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FDA reached agreement on NDA submission plan regarding Ocular Therapeutix.

5 reports, 4 independent Updated 00:00

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Reports: 5
Developments: 3
Repetition: 40%

New informationRepeats or wire copies

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What happened

Well supportedReported by 4 independent outlets

FDA reached agreement on NDA submission plan regarding Ocular Therapeutix.

Who's involved

What this event is mainly about

FDADaniel F. Martin

How it developed

Newest first. Tap a step to see who reported it.

00:00Ocular Therapeutix targets AMD with AXPAXLI and aligns with FDA on regulatory path.1 source
- financialcontent.com
Jun 17FDA reached agreement on NDA submission plan for Ocular Therapeutix.1 source
- financialcontent.com
Aug 12FDA granted Special Protocol Assessment agreement for Ocular Therapeutix.1 source
- GlobeNewswire

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The entities involved

FDA
- FDA oversees drug trials in the US and Israel for Clearmind Medicine Inc., which is listed on Nasdaq.15:43
- CalciMedica reported trial results from La Jolla and is seeking FDA alignment on its trials.14:56

Related events

Coverage

Newest first; wire copies grouped

00:00financialcontent.com
Sep 23yahoo.com
Sep 3insidermonkey.com
Jun 17financialcontent.com
Aug 12GlobeNewswireOcular Therapeutix™ Receives FDA Agreement Under Special Protocol Assessment (SPA) for Registrational Trial of AXPAXLI™ in NPDR Ocular plans to outline clinical trial design, timing, and development