secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2025-06-16T23:59:59+00:00
Accession:  0001104659-25-059671
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone submits CRL response for CARDAMYST (etripamil) PSVT NDA after Type A meeting
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- Submitted CRL response to FDA on June 16, 2025, following a productive Type A meeting.
- FDA will determine acceptance and set PDUFA date within 30 days.
- Review timeline expected to be 2 or 6 months depending on classification.
- CARDAMYST, if approved, would be the first self-administered therapy for acute PSVT episodes.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/0001104659-25-059671-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465925059671/tm2518093d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-059671

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