Flipper - Setting aside the "1 million pages," what about the so-called rolling programs launched to move away from the status quo? If not for the purpose of submitting the paperwork in phases, then frankly, they're not doing anyone any favors. I think it's short sighted to wait to submit 1 million pages, and then have the regulators start their review. We are talking months to review an application. I've been there for a fish oil derivative. Imagine what an immunotherapy will require? Obviously, I'm not partial to the happenings, but it almost feels like we have the FDA waiting around for the documents to come in. From what I understood, these formats are to be collaborative in nature. Waiting for 1 million pages doesn't seem to fit the bill, if that's what's happening.
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