Soleno Shaken By FDA Demand For Second DCCR Phase III Trial In PWS

The Biotech Adequately Funded So Likely To Comply

The US FDA has asked Soleno to conduct another Phase III Study evaluating its chief asset in Prader-Willi syndrome patients prior to any NDA submission, rattling investors and clouding the company’s prospects.

Clinical Trial
Additional controlled clinical trial needed to support an NDA submission

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