Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

December 19, 2023

https://www.globenewswire.com/news-release/2023/12/19/2798509/0/en/Outlook-Therapeutics-Submits-Special-Protocol-Assessment-SPA-to-FDA-for-Non-Inferiority-Study-of-ONS-5010.html

ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) — Outlook Therapeutics, Inc. (Nasdaq:OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that, following receipt of written confirmation of the NORSE EIGHT proposed clinical trial protocol with the U.S. Food and Drug Administration (FDA), Outlook Therapeutics has submitted a Special Protocol Assessment (SPA) request for the required additional adequate and well-controlled study of ONS-5010.

Read more at globenewswire.com

Related news for (OTLK)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.