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Ann: Athenex submits Avecho's phytonadione to FDA pre-IND, page-6

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FullMoonFever

6,168 Posts.

2665

12/01/23

14:37

Post #: 65659081

Well, another bit of positive news with some potential.

Nice to read.

Presume will be under the following timeline and if so, maybe we will get an update re the meeting request response after the 21 days then another for the outcome (if meet granted) not long after the 60 days.

Table: Timelines for Pre-IND (Type B) Meetings
OTAT Response to Meeting Request** 21 days
1 Meeting Scheduled or WRO issued*** 60 days
2 Meeting package due to OTAT At least 30 days before the scheduled date of the meeting or WRO
3 Meeting Length 60 minutes
4 OTAT Preliminary Response to questions in the package to Sponsor (for teleconferences) NLT* 2 days before the meeting
5 Sponsor’s Response to FDA preliminary response (for teleconferences) NLT than 24 hours before the meeting

	OTAT Response to Meeting Request**	21 days
1	Meeting Scheduled or WRO issued***	60 days
2	Meeting package due to OTAT	At least 30 days before the scheduled date of the meeting or WRO
3	Meeting Length	60 minutes
4	OTAT Preliminary Response to questions in the package to Sponsor (for teleconferences)	NLT* 2 days before the meeting
5	Sponsor’s Response to FDA preliminary response (for teleconferences)	NLT than 24 hours before the meeting