Ocular Therapeutix Said On Sept 12, Submitted Request For Special Protocol Assessment To FDA To Determine Whether Protocol For First Of Two Planned OTX-TKI Pivotal Trials In Wet AMD Could Support Marketing Approval
Portfolio Pulse from Charles Gross
Ocular Therapeutix has submitted a request for Special Protocol Assessment to the FDA. The request is to determine whether the protocol for the first of two planned OTX-TKI pivotal trials in Wet AMD could support marketing approval.
September 13, 2023 | 11:13 am
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Ocular Therapeutix's submission of a Special Protocol Assessment request to the FDA could potentially lead to marketing approval for the first of two planned OTX-TKI pivotal trials in Wet AMD.
The news directly pertains to Ocular Therapeutix and its ongoing clinical trials. If the FDA approves the Special Protocol Assessment, it could potentially lead to marketing approval for the first of two planned OTX-TKI pivotal trials in Wet AMD. This would be a significant milestone for the company and could positively impact its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100