[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Adam Feuerstein ✡️ [@adamfeuerstein](/creator/twitter/adamfeuerstein) on x 119.4K followers Created: 2025-07-22 11:02:18 UTC From the $REPL release: The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised. XXXXXX engagements  **Related Topics** [repl](/topic/repl) [$repl](/topic/$repl) [Post Link](https://x.com/adamfeuerstein/status/1947613166222938295)
[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]
Adam Feuerstein ✡️ @adamfeuerstein on x 119.4K followers
Created: 2025-07-22 11:02:18 UTC
From the $REPL release:
The CRL indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised.
XXXXXX engagements
