Market AdoptionThe market model has been adjusted to reflect a slower adoption of the immune-ablative approach for intermediate-risk patients, as it deviates more from current practice.
Regulatory ChallengesConcerns about the single arm design of the ENVISION trial, which the FDA views as insufficient to assess duration of response.
Sales ForecastOverall peak sales for bel-sar in bladder are now estimated at $800 million, down from a previous estimate of $1.1 billion.