Anavex Life Sciences Corp (AVXL)

[nidan7500]

Doc...thanks for grounding all of us in the reality of dealing w/regulatory bodies during times of change. Can you say ,in this context, how the new "precision Medicine" trials rules are being developed/applied. Are these guidance or are they requirements being applied to the first trials and how is RWE being treated? If new learning occurs which change the trial plans, do they stop/go back and restart or evolve as they go? TIA

How does an enterprise establish a IND protocol with these process controls in place?

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