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This is huge for Verséa Ophthalmics but does not help AXIM at all, at least for now.
86 Pearle Vision clinics to offer Verséa Ophthalmics #Biovance and #Biovance3L products.
It seems Verséa Ophthalmics can create large revenue streams outside their relationship with AXIM.
https://www.linkedin.com/posts/jenniecrabbe_optical-chain-to-exclusively-offer-vers%C3%A9a-activity-7182094188467924992-1SgG?utm_source=share&utm_medium=member_android
Very interesting developments.
New customer was not announced yet by Verséa Ophthalmics.
https://www.linkedin.com/posts/harminchima_we-are-excited-to-offer-state-of-the-art-activity-7181312124533493762-HK5P?utm_source=share&utm_medium=member_android
Wildcards. AXIM has a few.
In my opinion one wildcard is the Parkinsons Disease test. If AXIM sells a new marketing agreement with a big pharma for the Parkinsons disease test that should come with $$ millions in Up-front revenue and residual revenue for each test.
In my opinion that only happens if AXIM needs the Up-front cash = Now. The Up-front cash would be needed because Cash-flow positive is pushed out with only one new customer per week. It should be obvious to everyone that the Tear-based Point-of-Care quantitative Parkinsons disease test would be a great addition to the Verséa Ophthalmics marketing agreement.
The second wildcard is CLIA Waiver approvals. However it seems like Mr Huemoeller mentioned in so many words that the CLIA Waiver Application has not been started yet. AXIM needs help from Verséa Ophthalmics and/or Mr Kurt Phinney to produce the CLIA Waiver Application and the comparison study.
I guess a third wildcard could be a merger or acquisition.
Outside of a few wildcards AXIM is not cashflow positive for months and months. These are my opinions. I really like the potential I see in AXIM. I may increase my position in AXIM in August or later when funds are hopefully available. The stock price probably does not move until AXIM is closer to cashflow positive.
Good luck to all.
Not investment advice.
Don't invest money needed for food or rent or happiness.
They need to to something Tex. They increased the AS on Silver Flume and on a subsequent date updated OTC Markets that there was no change. The 10K really has to address the OS/AS issues. If the AS is really 1Billion Shares it is hard to imagine that they have insufficient shares.
I'm not a good resource for that kind of information.
In my brain, I think about these small Biotech R&D companies in the same way i think about small precious metals Exploration companies.
Management is always trying to raise new money for the next drill program. The big spenders might buy "Preferred Shares" that can be converted later into Common shares. Either way, the Company has to make all of those transactions public knowledge.
Surely AXIM is forced to clear up the Derivative Liability insufficient shares mess by EOY reporting. ( I hope. ).
A question that I have regarding this stock and stocks in general that maybe someone here (Tex?) can address. If a company wishes to dilute by selling into the market or to a private investor to raise some cash where do the shares come from? Do they just need to be available in the AS or do they need to exist in the treasury? If that is the case how do they get there. Does it require a share issuance action like a S1 or is it an administrative action taken on by the company.
That link doesn't work for me but here is one that just worked. I got a log in message when I clicked your link and I don't have a log in account.
https://www.otcmarkets.com/filing/html?id=17417155&guid=11Q-knncHeK-B3h
Well what's it going to be? A 10K-NT at a minute to midnight or a surprise 10K? I'm usually overly optimistic about these things so I'll guess the 10K-NT.
Versea Health hired Stephen Gizzi as a regional sales manager for the New York metro area 5 months ago.
Yesterday Verséa Ophthalmics added a new paying customer from New York. Funny how that works.
Verséa Ophthalmics and Verséa Health are building a sales staff that has added new customers from New York to Seattle. From Cincinnati to Miami. Don't forget about the new customers in Colorado, Oklahoma, Texas, Georgia, and Missouri.
Most of these new sales managers have been in the EyeCare space for many years and already have customers they have built relationships with over the years.
In my opinion, if you want to build a brand new company from the ground up, you probably want to have qualified sales people in all of the major metro areas where your customers live and are doing business. Sure it seems slow right now adding just one customer per week. But just step back and look at where all of these new customers live. Verséa Ophthalmics is adding new customers from every region in the country.
My memory fails me right now.
I don't remember any customers from Los Angeles or Phoenix. A parent company was based in Dallas.
