Table 22:

Development Plan

Year 1Year 2
Decision PointCostQ1Q2Q3Q4Q1Q2Q3Q4
#1 Clinical Formulation Development $250,000 $250,000
#2 Development Plan $300,000 $550,000
CMC program strategy Variable
Preclinical program strategy Variable
Clinical proof of concept strategy Variable
Draft clinical protocol design Variable
Pre-IND meeting with FDA Variable
#3 Clinical Supplies Manufacture $500,000 $1,050,000

From: Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies

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