secwatch.observer — SEC 8-K summary
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Issuer:     Milestone Pharmaceuticals Inc. (MIST)
CIK:        0001408443
Form:       8-K
Filed at:   2024-02-26T23:59:59+00:00
Accession:  0001104659-24-027262
Event type: regulatory
Sentiment:  neutral
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Milestone Pharma plans to resubmit NDA for etripamil in 2Q2024 after FDA Type A meeting
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- FDA indicated that timing of adverse events had minimal impact on overall etripamil safety profile.
- No additional clinical efficacy or safety trials required before NDA resubmission; standard review expected.
- NDA resubmission for paroxysmal supraventricular tachycardia (PSVT) planned for 2Q2024.
- Cash conservation measures extend operating runway into mid-2025, covering expected PDUFA date.
- Upon FDA approval, Milestone would receive a $75M payment under an existing royalty agreement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1408443/000110465924027262/0001104659-24-027262-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1408443/000110465924027262/tm247232d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-027262

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