I think AXIM was very successful in choosing Verséa Ophthalmics to sell our Diagnostics tests.
Good luck to all.
Not investment advice.
Don't invest money needed for food or rent or happiness.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Instead of Questions here are a few Answers.
AXIM insiders and friendly parties have complete control of the company. Good, Bad or Ugly.
Catalina Valencia has been Legal Counsel for another startup company named Genentech Inc.
We have been told in the past that
Verséa Health and Verséa Ophthalmics are investors in AXIM. If the rights to the Tear-based Point-of-Care Parkinsons disease test are sold or subject to a negotiated marketing agreement to a Big Pharma then Verséa as part owners in AXIM will still benefit. Maybe Verséa does not have enough time or money to commit to the Tear-based Point-of-Care Parkinson Disease test.
More questions than answers - Continued.
As a Tear-based Point-of-Care (TPOC) Parkinson Disease test it seems a perfect fit with our existing Merchandising partner Verséa Ophthalmics. Right?
Are the $$ dollarss from one or more Big Pharma companies too big for Verséa Ophthalmics to even bid on this test?
Is it rock solid interest?
Is it backed up by $$Millions in a down payment AND residual $ dollars to AXIM for each test?
Something is going on that we can't see right now. More questions than answers.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Another paying customer has been added.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitan-tpoc-ded-activity-7179130900289351680-VhAU?utm_source=share&utm_medium=member_android
Website from new customer.
Manhattan New York apparently.
https://www.eyewise.com/our-eye-doctors/
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Exactly. Very confusing to not lead off with the revenue generating product that is already FDA cleared, and is being manufactured by an ISO-13485 certified manufacturer and is being marketed by a very knowledgeable team at Verséa Ophthalmics. Very interesting.
However the video does make me think that the Parkinsons disease test must be generating a lot of interest from one or more Big Pharma companies. Since it is a Tear-based Point-of-Care quantitative Diagnostics test one would think it would play well in the EyeCare space.
Is it rock solid interest?
Is it backed up by $$Millions in a down payment AND residual $ dollars to AXIM for each test?
More questions than answers.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Put your best foot forward?…raises eye rubbing questions.
We try not to give investment advice about AXIM. Probably most people who post here on the AXIM IHUB board have been invested in AXIM since the Covid days.
AXIM is generating revenue right now. Revenue seems to be growing every month. Apparently the CLIA Waiver Applications for the existing tests have not been submitted to the FDA yet. There is some type of process that needs to be followed to fill out the Waiver Application and also comparison studies with tests that are already have Approved CLIA Waivers. It is not a "simple" process. Is sounds like AXIM has not even started the process.
What does this mean for the business?
AXIM will have revenue grow at a slow pace until CLIA Waivers are submitted and approved.
AND/OR
AXIM could use the potential for a "Blockbuster" Parkinsons disease Tear based Point-of-Care test to generate both Up-front and residual revenue by signing a Marketing agreement with a large Pharma that can take the full responsibility of walking the test through the FDA process with the agreement that AXIM would still receive a fixed amount per test after it goes to market. That could happen.
A lot of things could happen over the next few months. Interesting times for AXIM right now.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
The recent note creates 81.5 M shares years in the future. What I want to see is the conversion of the variable notes marking management's assessment that the stock has bottomed. Those have to be converted soon if the stock is indeed bottoming. It is of course a good sign that management accepted a new note in lieu of salary convertible into shares at 1 and 2 cents but my big indicator will be when the old variable conversion (TOXIC) notes convert. I have been avoiding using that word but since Tex used it I will too!
Blue Skys you were right about all of the Form 4’s AXIM would release
In the interview CEO JH said that he surmised that the FDA did not want patients and doctors to see precisely with the test that their antibody levels for Covid drop fast after the vaccine administrations. I thought that was interesting to hear about.
The stock price was 80 cents to $1.00 a few years ago when stockholders were hoping for the roll out of the Covid antibody level tests. We are now at a low of 1 cent for a few trades today.
He said that our dry eye disease tests are worth around 10X our current market cap. That does not include the Parkinson’s Disease test which seems like to me it would have a large market. There are likely other interesting tests that Sapphire is researching.
He mentioned the CLIA Waiver time for approval at the FDA is now targeted for 90 days and not the previous 8 or 9 months. That is good to hear about.
