Market RisksRisks include, but are not limited to: failure of DURAVYU in clinical trials, failure to obtain regulatory approval, failure to achieve commercial success due to market size, penetration rate, and/or competition, and potential dilution risk.
Therapy LimitationsDeclining rescue-free rates could dent the value proposition of a one-and-done therapy, as patients would anyway need to come in regularly for monitoring, perhaps more frequently with passing time.