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you sort of get to understand the advisory committee ‑‑ and I hope this meeting was really helpful to expose you to the different types of challenges we face on a daily basis in FDA and the struggle and how to bring science into it ‑‑ I think your advice and your input becomes very valuable for us to keep moving forward in the right direction and hopefully keep improving the science of what our regulatory policies are based on.

I think the two observations that I would like to make over the last two days, and the two observations I had for today's discussion, I think one was the manufacturing issues in terms of when we say that quality cannot be tested into a product, it has to be by design.  I think that is an area that we need to discuss a bit more because, for example, one of the aspects that we discussed was what happens if there is one unit has no drug or one has more drug, and how does the current system avoid that.

Again, I think the endogenous substances and the challenges you see in terms of customer satisfaction and the customer's physician, the challenge ahead is tremendous.  You can imagine in the sense of how do you

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