Source ID: D04
Original URL: https://www.merck.com/news/patritumab-deruxtecan-bla-submission-receives-complete-response-letter-from-fda-due-to-inspection-findings-at-third-party-manufacturer/
Title (supplied): Patritumab Deruxtecan BLA Receives Complete Response Letter Due to Third-Party Manufacturer Inspection
Source date (retained): 2024-06-26
Data date (retained): 2024-06-26
Checked at: 2026-10-07T18:42:41+08:00
Timezone: Asia/Taipei
Checked-at meaning: current review of returned public web-tool extraction; not the historical network-fetch timestamp.
Retrieval mode: public_web_tool_readback_prior_ref; prior saved web_ref was opened and returned the specified original public URL.
Prior web ref: turn35view5
Current web ref: turn110view0
Read level: relevant primary-source paragraphs in web text extraction; complete original HTML/PDF bytes not saved or hashed.
Original network read time: null; not exposed by the tool. Original artifact SHA256: null.
Locator: Company announcement opening; retrieved lines 94–110, especially 104–105.
Minimum verbatim excerpts (aggregate <=25 English words):
- inspection of a third-party manufacturing facility
- efficacy or safety
Excerpt word count: 9
Factual extraction (values, dates, statuses; not additional prose quotations):
[
  {
    "field": "announcement_date",
    "original_value": "June 26, 2024",
    "unit_or_role": "calendar date",
    "locator": "L94"
  },
  {
    "field": "CRL_basis",
    "original_value": "third-party manufacturing inspection",
    "unit_or_role": "company-reported status",
    "locator": "L104"
  },
  {
    "field": "submitted_efficacy_safety_issues",
    "original_value": "none identified in the CRL, according to the companies",
    "unit_or_role": "company-reported status",
    "locator": "L105"
  }
]
Support scope: Company reported a June 2024 HER3-DXd CRL arising from third-party manufacturing inspection findings and reported no efficacy/safety-data issues. This is the company’s account, not an FDA CRL.
Precise gap: No additional source-specific factual gap found within the assigned contribution; multi-source rows retain their other citations.
Source/data dates are supplied baseline metadata, not replaced by this check time. No alternate route, login, headers, private endpoint or payment used.
This small evidence record is an excerpt/factual extraction, not a saved full article.