CO-DIAGNOSTICS DL-,001 WKN: A2DU6V ISIN: US1897631057 Kürzel: CODX Forum: Aktien Thema: Hauptdiskussion

The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test's performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform. The Company's primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others. *The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.

SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process.

Sag mal bist du mit dem Egon verwandt?

Alle die auf lana stehen dürfen sich gleich freuen ☝🏻

Pumpt gut nach oben

0,428 €

- 10,18 % bereits im Premarket Läuft und einen lieben Dank an MariaBlaum für den professionellen Tip im Beyond Meat Forum...

Das Einzige, was Ihr hier noch braucht sind Zocker, die das Teil vielleicht hochtreiben, aber die waren ja schon da. Von der Firma brauchst Du nichts erwarten.

Wir brauchen viel mehr Volumen dann kann man auch mit dem Spread was anfangen

Ich glaube die werden heute nicht viel machen

Mal schauen was die Amis gleich machen

*raus und

So betrachtet müssten wir eigentlich nach dem nächsten Push rausznd nach der nächsten KE wieder rein

Pro quartal vernichten sie 7 Mio $. Bedeutet die eingenommenen 7 Mio $ sichern die nächsten 3 Monate ab. Bedeutet, für eine erneute KE in 3 Monaten müssen sie wieder den Kurs pushen 😎

Aber vielleicht hauen sie eine News raus wegen dem Saudi Deal

Dann kauf ich groß nach