Risk Factors Update Summary
- Drug development is highly speculative; never generated revenue from sales; need substantial funding.
- FDA and regulatory changes may delay approvals, increase compliance costs, and affect regulatory submissions.
- Delayed filing of IND application due to supply chain constraints and staffing issues.
- Concerns about patient enrollment in clinical trials due to various disruptions and challenges.
- Potential impact of legislative changes on profitability and commercial success.
- Uncertainty regarding orphan drug exclusivity scope and impact on future approvals.
- Increased volatility in capital markets due to ongoing armed conflicts, affecting global economic consequences.
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=1496323&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.