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kld2

07/26/14 2:59 AM

#364 RE: Gainsonly #363

Don't think it's so bad. As said in CRL, they have already submitted some amendments which address some of the issues, but FDA has not reviewed them yet.

If price drops 50%, might be a good opportunity to add. I mean, this isn't a new drug trial we're talking about. Some of the issues--like User's Manual, will be easy enough to address. We'll learn more on Monday. Dead money for now.