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Has anyone had success submitting and conducting studies with multiple objectives as part of an initial IND submission in the US? One such example would be conducting single and multiple ascending dose studies under one protocol. If so, I would be interested in learning more about made it successful (or conversely, what problems were encountered) and what FDA review division was involved.
Many thanks in advance,
Joi
Joi Dunbar
Clinical Pharmacology
Infinity Pharmaceuticals
780 Memorial Dr
Cambridge, MA 02139
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