Anavex Life Sciences Corp (AVXL)

[Doc328]

Companies are allowed one pre-IND meeting with the FDA in general. So not really a back and forth. I don't know if they can do another meeting before a re-submission.

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.

To promote efficient management of formal meetings, the requestor should try to anticipate future needs and, to the extent practical, combine product development issues into the fewest possible meetings. Generally, we will not grant more than one of each of the Type B meetings