Replies to post #112468 on Avid Bioservices Inc (CDMO)

[BioBS2012]

Why would you state the 60-90 days as matter of fact

Maybe because an end-of-Phase 2 meeting falls under a Type 2 meeting?

B. Type B Meeting
Type B meetings are as follows:4
•
Pre-investigational new drug application (pre-IND) meetings (21 CFR 312.82)
•
Certain end-of-phase 1 meetings (21 CFR 312.82)
•
End-of-phase 2 and pre-phase 3 meetings (21 CFR 312.47)
•
Pre-new drug application/biologics license application meetings (21 CFR 312.47)
Type B meetings should be scheduled to occur within 60 days of FDA receipt of the written meeting request. If a sponsor or applicant requests a meeting date that is beyond 60 days from the date of request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.

And because once the meeting is completed....

X. DOCUMENTATION OF MEETINGS
Documentation of meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this information is preserved for meeting attendees and future reference. FDA minutes are the official record of the meeting. The official, finalized minutes will be issued to all FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days of the meeting.

If you add the 60 days from meeting request to the 30 days for the formal minutes, your get 90 days for decision - though obviously a decision would be pretty much known at the meeting itself. The above is from FDA Guidance Document titled:
Guidance for Industry
Formal Meetings Between the FDA and Sponsors or Applicants