The stock chart shows a very dim prospect for this company but in actuality there are good reasons in my view to foresee and hope for a reasonable chance of success with AXIM.
Is it naive for me to feel this way? Maybe someone should describe here the probable likelihood of the reverse split risk in the near future. Then there are the subsequent offerings dilution risks.
There are other sometimes overlooked pitfalls of buying pre revenue small cap biotech companies. The tactics of shorts and toxic convertible debt schemes are also considerations.
Thanks.
From Yahoo
https://finance.yahoo.com/news/video-axim-biotechnologies-ceo-presents-130000171.html
Company CEO John Huemoeller II Interviewed by Tony Noto on AXIM’s Diagnostic Research Programs in Dry Eye Disease and Parkinson’s SAN DIEGO, CA, March 27, 2024...
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Link to the Benzinga 2024 Virtual Healthcare Summit 2024. AXIM has a prominent placement on this Website. Mr Huemoeller is advertising AXIM.
https://www.benzinga.com/events/virtual-healthcare-summit-2024/
If the #Parkinsons #TPOC #Diagnostics test is being used as leverage and as advertising to attract future financial relationships I have to think the Auer Precision relationship has created a prototype test that can be demonstrated in front of these potential relationships. Auer Precision advertises their R&D to help companies create real prototype examples to help speed products to market.
Have a good day!
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Verséa Ophthalmics is in Boston at booth # 346 APR 05-08, 2024
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_ascrs2024-asoa2024-versaezaophthalmics-activity-7178722469820665856-7Bz2?utm_source=share&utm_medium=member_android
Link to ASCRS website
Celebrate the 50th anniversary of ASCRS alongside the premier clinical education and networking opportunities at the ASCRS Annual Meeting.
Be inspired by history and part of defining the future at the 2024 ASCRS Annual Meeting.
https://ascrs.org/annual-meeting
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons #TPOC #Diagnostics
#Lactoferrin #510K
510(k) Number K934473
#TotalIgE #510K
510(k) Number. K991316
Just a question. Is the delay on the CLIA Waiver Application process also being used as leverage?
Parkinsons disease test being used as leverage.
Is CLIA waiver delay being used as leverage?
I can't imagine AXIM wants to sell away control of their company right here at the beginning.
Does AXIM have enough leverage with the Parkinsons disease test to consolidate Verséa Ophthalmics into the next reality?
What will happen over the next few months?
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons Diagnostics
510(k) Number K934473
#510K #Lactoferrin
510(k) Number. K991316
#510K #TotalIgE
After watching the new video a few times it is obvious. The Parkinsons Disease test is being used as leverage to bring about the next reality for AXIM.
The Parkinsons disease test was mentioned first and consumed maybe the first 4 or 5 minutes of the video. The Parkinsons disease test was the last thing mentioned in the video with banter about discussions with larger companies and revelations and the SEC.
The video did not lead off with the two FDA cleared Dry Eye Disease tests and the 50000 eye doctor locations in the US as potential customers for their tests being manufactured and sold into the market right now. The video led off with the Parkinsons disease test.
I find that interesting.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Parkinsons Diagnostics
510(k) Number K934473
#510K #Lactoferrin
510(k) Number. K991316
#510K #TotalIgE
When JH mails the investor letter that was promised to be sent late August 2023 and/or updates the AS on OTC markets to match the AS on the Nevada SOS website and provides detail of the OS increase investors will have a picture that they can analyze. Will that detail be provided in the pending 10K or will it only be partially disclosed with just the AS increase, with the note conversion still behind the veil of the Derivative Liability Insufficient Shares entry? It's impossible to analyze the financial statements even if there was a revenue forecast since the OS as disclosed is effectively unknown. It is true that the company has a pipeline that seems to have made its way to the faucet but it also seems that a great deal of effort has been made to conceal the effective share count and convertible note status by using perfectly legal FASB approved accounting practices.
The March 9 update on OTC markets is puzzling because the Transfer Agent showed an increase in the OS but did not account for the AS increase and it is not clear at least to me what constituted the 38,280,000 OS increase. Was that dilution for cash, shares for the companies partners, variable note conversions (partial)? In a period of minimal OS disclosure there must have been an event related to the OS that the company felt needed to be disclosed to persuade them to post it to OTC Markets.
Authorized Shares
300,000,000 03/09/2024
Outstanding Shares
275,929,403 03/09/2024
Restricted
157,711,651 03/09/2024
Unrestricted
118,217,752 03/09/2024
Thanks for posting that pointer. JH has slowly become more relaxed and confident in these interviews as the business progresses and the years pass. I recall one a long ways back that really had me worried. It almost seems like he is channeling another guy who had his company go live on the Nasdaq today with great results. It looks like he may have the same hair stylist and could be wearing a tinge of orange makeup.
Thanks for sharing!
Video seems to be about 4 days old. It must have been posted Thursday or Friday.
https://aximbiotech.com/investors/
Axim updated website investor page with interview with Benzinga... Great update!
Benzinga Virtual Healthcare Summit
Waiver has not been applied for from this update with the indication that timeline on approval can be 90 days once applied.
You may have misunderstood my point.
My post was not to cast doubt about anyone's character or professionalism. Actually the opposite is true. Jessica Barr is the only constant in every TPOCTITAN post. Jessica Barr is on location for every go-live. Her frequent flyer miles are stacking up these last 12 weeks.
My only point is that humans need a break or vacation every now and then. If you zoom in on the TPOC announcement pictures, you will see only two names from Verséa Ophthalmics on the official document stating that a location passed the CLIA lab requirements and can start selling the TPOC tests.
Dr Robert Sambursky is one name.
Jessica Barr is the second name.
There is a third name, but I think that is reserved for the local doctor to sign.
There has not been a New Customer announcement in almost 2 weeks. Maybe there is a simple reason for this gap. If Jessica has not had a break in 12 weeks, maybe she needed a few days off. That is the only point I was trying to make. Maybe she has a family. Maybe she and the kids needed a spring vacation.
I don't know anything about her life other than the large responsibility she has to certify a doctor's office that they are approved to use and sell the TPOC tests.
It may be that the 50 locations signed up by the July 2023 AXIM Press release evaporated with the delay in manufacturing product. Did Verséa Ophthalmics have to start from scratch in December 2023?
Not a new customer announcement. This post is a celebration of their existing #TPOCTITAN family.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_tpoctitans-tpoc-ophthalmics-activity-7178360665693200384-i20m?utm_source=share&utm_medium=member_android
I'm just thinking out loud. I wonder if Jessica Barr needed a spring break? Small growing businesses depend on individual people in outsized ways.. People are not robots. Stated another way - small growing businesses can sometimes have a single point of failure.
Just a guess.
Maybe I'm just over thinking.
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
510(k) Number K934473
#510K #Lactoferrin
510(k) Number. K991316
#510K #TotalIgE
It almost "feels like" Mr Huemoeller and AXIM management are letting Verséa Ophthalmics tell the whole story about our products.
If I knew anything about charts (and I don't) the AXIM charts don't tell me anything about the recent sales. Daily charts: Not much but we do have higher volume over the last month. However the volume is similar to higher volume in the month of March in past years. Nothing stands out yet. Weekly charts? Monthly charts? Nothing. Just a downhill ski-slope. Maybe word of mouth travels slower on OTC? The recent volume might suggest we have a few more eyeballs, but not many. The dollar amount behind the volume is still a very small amount.
AXIM is still spending way too much money compared to sales revenue. Verséa Ophthalmics as well. Even with all of the recent sales activity it might still be possible for failure if sales don't materialize fast enough. Both companies are spending way too much money. Both companies desperately need CLIA waiver approvals NOW. Or last month or last year.
As for me, I have more AXIM shares right now than I ever thought possible a couple years ago. However my new money is chasing other things right now. I'm hoping to catch lightning in a bottle somewhere else for the next 4 or 5 months so l can decide in August 2024 if I want a lot bigger position in AXIM. That's my plan. Things could change. But if we only get one new customer per week it will take a long time for AXIM to be cash-flow positive.
Not investment advice.
Do your own research.
Don't invest money needed for food or rent or happiness.
Its surprising that with so many new customers there are very few views on the youtube channel. Basicly the old view counts. I wonder why that channel is not being utilized more.
No new customer announcements this week.
Average is about one customer per week over last 12 weeks. Cash-flow positive is many weeks away at this pace.
Two other posts this week.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_optometry-thankyou-verseaophthalmics-activity-7177242705847033856-egyO?utm_source=share&utm_medium=member_android
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
510(k) Number K934473
#510K #Lactoferrin
510(k) Number. K991316
#510K #TotalIgE
ASCRS/ASOA 2024 Annual Meeting.
