(Total Views: 642)
Posted On: 04/10/2023 7:05:38 PM
Post# of 153962
Quote:
Only problem is, it could restart the clock to 30 days?
The one positive in the sections about the clinical hold is that there seems to be a healthy dialogue and communication. So it appears the FDA isn't asking for an item and then waiting a full 30 days to respond. That might bode well for a lifting of the hold sooner than expected. Maybe they submitted the requested item last Monday and the FDA responded Tuesday. Doubtful but, again, there seems to be a much stronger working relationship between current mgmt and FDA than there was under the old regime.
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