Milestone Pharmaceuticals Aktie
WKN DE: A2PHG6 / ISIN: CA59935V1076
16.06.2025 14:36:01
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Milestone Pharma Announces Submission Of Its Response To CRL Regarding NDA For CARDAMYST
(RTTNews) - Milestone Pharmaceuticals Inc. (MIST) announced submission of its response to the FDA's Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. The response follows a Type A meeting recently held with the FDA. The company noted that the review time is expected to be within 2 or 6 months from the resubmission, depending on the classification.
"Our recent Type A meeting with the FDA was productive and we believe it provided the guidance necessary to submit our response to the CRL directly after the meeting," said Joe Oliveto, President and CEO of Milestone Pharmaceuticals.
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Milestone Pharmaceuticals Inc Registered Shs | 2,14 | 4,15% |
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