Soleno Therapeutics Provides DCCR Update, Continued Communications with FDA

PWSA | USA is happy to share the most recent news from Soleno Therapeutics regarding DCCR: This morning, Soleno shared that through continued dialogue with the FDA, the FDA acknowledged the data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a New Drug Application (NDA) submission for DCCR.
Families currently in the C602 study will be asked to participate in a randomized withdrawal study and their clinical site coordinators will be reaching out to discuss a plan.
For more information please read Soleno's press release by clicking the button below.

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