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Redeye comments on Isofol notifying the market that AGENT’s censoring rules/trigger point seem to need change for data analysis to commence. We understand that at least 141 patients proceeded to another treatment before experiencing tumor progression, i.e., the study will not reach the trigger point of 300 PFS events according to the original censoring rules. The primary endpoint ORR remains unaffected. We perceive that Isofol merely needs to agree with FDA on adjusting the censoring rules and/or the trigger point to allow for data analysis as we advance. We judge the news make AGENT reaching its secondary PFS endpoint with statistical significance/a clear trend towards significance at least marginally less likely.
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