Source-linked evidence methodology
ORION is a facts-only scientific research workspace. It does not calculate investment scores, rankings, recommendations, target prices, or expected returns.
1. Identity resolution
Company, ticker, sponsor, asset, brand, and development-code aliases are normalized. A relationship is shown only with its verification state; unresolved identities remain unresolved.
2. Source collection
ClinicalTrials.gov, SEC filings, regulatory records, issuer disclosures, and available market records are collected independently. Each fact retains record identifiers, source links, and retrieval timestamps where available.
3. Claim rendering
Source-backed facts, deterministic calculations, and model-generated synthesis are labeled separately. Unsupported narrative claims are blocked. Conflicting source values are preserved rather than silently reconciled.
4. Coverage and confidence
Coverage describes the presence of evidence across report domains. Relationship confidence describes source-match strength. Neither measure represents investment attractiveness or future performance.
5. Missing data
Missing values are displayed with reason codes and suggested follow-up identifiers. They are never converted to a favorable or unfavorable investment conclusion.
6. Automated release verification
A fixed 25-case cohort is rerun against the same analysis path used by the product. Each run records canonical company, ticker, entity confidence, returned trial count, terminal status, and error code. The release check fails when company attribution or ticker changes unexpectedly, entity confidence drops, a trial count falls below its reviewed floor or by more than half, or a previously working case changes to ENTITY_NOT_FOUND, ENTITY_RESOLUTION_FAILED, or SOURCE_UNAVAILABLE. Baselines are updated only after a reviewed successful run; a live-source outage is reported as an operational failure rather than silently accepted as a new baseline.
7. Known limitations
ClinicalTrials.gov records can name lead sponsors, collaborators, intervention aliases, and legal entities differently. ORION queries sponsor and intervention paths and deduplicates by NCT ID, but registry updates, renamed sponsors, newly added aliases, and upstream availability can still change coverage. Trial count is a coverage diagnostic, not a measure of drug quality or probability of success.
FDA CDER/CBER coverage boundary
Drugs@FDA and Orange Book cover primarily CDER-regulated NDA and ANDA records. Biologics licensed through the BLA pathway, including many antibodies, vaccines, and cell or gene therapies, require separate CBER or Purple Book coverage. Company-level FDA coverage can therefore be lower than the full regulatory record.
Drugs@FDA and Orange Book cover primarily CDER-regulated NDA and ANDA records. Biologics licensed through the BLA pathway, including many antibodies, vaccines, and cell or gene therapies, require separate CBER or Purple Book coverage. Company-level FDA coverage can therefore be lower than the full regulatory record.
Company-level biologics coverage audit ยท 2026-09-03
Three of the 14 audited companies have a structural BLA coverage gap in the current Drugs@FDA and Orange Book workspace. AMGN has 21 BLA records among 27 directly observed applications (77.8%). REGN has nine BLA records among nine observed applications (100%) and no Orange Book connection. MRNA returns no applicant record from the Drugs@FDA query and its previously verified products are handled through the BLA/CBER pathway; it also has no Orange Book connection. These are source-scope limitations, not evidence that no FDA record exists. Companies with a mixture of NDA/ANDA and BLA records remain explicitly partial rather than being described as fully covered.
Three of the 14 audited companies have a structural BLA coverage gap in the current Drugs@FDA and Orange Book workspace. AMGN has 21 BLA records among 27 directly observed applications (77.8%). REGN has nine BLA records among nine observed applications (100%) and no Orange Book connection. MRNA returns no applicant record from the Drugs@FDA query and its previously verified products are handled through the BLA/CBER pathway; it also has no Orange Book connection. These are source-scope limitations, not evidence that no FDA record exists. Companies with a mixture of NDA/ANDA and BLA records remain explicitly partial rather than being described as fully covered.