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We are transferring ownership of an IND as a new sponsor to a CV product. The previous sponsor has has conducted initial ph 1 single and multiple ascending dose PK/PD studies in healthy subjects over 6 years ago and reports are finalized and submitted under original IND (IND still active) . As the new sponsor, our intent is to go for a different indication than was originally shared with the FDA by the previous sponsor. The studies/intact IND still apply to the new indication and we plan to request a FDA mtg to discuss plans for a phase 2 protocol. Is a new IND application required first, however? All the previous data would apply as is and would be the same package previously submitted to the existing IND, re-summarized. Our briefing package would re-summarize it briefly anyway. Should we just pose the question that we believe the current IND is still "valid" as is?
Or, Should I try to network ahead of time with the division (once IND is fully transferred)?
Thanks for you input.