Aldeyra Therapeutics Says FDA Stated There Was A '"lack of substantial evidence of effectiveness" due to "a lack of adequate and well-controlled investigations" in the literature-based NDA submission'
Portfolio Pulse from Bill Haddad
Aldeyra Therapeutics' literature-based NDA submission faced criticism from the FDA, citing a lack of substantial evidence of effectiveness due to inadequate and poorly controlled investigations.
June 21, 2023 | 1:36 pm
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NEGATIVE IMPACT
Aldeyra Therapeutics' stock may face short-term pressure due to the FDA's criticism of their literature-based NDA submission.
The FDA's criticism of Aldeyra Therapeutics' NDA submission indicates that the company may face challenges in getting their product approved. This could negatively impact the stock price in the short term as investors may perceive this as a setback for the company.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100