secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2023-10-24T23:59:59+00:00
Accession:  0001104659-23-111088
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone files NDA for etripamil; Phase 3 showed 2x efficacy, 3x speed vs placebo
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- Submitted NDA to FDA for etripamil (CARDAMYST) for paroxysmal supraventricular tachycardia (PSVT) on Oct 24, 2023.
- Pivotal Phase 3 RAPID trial published in The Lancet; etripamil restored normal rhythm 2x more effectively and 3x faster than placebo.
- FDA 60-day filing review period to determine completeness; if accepted, standard 10-month review expected.
- Brand name CARDAMYST conditionally approved by FDA; commercial preparations underway for anticipated launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/0001104659-23-111088-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465923111088/tm2329058d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-111088

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