Boston. Booth # 346.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_ascrs2024-asoa2024-versaezaophthalmics-activity-7176185747341758467-Uvop?utm_source=share&utm_medium=member_android
Hashtags related to our company and partners.
Merchandising partner:
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
Manufacturing Partner:
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
510(k) Number K934473
#510K #Lactoferrin
510(k) Number. K991316
#510K #TotalIgE
100% on all points! I am still watching and this COULD be a great ticker IF they get CLIA waiver and start selling lots of tests
It is too easy to fall down a rabbit hole trying to research the FDA for information when all we need is for AXIM Management to tell us in clear language what the status is for CLIA Waiver Applications/Submissions/Approvals.
When I dig down into these Substantially Equivalent comparisons I come away with more questions than answers.
AXIM has in fact modified these tests from the originals. The modifications have been beneficial. Faster more accurate results. Added a reader. Fewer tears.
Obviously AXIM and Verséa Ophthalmics can sell these tests as per the original FDA 510K.
The best policy with AXIM is to not assume anything. If AXIM management did not tell you something then it didn't happen. When I opened my eyes and stopped assuming things about AXIM it was much easier to make decisions.
In my opinion the CLIA Waiver Application process had to start over in December with the announcement of Auer Precision as manufacturing partner.
In my opinion if AXIM did not tell you that CLIA Waiver Applications have been submitted to the FDA then they probably have not been submitted. Don't assume anything unless AXIM told you. In a press release or in a 10-Q or some other form.
Verséa Ophthalmics is signing up paying customers as CLIA compliant labs. That is all we know right now.
Good luck.
Not investment advice.
I believe that even though the Lactoferrin test appears to have been updated as a Class 1 test, possibly on December 22nd, 2023, it seems that AXIM still has the requirement to go through the CoW process (Certificate of Waiver).
Cut/Pasted from the FDA CLIA Waiver Application website.
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application
A manufacturer of a test initially categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to the FDA. When a test is categorized as waived, it allows that test to be performed by laboratories with a Certificate of Waiver (CoW) or a Certificate for Provider Performed Microscopy (PPM) in addition to the other CLIA Certificate types. In a CW submission, the manufacturer provides evidence to the FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3). The statute states that:
"The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver] are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that — (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly."
If the Lactoferrin test is a Class 1 test then by definition the Lactoferrin test is a CLIA Waived test. Why has AXIM Management not told us this???
Is there any benefit in having one Class 1 test and the other a Class 2 test?
There should be great benefit.
First and foremost ALL of our potential customers should be able to order the Lactoferrin Tests and become familiar with the test reader. Then already be familiar with the TPOC system once the IgE test is Waived.
NOTE: I believe the IgE test is currently stuck inside an FDA division where ALL tests are classified as Class 2. That could be a problem except our test is a Tear-based Point-of-Care test.
510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473
===============================
510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316
===============================
Our IgE test is "Substantially Equivalent (SESE) to other IgE tests that fall under the Class 2 designation. Some IgE diagnostic devices test blood samples. Our device tests tear drops.
It appears all IgE tests fall under the.
Division of Immunology and Hematology Devices (DIHD) and seems all are coded as Class 2.
There is an Ophthalmics division under DIHD.
TPLC - Total Product Life Cycle
Device : Ige, Antigen, Antiserum, Control
Product Code DGC
Regulation Number 866.5510
Device Class 2
Substantially Equivalent (SESE)
HOWEVER. I believe our Lactoferrin test has already been updated as a Class-1 (Waived) test as of December 22, 2023. If I am reading correctly.
Our Lactoferrin test may be a Class 1 test since December 22nd, 2023. (Class 1 = Waived)
Replying to a previous post where I provided links to FDA database for our 510K tests.
Pages to both tests show they were updated December 22nd, 2023.
The link to the Lactoferrin Test seems to indicate a Class 1 test.
Click on the Lactoferrin link.
Click on the link to section Sec. 866.5570
Lactoferrin immunological test system.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
The IgE test still appears to be a Class 2 test, but that page was last updated on 03-11-2024.
Searching on new information for IgE now.
