Mainz BioMed NV (MYNZ) Quote

Last uptick?

MYNZ new 52 week low

Looks bad. No touch

Any news on this? FDA decision?

Waiting for news. Financials and fda response anyday imo

Is this stock losing traction? Where is the FDA approval?

Appears they got the FDA approval because the bleeding of the last few days has reversed. JMO

Obviously there will be a buyout with the FDA approval and a big run up. They always drive the pps down right before the run up to buy as cheap possible. Always some sort of manipulation going on. JMHO.

Obviously there will be a buyout with the FDA approval and a big run up. They always drive the pps down right before the run up to buy as cheap possible. Always some sort of manipulation going on. JMHO.

Dunno,shorts tearing into it today like a monkey eating a cupcake,shares to short went way up

Will the FDA approve?

Will be interesting AH
Approval or Not

Ready

Charting up,FDA news expected,

Bring on the fda news!

Little Fomo

Will the FDA approve…?

Chart lines soon crossing

MYNZ...39s clearing here...Off my .44 Alert...🥳

georgie18

Member Level
Re: georgie18 post# 655296

Monday, August 26, 2024 4:42:19 PM

Post#
655298
of 655457
MYNZ...44...on the 50MA Break...🥳

Loading zone, IMO .

Waiting on FDA decision

Not in a hurry !

Apparently no. Lol

Can we see so 50s today !

MYNZ...44...on the 50MA Break...🥳

45s looks like breakout on the way !

You welcome, still waiting on volume, I think after hours should be interesting, GL .

Ok thanks

🔍 $MYNZ ’s ColoAlert test could set a new standard in cancer screening. Analysts target $1.50, but buzz is $5-$10 per share. Just loaded up! $EXAS $NVTA $GH #CancerDetection #HealthTech #Biotech #BuyTheDip #ToTheMoon #BuyTheDip #ToTheMoon $COIN $NFLX $ATVI #CamperXBecky pic.twitter.com/DDCBCdmeMI— Michael Johnson (@HenryV64655) August 26, 2024

Nice outlook

have you heard any projections on share price if the FDA approves?

42s up

Volume in !

Creeping up !

I’m not sure if that’s good or bad, maybe people loading, waiting on news, the last PR was about a month ago, and it’s moving on Friday, that’s what got my attention, hopefully we will get some news next week, it’s about time, IMO .

Quiet board

Coming off the 52WL, let’s see if we can get some attention, in for now !

Invest at your own risk!!!


https://stocktwits.com/BreakoutMaster8/message/583420341

MYNZ new 52 week low

$MYNZ is about to explode! Just saw an alert: #FDA submission is done, and they’re targeting massive partnerships! 🚀📷 #DiamondHands #BuyTheDip #HBDSurBeryliyaciaga #BalenciagaxMilk $AAPL $GME #8YearsWithBLACKPINK #internationalcatday $AMC $AMZN #Biden #ToTheMoon #YOLO pic.twitter.com/VpWDEA9utO— Julia Thompson (@ouma15) August 8, 2024

https://www.rttnews.com/3458713/mainz-biomed-seeks-fda-breakthrough-status-for-next-generation-crc-screening-test.aspx

This board is very quiet

https://finance.yahoo.com/quote/MYNZ/

https://mainzbiomed.com/mainz-biomed-announces-submission-for-fda-breakthrough-device-designation-for-its-next-generation-crc-screening-test/

Is there a projected target price on this?

MYNZ......................https://stockcharts.com/h-sc/ui?s=MYNZ&p=W&b=5&g=0&id=p86431144783

submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.
The regulatory submission follows consistently excellent read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO 2024. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the Company plans to use in its Next Generation product, and the FDA premarket approval study.

The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.

Key Findings

Sensitivity for Colorectal Cancer: 97% (95% confidence interval: 83.3-99.9)
Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence interval: 77.2-94.5)
Specificity: 93% (95% confidence interval: 88.4-98.3)
Guido Baechler, Chief Executive Officer at Mainz Biomed, commented, “On the back of our extremely positive clinical results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our Company. Our Next Generation Test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and specificity for CRC. Moreover, we believe that our unique decentralized model of working with third party laboratory partners provides better access to underserved communities and our simple collection process will increase the adherence to testing. These benefits support our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”

The FDA’s Breakthrough Devices Designation is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to allow patients and health care providers timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ or subscribe to our news alert to keep up to date on our pivotal FDA PMA clinical trial ReconAAsense and further corporate news.

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About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market oppo

MYNZ .68 + 40%

MYNZ new 52 week low

MYNZ new 52+ low