I am encouraged by that responce it indicates that there is further existing data available that may satisfy the fda which follows my thoughts that all the first phase 3 data is still available and I would assume still relevent. Maybe the outcome will work out ok, timing is in the fda's hands we or spl can do little about that however the company should be well prepared with ex fda consultants on bo
Just Wondering about Promises and Timeing, page-11
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