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

The Biotech Adequately Funded So Likely To Comply

 
• By Sten Stovall

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

Soleno Therapeutics, Inc.'s hopes of marketing the first ever treatment for Prader-Willi syndrome (PWS) took another hit this week when the US Food and Drug Administration told the Californian pharma that an additional Phase III study evaluating its lead compound in the disease would be needed before a regulatory filing can be made.

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