Jan. 17 at 7:12 PM
$AQST For some reason, er'body has their imagination go to the worst outcome, when it comes to a deficiency notice. While it is possible we do get the worst outcome, a CRL denying Anayphylm, at this point, er'body seems to be ignoring all the signs that a CRL won't occur.
Let's break down the notice, its phrases and see what we find.
This thread will be long and continued in replies.
1. Precluding "Discussion of Labeling and Post-Marketing Commitments at This Time"
Labeling and post-marketing discussions are end-stage activities. They only kick in once clinical efficacy/safety, PK/PD major CMC reviews are essentially satisfied. If core data had major flaws, the FDA wouldn't be at this stage. They'd be organizing a CRL.
2. Explicit Statement That Review "Remains Ongoing" and "No Final FDA Decision Has Been Made"
This is done for emphasis & means work continues with AQST and engagement is occurring. If the FDA saw issues as major they'd often signal denial language.
Cont....
