Just spitballing here - Maybe the interim analysis was done at the originally planned time. I think it is certainly plausible that PFS appeared to have "failed," maybe related to the difficulty of accurately identifying pseudoprogression using their original study protocol. Maybe it even looked like DCVAX was making progressions occur faster than in SOC alone. This could make the FDA say, "you need to stop enrolling because the patients might be harmed by the treatment." The company could come back and say "it may look that way but here are some data indicating that this is not real progression. In fact, our patients appear to be living much longer. We think the drug is having significant clinical benefits." After some back and forth, eventually the company convinces the FDA that their arguments are valid, and the FDA lifted the hold because no new patients would be exposed to the treatment, so there was no added patient risk. The company then decided to continue the study as long as possible to maximize the OS data (going beyond the minimum target), knowing that PFS may look bad (but for explainable reasons). They would have even greater incentive to do so given the apparent FDA changes planned for these types of immunotherapies, particularly given that this is an orphan indication. The publication describing blinded OS data indicating that patients are living much longer than expected compared to a variety of SOC data sources then comes out. Everyone begins to realize that the treatment actually works in terms of increased survival. The rest is (future) history.
AI
Market Data 
Markets 
