secwatch.observer — SEC 8-K summary
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Issuer:     DELCATH SYSTEMS, INC. (DCTH)
CIK:        0000872912
Form:       8-K
Filed at:   2023-02-14T23:59:59+00:00
Accession:  0001193125-23-037853
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Delcath resubmits NDA to FDA for HEPZATO Kit in metastatic ocular melanoma
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- NDA resubmission for HEPZATO Kit (melphalan/HDS) to FDA for unresectable hepatic-dominant metastatic ocular melanoma.
- FDA to determine if resubmission is complete response to Sept 2013 CRL within 30 days; if accepted, PDUFA date set.
- FOCUS trial results: ORR 36.3%, CR 7.7%, median DOR 14 months, DCR 73.6%, updated median OS 20.53 months.
- Safety: 41.1% treatment-related serious AEs; no treatment-related deaths.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/872912/000119312523037853/0001193125-23-037853-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/872912/000119312523037853/d455550d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-037853

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer