Clinical Development RiskRisks include clinical development risk tied to GH001, GH002, and GH003, competitor risk, government regulatory risk, capital market and dilution risk, commercialization risk, reimbursement risk, pricing risk, and business development risk.
Regulatory ChallengesGH has completed all non-clinical inhalation toxicology studies requested by the FDA to address the Investigational New Drug (IND) hold for GH001 administration via its novel aerosol delivery device.
Trial LimitationsAll prior results have been in small, open-label datasets, which means the ph2b placebo-controlled readout will be the first true test for GH001.