GENinCode has announced the filing of a pre-submission for its Cardio inCode-SCORE test with the US FDA, as recommended by the agency. A pre-submission provides a structured framework for discussion of the future marketing application between the FDA and the device manufacturer. Essentially, we see this as an opportunity for the FDA to review the submission ahead of an ‘official' filing to ensure that the future application will answer all the questions the FDA requires to be addressed. The pre- ....
11 Jan 2022
Cenkos: GENinCode Plc -- FDA Pre-Submission filed
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Cenkos: GENinCode Plc -- FDA Pre-Submission filed
GENinCode PLC (GENI:LON) | 6.9 0 0.0% | Mkt Cap: 12.2m
- Published:
11 Jan 2022 -
Author:
Chris Donnellan -
Pages:
5
GENinCode has announced the filing of a pre-submission for its Cardio inCode-SCORE test with the US FDA, as recommended by the agency. A pre-submission provides a structured framework for discussion of the future marketing application between the FDA and the device manufacturer. Essentially, we see this as an opportunity for the FDA to review the submission ahead of an ‘official' filing to ensure that the future application will answer all the questions the FDA requires to be addressed. The pre- ....