The Harv made it very clear that they have met every agreed upon level from the SPA. The ASCO results will only hold interim data on the Overall-Survival but from what it sounded like, there will be a trend in favor of O.S. but he made it clear there wasn't an agreed up hazard ratio or other terms that must be met for the drug to be approved as the SPA is NOT based on OS data.
Heck, he even said ODAC isn't necessarily going to meet regarding approval of this drug.
The Q&A was very informative (as is the case usually - the meat and bones of the presentation is a snoozefest)...lots of good questions from the audience.
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