RE:45-60 days prior to strategy updateTH is guiding towards a trial restart by the end of the first quarter. Would I be shocked if it took longer than that? Not at all. There is always a chance there could be some back and forth between TH and the FDA that chews up some additional time.
They will need to get going on cost cutting right away so hopefully, they will update us quickly about that. I can understand them not sharing the specifics of the new trial protocol until the FDA has signed of on it, but it would be really bad form to leave us in the dark about all other aspects of what is going on until the February Q4 conference call.
Joemare wrote: I 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.