Actually FDA pre-sub meetings are generally bad news. It means something was flagged in review of submission requiring meeting discussion. MK says they're expecting FDA comments a week before meeting. Good news would be if comment received is something like: Looks great. No meeting needed. Carry on and submit IDE upon completion of outstanding items.
Meeting canceled would be best possible news.
Every meeting to date has meant more FDA suggestions and MK then wasting time resisting those suggestions, instead of getting FDA what they need to consider Radiogel for human trials. Why expect this time will be different?
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