Soleno Therapeutics Announces FDA Review Division Determined That There Does Not Appear To Be A Need For An Advisory Committee Meeting At This Time For The NDA For DCCR Extended-Release Tablets For The Treatment Of Prader-Willi Syndrome
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Soleno Therapeutics announced that the FDA has determined there is no immediate need for an advisory committee meeting for the NDA of DCCR tablets for Prader-Willi syndrome. The FDA will continue to review the application.
October 08, 2024 | 12:43 pm
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POSITIVE IMPACT
Soleno Therapeutics' NDA for DCCR tablets for Prader-Willi syndrome is under FDA review, with no immediate need for an advisory committee meeting. This suggests a smoother regulatory path, potentially boosting investor confidence.
The FDA's decision not to require an advisory committee meeting at this stage suggests a positive outlook for the NDA process, which could lead to a smoother approval path. This is likely to boost investor confidence in Soleno Therapeutics, potentially leading to a short-term increase in stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100