510(k) Number K934473
Device Name
LACTOFERRIN MICROASSAY SYSTEM
Date Received 09/14/1993
Decision Date 12/03/1993
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K934473
===============================
510(k) Number. K991316
Device Name
TOUCH TEAR IGE MICROASSAY KIT
Date Received 04/19/1999
Decision Date 08/09/1999
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K991316
===============================
Applicant
TOUCH SCIENTIFIC, INC.
3209 GRESHAM LAKE RD.
SUITE 112
RALEIGH, NC 27615
FDA CLIA waiver guidelines. Review takes anywhere from 90 days to 320 days.. There is a FastTrack path for 510K/CLIA-WAIVER applications submitted together. 180 days.
Enjoy
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application
Additionally Auer Precision is ISO-13485 certified.
Cut/Paste from link on page that opens a pdf:
"Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff "(PDF - 124KB)
A test initially categorized as moderately complex might meet the statutory criteria for CLIA
waiver if the device is simple to use and the sponsor demonstrates in studies conducted at the
intended use sites that the test is accurate and poses an insignificant risk of erroneous results. If a
Sponsor of a test categorized as moderate complexity believes their test meets the statutory
criteria for CLIA waiver, they may submit a CLIA Waiver by Application to request
categorization of the test system as waived. Such a submission should be mailed to the CDRH
Document Control Center (DCC) at the address listed above and identified as a CLIA Waiver by
Application submission. Note that all such submissions should be directed to CDRH, regardless
of the FDA Center responsible for the marketing review. To expedite review, FDA strongly
encourages submission of a validated eCopy per the Guidance Document “eCopy Program for
Medical Device Submissions.”
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocu
ments/UCM313794.pdf ).
CLIA Waivers by Application should reference a cleared/approved marketing application (e.g.,
510(k), PMA, BLA). As described in the MDUFA III and MDUFA IV Commitment Letters, an
applicant should inform FDA that it plans to submit a Dual 510(k) and CLIA Waiver application
Lol. Right!!! My guess is the clock was restarted AFTER the December 20th announcement about Auer Precision becomming the Merchandising partner for AXIM.
Besides Dr Sambursky has done this before. Once all the ducks got lined up on December 20th my guess is the paperwork was submitted after that. Maybe in January.
I don't think anyone benefits with an extended delay. Not AXIM. Not Verséa. Not Shareholders.
The FDA website is very busy with activity. This should not take long once the paperwork is complete.
CLIA Waiver is taking longer than a Spaceship to Mars. Trial that takes 3 weeks to do. Either the FDA or AXIM has a problem. AXIM has no reason for the delay unless they left out some important facts in their story. We know John would never do that. LoL
I think now is a great time to buy.
On the other hand.
Unless we hear about CLIA Waiver approvals or some type of unexpected merger with Verséa or something else as big News as that, it looks like it takes awhile for AXIM to become cash-flow positive.
We have to start picking up more than one customer per week at some point.
It seems like Jessica Barr is the lonely road warrior for Verséa Ophthalmics. Obvoiusly she must be flying back and forth across the United States instead of being a road warrior but I digress.
Even AFTER CLIA Waiver approvals Verséa Ophthalmics has to ramp up their sales staff to ensure every location is trained correctly.
I do expect the growth story to become a really big deal at some point. But it feels like retail investors are still pushing this band wagon for months into the future.
Not investment advice.
Don't invest money needed for food or rent.
Have a great day!!!
First customer from the Pacific Northwest announced today on LinkedIn.
https://www.linkedin.com/posts/vers%C3%A9a-ophthalmics_welcome-pacific-clear-vision-institute-to-activity-7173764956067115009-3gn7?utm_source=share&utm_medium=member_android
Hashtags related to our company and partners.
#VerséaOphthalmics
#VerséaHealth
#TPOC Tear based Point-of-Care
#DryEye #Diagnostics #Quantitative
#Lactoferrin #TotalIgE
#TPOCTITAN #TPOCTITANS
#AuerPrecision ISO Certified
#ISO9001 #ISO13485
#AXIMBIOTECH
#AXIMEYE #DryEye
#Lactoferrin
#TotalIgE
Just like the last dip. Always a big purchase transaction. 3M share day today so far. I have trouble understanding it but when you read people who follow it closely like Tex's posts it seems like some people are worried.
Someone is crazier than me 1.414,300 Buy order
Call me Crazy Bought another 78000
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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