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flipper44

03/28/16 7:11 PM

#57794 RE: Ready4bluesky #57790

Nope. I think the risk section is chocked full of every conceivable issue that could come up.

Did you notice this sentence right after the quote you posted?

There is also some possibility that changes requested by the FDA and/or other regulators could complicate the application process for product approval.



That one seems a bit more interesting. It sounds more along the lines of what Smith discussed -- there is a missing puzzle piece.