SEC Filing Summary: AspenBio Pharma, Inc.
Business Context and Reporting Period
This Form 8-K was filed by AspenBio Pharma, Inc. on June 30, 2009. The registrant is incorporated in Colorado and operates from Castle Rock, CO. The filing reports a specific corporate event rather than periodic financial results.
Key Financial Metrics
The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on a regulatory filing event and does not contain financial statements.
Material Changes and Events
- Regulatory Filing: On June 30, 2009, AspenBio Pharma filed a 510(k) notification with the U.S. Food and Drug Administration (FDA).
- Product: The notification pertains to the AppyScore test.
- Significance: A 510(k) submission is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed device (predicate device) already in the U.S. market.
Guidance, Outlook, and Risks
The filing does not contain management guidance, financial outlook, or a discussion of risks and contingencies. The document serves solely to disclose the submission of the 510(k) notification as an "Other Event" under Item 8.01.
Investor Verification Checklist
- Verify the status of the AppyScore test 510(k) submission with the FDA.
- Confirm the timeline for FDA review and potential approval dates.
- Review the attached press release (Exhibit 99.1) for specific details on the AppyScore test's intended use and market potential.
- Check subsequent filings for updates on the regulatory decision.