Daxor Corporation Streamlines Regulatory Strategy for Groundbreaking Diagnostic Device [Yahoo! Finance]
Daxor Corporation - Closed End Fund (DXR)
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Source: Yahoo! Finance
This decision comes after considerable progress in addressing key regulatory considerations and aims to expedite the approval process, potentially bringing this innovative technology to patients sooner. "We're excited about the positive momentum in our discussions with the FDA," said Daxor CEO and President, Michael Feldschuh. "Our team has made substantial strides in resolving critical issues, and this strategic shift allows us to capitalize on that progress. By focusing on the 510(k) pathway, we're streamlining our approach and potentially accelerating our time-to-market." The company's decision to transition to a simple 510(k) application is based on several factors: Significant progress in addressing key regulatory requirements Identification of a small set of additional technical data needed for approval Opportunity to expedite the approval process by focusing on 510(k) clearance Daxor plans to pursue a separate CLIA-waiver application subsequently, allowing for a mo
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DXR
Analyst Actions
- 9/9/24 - Ascendiant Capital
DXR
Sec Filings
- 11/21/24 - Form NPORT-P
- 9/10/24 - Form N-PX
- 8/29/24 - Form NPORT-P
- DXR's page on the SEC website