- Entry
- $4.37
- Final
- $4.99 +14.2%
- Target
- —
- Score
- -1.00
FDA just published the CRL for $AQST ’s Anaphylm and it’s very different from the version the company implied. AQST framed the rejection as mostly “packaging” issues. The actual CRL shows usability failure in a life-threatening scenario that AQST tried to downplay. FDA now requires a new human-factors study and a new PK study before resubmission. Read the CRL yourself: [https://download.open.fda.gov/crl/CRL\_NDA219870\_20260130.pdf](https://download.open.fda.gov/crl/CRL_NDA219870_20260130.pdf)
— ORIGINAL POST ·
FDA just published the full CRL for AQST / Anaphylm - Showing critical issues that AQST tried to downplay
· r/stocks
· Mar 5, 2026