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iwfal

06/09/07 11:48 AM

#4179 RE: maharajah #4177

483s are a big deal regardless of what it is for.

Some questions if you don't mind?

a) What percent of 483s are addressable quickly (e.g. without waiting for a full reinspection (in a month or two))?

b) Are you involved in NDAs or on-going ops? I would assume that there is a difference in company panic factor depending on whether it is already in production?
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masterlongevity

06/11/07 12:08 AM

#4245 RE: maharajah #4177

If they received a 483 for manufacturing issues, that is material IMHO. If an investigator working on the DNDN trial received a483, that would be immaterial.

byebye DNDN