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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| Milestone Pharmaceuticals Inc | NASDAQ:MIST | NASDAQ | Common Stock |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 1.70 | 1.61 | 2.02 | 1.74 | 1.67 | 1.71 | 36,354 | 01:00:00 |
From Nov 2023 to May 2024
By Denny Jacob
Milestone Pharmaceuticals received a refusal to file letter from the Food and Drug Administration over its new drug application for its etripamil nasal spray to treat a type of abnormal heart rhythm.
The biopharmaceutical company said the FDA determined that the application for etripamil nasal spray as a treatment of paroxysmal supraventricular tachycardia wasn't sufficiently complete to permit a substantive review based on a preliminary review.
The regulator requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials, said Milestone.
Milestone said the FDA didn't express concerns about the nature or severity of adverse events. It will seek clarification and is planning a meeting with the FDA.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
December 26, 2023 07:42 ET (12:42 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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