45-60 days prior to strategy updateI believe it's the minimum time before FDA comes back with a final decision regarding TH's proposal changes. I doubt we will get anything prior to that. This PAUSE is a little worrisome as efficacy was the issue for the pause. Ex. If efficacy was an issue for 7/8 indications assess, the PR would have been much different and efficacy for the '8th' indication would have been detailed. I think they can't ascertain proof of concept yet + efficacy (partial/complete/stable response) is likely less than 20%.
That sucks. I can tell you that no one was blinede to the trial data. They knew back in the summer they had issues and response rate sucked. I think heads should soon roll.