...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: List of things that point to postive data.

"...the trial ending so late tells the drug is working!"

Not this again. Way too many unknowns to assume success based on chronological time, especially placebo event rate and number of patient years. Patient years is the more informative measure. Recall BETonMACE was originally designed to hit 250 events in 3600 patient years. Are we at 3600 yet? Maybe, maybe not. Also, trial design was largely modeled after the event rates in the EXAMINE trial. Although it is a great model, the placebo event rate in BETonMACE may be below expectations.

"9  DSMB postive safety data points, if there was any safety issues over the past 3 years they would have halted the trial"

Safety doesn't equal efficacy. And just because no safety issues have been voiced by the DSMB doesn't mean that apabetalone is in the clear for not having increased adverse events. Perhaps nothing severe or frequent enough to warrant a DSMB intervention, but we won't know the detailed adverse event profile until the full data gets scrutinized.

BearDownAZ

Share
New Message
Please login to post a reply