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IIS Concept Form

Phone Number:
Along with this Concept Form, I am submitting (check all the apply):

Outline Of Proposed Research

Resources And Plan

If one is required, do you have experience preparing and submitting INDs?
Do you have research staff that can assist with IND preparation and ensure compliance with IND requirements (e.g, safety and status reporting)?
Is your governing Institutional Review Board local or central?
Do you have an experienced research team that can support this study (e.g.,patient scheduling and evalution, data collection/management, statistical analysis, regulatory and records oversight)?
Approximately how long (in months) do you expect this research to take from first patient enrolled to final report?*
Are you requesting financial support from Avadel for this study? If Yes, approximately how much (ballpark; if your proposal is accepted, a detailed budget will be requested)?
Are you requesting drug product from Avadel for this study?

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