Re: BETonMACE top line data
in response to
by
posted on
Jan 18, 2018 01:00AM
BDAZ - I concur with your thoughts. I follow this story pretty close and have heard and seen in at least 4 different sets of meeting notes from different people from different meetings that if the SSA suggested they needed to for statistical purposes for various reasons, increase the trial participation numbers and number of events. 3600 patients and 375 3 point MACE events were the numbers that I have been used in all of those notes since before the trial started.
Unless someone has a video of DM saying "The trial will be over end of 2018. Enough said." I say this absolutely did not happen. DM is way smarter than that. I have heard him says on a number of occasions that this is biology, you simply can not come to a conclusion until the numbers come in. 2013 was a giant wake up call for everyone at the company. I simply don't believe a statement like that was made by anyone from the company anytime but specifically after June 2013.
Everything has been planned to have the Top Line read out by the end of 2018 but there were caveat statements made around that date as well. For a while it didn't look like that date was going to happen, now it does. For a while it didn't look like the FDA was going to happen, now it does. We still don't know how this FDA thing will affect this trial though.
BOM is a double blind trial. The info the company gets is very limited and what they do get they can't share with us. What they do share with us doesn't seem to be very clear so always remember "this is biology". When you see it in a news release in understandable words then you can believe it, maybe.
dyodd
tada