Ascelia Pharma: FDA feedback confirms that Orviglance is on track for NDA submisison - Redeye
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Ascelia Pharma: FDA feedback confirms that Orviglance is on track for NDA submisison - Redeye

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FDA's final minutes confirm that Orviglance is on track for NDA submission by mid-2025. The final minutes’ feedback is an essential step in the pre-submission process, and both the timetable and the format are de-risked as a result.

Länk till analysen i sin helhet: https://www.redeye.se/research/1089117/ascelia-pharma-fda-feedback-confirms-that-orviglance-is-on-track-for-nda-submisison?utm_source=finwire&utm_medium=RSS

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