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

Free
Message: Biogen looks to FDA for approval of early Alzheimers drug.

Koo wrote: "There you go..."In essence, Sandrock said, the futility analysis had happened too soon." Perhaps if BOM went for a longer stretch, it would have netted better Top-Line results."

Two issues there. 1) Remember BETonMACE skipped its planned futility analysis. Who knows what the outcome would have been if the futility analysis or sample size re-estimation interim analyses had happened as originally planned. Would it have been stopped for futility or allowed to continue? 2) As for longer duration of BETonMACE netting better Top-Line results.....we will need to see the full BETonMACE data to understand whether or not there was a near miss or a total miss. If near miss, then yes perhaps longer duration, or more patients, would have yielded a positive top-line outcome. If total miss, then longer duration probably would not have mattered.

BDAZ

Share
New Message
Please login to post a reply