On Friday, Daxor Announced That Following Discussions With FDA, The Company Has Decided To Withdraw Its Current Dual 510(k)/CLIA-Waiver Application And Resubmit Focused 510(k) Application
Portfolio Pulse from Benzinga Newsdesk
Daxor has decided to withdraw its current dual 510(k)/CLIA-Waiver application after discussions with the FDA and will resubmit a focused 510(k) application.
September 30, 2024 | 11:29 am
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NEGATIVE IMPACT
Daxor has withdrawn its dual 510(k)/CLIA-Waiver application after discussions with the FDA and will resubmit a focused 510(k) application.
The withdrawal of the dual application suggests potential delays or issues with the original submission, which could negatively impact investor sentiment in the short term. However, the decision to resubmit a focused 510(k) application indicates a strategic pivot to address FDA concerns.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 100