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

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Trading989
Trading989, 29. Okt 13:26 Uhr
0
Lässt euch nicht abmaulen 😊
AMK2020
AMK2020, 29. Okt 13:25 Uhr
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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that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k)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.

Astraman25, 29. Okt 12:59 Uhr
Hab das Gefühl das du schön.lana genommen wurdest
Trading989
Trading989, 29. Okt 13:25 Uhr
0
Zieh an du alte Sau
A
Astraman25, 29. Okt 13:00 Uhr
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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.
A
Astraman25, 29. Okt 12:59 Uhr
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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.
AMK2020
AMK2020, 29. Okt 12:57 Uhr
0

Pumpt gut nach oben

Trading989, 29. Okt 12:50 Uhr
Sag mal bist du mit dem Egon verwandt?
AMK2020
AMK2020, 29. Okt 12:56 Uhr
0
Alle die auf lana stehen dürfen sich gleich freuen ☝🏻
Trading989
Trading989, 29. Okt 12:50 Uhr
0
Pumpt gut nach oben
dynamic
dynamic, 29. Okt 12:43 Uhr
0
0,428 €
dynamic
dynamic, 29. Okt 12:41 Uhr
1

Mal schauen was die Amis gleich machen

Trading989, 29. Okt 12:20 Uhr
- 10,18 % bereits im Premarket Läuft und einen lieben Dank an MariaBlaum für den professionellen Tip im Beyond Meat Forum...
R
Radler72, 29. Okt 12:34 Uhr
1

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

Astraman25, 29. Okt 12:26 Uhr
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.
A
Astraman25, 29. Okt 12:26 Uhr
0
Wir brauchen viel mehr Volumen dann kann man auch mit dem Spread was anfangen
A
Astraman25, 29. Okt 12:25 Uhr
0
Ich glaube die werden heute nicht viel machen
Trading989
Trading989, 29. Okt 12:20 Uhr
0
Mal schauen was die Amis gleich machen
A
Astraman25, 29. Okt 12:19 Uhr
0
*raus und
A
Astraman25, 29. Okt 12:18 Uhr
0
So betrachtet müssten wir eigentlich nach dem nächsten Push rausznd nach der nächsten KE wieder rein
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