ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For neffy
Portfolio Pulse from Benzinga Newsdesk
ARS Pharmaceuticals has submitted a response to the FDA's Complete Response Letter (CRL) for neffy, addressing all additional requests including positive data from a repeat dose PK/PD study and updated testing showing no measurable nitrosamine levels. The submission triggers a review period of up to six months by the FDA.

April 03, 2024 | 1:04 pm
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POSITIVE IMPACT
ARS Pharmaceuticals, associated with the ticker SPRY, has submitted a comprehensive response to the FDA for neffy, potentially clearing regulatory hurdles and advancing towards market approval.
The submission of a comprehensive response to the FDA's CRL by ARS Pharmaceuticals, which is associated with SPRY, addresses critical regulatory feedback and presents positive study results. This action is likely to be viewed positively by investors and could lead to increased investor confidence in SPRY's ability to navigate regulatory processes and bring neffy to market. The positive data from the repeat dose PK/PD study under NAC conditions and the updated testing showing no measurable nitrosamine levels, in line with the latest FDA guidance, further bolster the case for a potential approval.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100