RE:Next ... fast track & breakthrough designation
So we must understand that the company already has fast track designation for this indication as they do with the panc.
Also of note is they are talking about 2 primary endpoints for the trial and not just one so that if pfs for example does not meet the trial endpoint then they move on to the os part of the trial so it COULD reduce the timeframe for meeting the trial endpoints but might not. The issue with the pfs as it did show well in the bracelet trial but not in the mbc213 trial and even the kol panel was not sure how to interpret this other than the fact the the 213 trial patients were more heavily pre-treated than the bracelet trial patients so discussion with the fda and potential partners will be most important when determining the trial endpoints.
Bottom line is there is no guarantee that the readout will come earlier unless the pre-determined trial endpoint is met. Honestly if the company were offered a decent buyout that would be the way to go and remove all doubt and anxiety but at what price is the question. We all would like to think that the 5 -10 billion is possible but realistically if they were offered 2 billion or more it should be considered IMO only of course. Overall the kol meeting was good and informative but still leaves a lot of questions so now time for the fda and potential partner meetings and hopefully the possible partner announcements before year end as was suggested.