Oct. 6 at 9:04 PM
$AQST Can the FDA approve Anaphylm before the assigned PUDFA date of 1/31/2026? Here’s what AI had to say and I agree, I also think it will happen when we least expect it:
AI Overview,
Yes, the FDA can approve Anaphylm before its assigned PDUFA date of January 31, 2026. While PDUFA dates are target dates, the FDA has the discretion to make an approval decision sooner if they are confident in the drug's safety and efficacy, as indicated by their decision to forego an advisory committee meeting for Anaphylm.
The FDA is not required to make a decision by this date.
Why an earlier approval is possible:
The FDA's review process is not always linear; they can and sometimes do approve applications before the PDUFA date.
The decision not to hold an advisory committee meeting for Anaphylm, which took place in September 2025, suggests the FDA is internally satisfied with the data and believes the product is suitable for approval.
