FDA Issues Complete Response Letter For ARS Pharma's neffy® Epinephrine Nasal Spray, With Request For Additional Study; Company Plans To Appeal The Issuance
Portfolio Pulse from Benzinga Newsdesk
The FDA has issued a Complete Response Letter for ARS Pharma's neffy® Epinephrine Nasal Spray, requesting additional study. The company plans to appeal the issuance.
September 20, 2023 | 7:09 am
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
The FDA's request for additional study on ARS Pharma's product could potentially delay its market entry, impacting SPRY's short-term performance.
The FDA's request for additional study indicates potential concerns about the product's safety or efficacy. This could delay the product's market entry, which would impact SPRY's revenues and profitability in the short term. The company's decision to appeal the issuance could further prolong the process.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100