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So Ocyan, Are you still optimistic about the final with this new information we have today or has anything changed in your opinion?>
The data released today clearly says that Provenge works. My guess for the weakness of the interim is that efficacy of Provenge was somewhat reduced because of the minimal pain condition in the IMPACT enrollment protocol.
For a treatment like Provenge with a delay effect, it is hard to tell how long that effect lasts and then how much faster the efficacy ramps up afterward. The relative fast separation near the end of the survival curves in D9902a was a good example. If that also holds up for IMPACT, then the HR for the final might be better than DNDN aimed for.
In any case, a large number of trials are powered at 80% based on relatively weak data from earlier phase-2 trials. So a 60% as shown in my previous post is a decent chance. If the final succeeds, good. If it misses, it won't miss by much. And, as I mentioned, if they follow the data to 360, then it's very likely that the trial will meet statistical significance.
So, even in case of a miss at 304, I believe that there would be three phase-3 trials with mutually supportive data on efficacy and safety. Some sort of avenue will likely be explored to continue testing the drug or to get it to patients. The stock price today might be a reflection of that.
