The Synergy trial design poster (I believe 2011 ASCO), mentions an interim.
" Sure seems as though performing a late efficacy interim"
I dont think this is late. I think 75% (or 80% according to others), is a clever time to do the interim. At the end it's an interim. No one expects the interim to be successful anyway. It also allows DMC signal the co not to hurry with the final if the trial is a close call.
" (if not to inform a filing team)"
I'm not sure I follow this. What's the purpose of this?
You should look at this trial design and especially ENSPIRIT's design from TEVA's perspective. I believe TEVA would want to get out as soon as possible if they realize the trial data is not looking good. That's why I believe the Synergy's futility was a real futility analysis.
Summer, I'm not sure whether this has any significance, but my recollection is that there was a pronounced shift in the way OGXI talked about the interim about a year ago. Prior to that, they said little if anything about it in their SEC filings and when asked about it in CCs Scott Cormack would usually respond that there would be an interim but that unless it showed clear futility the trial would continue to the final. In other words, he made it sound as though there would be only one interim which would essentially be a futility analysis. I haven't been able to determine exactly when he announced that there would be two futility analyses and an interim efficacy analysis but as I say I think it was about a year ago, and I know it was in the Q1 CC in May that he said they'd passed the second futility and that the next interim would be for efficacy.
Is it possible that the design was changed midway through the trial, with an amendment to the SPA?
In any case, Cormack is no longer pooh-poohing the possibility of an early stop for efficacy. When you say no one expects the interim to be successful, I can't tell if you're speaking for yourself or the market or both, but if true I almost think Cormack should have stuck to the original strategy of totally downplaying the interim's importance. I've always agreed with you that the company should be more transparent but in this instance he may have raised hopes which if dashed might hammer the pps.
Separate question: in a different post you say that if you were Teva you'd have guided the doctors towards patients who'd already used ketoconazole. Is that because such patients are ineligible to use Zytiga or because they don't respond well to it? And can the doctors be guided to choose patients on a basis that's not mentioned in the trial's inclusion or exclusion criteria?
Finally, I too remember Cormack saying multiple times that the FDA would allow a filing based on SYNERGY success because of the P2 trial.