MediWound Ltd. (MDWD) shares are down 28 percent on Tuesday morning trade after U.S. Food and Drug Administration said it determined that the biologics license application or BLA for NexoBrid cannot be approved in the present form.
In the complete response letter, FDA said it has identified issues related to the Chemistry, Manufacturing, and Controls or CMC section of the BLA and requested additional CMC information. The FDA also wants to inspect NexoBrid's manufacturing facilities in Israel and Taiwan prior to BLA approval.
Subscribe to continue reading the article.
This article is part of our premium content offering.Subscribe with a RTTNews subscription.
Subscribe NowAlready subscribed? Sign in
For comments and feedback: editorial@rttnews.com