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Re: Boopka post# 458979

Tuesday, 05/14/2024 10:09:11 AM

Tuesday, May 14, 2024 10:09:11 AM

Post# of 461943
As I understand it there are two things to consider. First is there is a great deal of commonality between the EMA and FDA filings, so much of the work only has to be done once. For the differences between the two there are outsourcing companies that can do the multiple language requirements for the EMA that the FDA doesn't have.

There are also companies that specialize in creating NDA and MAA packages at what ever level of capability a company requires. All they way from complete NDAs to individual sections as needed.

So to me that means that Anavex can do what it can in house and outsource what it feels it doesn't have the resources to do.

One other consideration is that the staff Anavex has is very well equipped to supervise any outsourced work and verify the quality and correctness of the work product prior to submission.

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