Further sentiment from the recent 10Q: "Developme
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Posted On: 04/14/2024 6:36:30 AM
Further sentiment from the recent 10Q:
"Developments
During 2022 and 2023, the Company worked to address certain deficiencies in its Premarket Approval (PMA) application that were identified by
the FDA in 2021. These were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products. As of the date of this report we have implemented procedures and Good Manufacturing Practices that are responsive to the deficiencies identified by the FDA.
On March 21, 2024, we submitted to the FDA a revised Premarket Approval application to market our absorbable hemostatic gauze for human
surgical applications in the United States. The FDA is currently reviewing our application and there can be no assurance that our PMA application will be
approved."
"Developments
During 2022 and 2023, the Company worked to address certain deficiencies in its Premarket Approval (PMA) application that were identified by
the FDA in 2021. These were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products. As of the date of this report we have implemented procedures and Good Manufacturing Practices that are responsive to the deficiencies identified by the FDA.
On March 21, 2024, we submitted to the FDA a revised Premarket Approval application to market our absorbable hemostatic gauze for human
surgical applications in the United States. The FDA is currently reviewing our application and there can be no assurance that our PMA application will be
approved."
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