Risk Factors Update Summary
- Violations of Anti-Kickback Statute could result in criminal fines, civil penalties, and exclusion from federal health programs.
- Failure to comply with CLIA requirements may impact marketing approval for diagnostic product candidates.
- Failure to meet regulatory quality standards could lead to ceasing manufacturing operations.
- Failure to comply with federal, state, and international regulations may lead to financial liabilities.
- Potential impairment charges may occur if diagnostics segment and Ireland unit underperform.
- Directors, officers, and stockholders own a significant percentage of outstanding voting securities.
- Failure to obtain regulatory approvals for international operations could adversely affect future results.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=944809&owner=exclude
This content requires a 'Free' membership to view. Please create one here.
This content requires a 'Free' membership to view. Please create one here.