have neutralizing antibodies, which are essential in preventing reinfection, and those who don’t. The test can be deployed for point of care use in convalescent plasma transfusions to severely ill patients and for evaluating efficacy of upcoming vaccines in generating protective antibodies,” said Sergei Svarovsky, PhD, MBA, AXIM’s CSO and co-inventor of NeuCovixTM.
An immediate application of NeuCovixTM, a point-of-care test, is to measure levels of neutralizing antibodies in convalescent plasma so that plasma with the highest levels of neutralizing antibodies can be identified and administered to patients fighting COVID-19. Without this knowledge, many patients could be undertreated with non-neutralizing plasma and may not benefit from this treatment.
Another application of NeuCovixTM is to help ensure that vaccines elicit high levels of neutralizing antibodies. When a vaccine is available, manufacturers can employ the NeuCovixTM rapid, point-of-care test to evaluate protective immune responses in vaccine recipients.
AXIM® Biotech CEO John W. Huemoeller II commented, “Our goal was to make this test, accurate, fast and relatively inexpensive so it could serve as an ‘Immunity Passport port™’ for vaccine developers around the world as they begin larger Phase II and III clinical trials. We are optimistic that NeuCovixTM will be widely used, becoming the gold standard in assessing levels of immunity.”
Doug Lake, Ph.D. and co-inventor of NeuCovixTM commented, “Everybody who recovers from COVID-19 makes antibodies against the virus, but since all antibodies are not created equal, you really want to know if the antibodies you make neutralize the virus. People who recover want to make sure they are protected from re-infection and that they won’t infect others.”
AXIM also announced the filing of a pre-Emergency Use Authorization Application (EUA) and has already initiated dialogue with the FDA in order to finalize its EUA submission. The intellectual property relating to the novel serological test is the subject of Provisional Patent Application No. 63/023,646 “Convalescent Plasma Testing and Treatment” filed on May 12, 2020.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated oncology company developing rapid diagnostic tests for the early detection of cancer and proprietary small molecules drugs to treat cancer and block metastasis. The Company is also developing novel antibodies for therapeutic and diagnostic uses for oncological therapeutics. For more information, please visit www.AXIMBiotech.com.
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