FDA just published the full CRL for AQST / Anaphylm - Showing critical issues that AQST tried to downplay

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)