Can you clearly define your addressable market?
KEY ISSUE: Typical epidemiology studies are not designed to support commercial forecasting
Does your study design strategically align with target patient segments and payer expectations?
KEY ISSUE: Identify addressable patient populations from study protocol through to approved PI
Are you credibly translating market share from primary market research to
your forecast?
KEY ISSUE: Ensure structured & defensible preference share calibration
Have you assessed how pricing and payer access dynamics will shape adoption?
KEY ISSUE: Proper design of payer market research, analogue selection & value framework
Are your global forecasts robust enough to support licensing efforts abroad?
KEY ISSUE: Credibly assert ex-US projections even at early development stage
