Replies to post #141016 on Biotech Values

[biomaven0]

JNJ has not publicly disclosed the reason for the 7-month delay they encountered from when they hit their interim events in January 2010 to when their DMC meeting occurred in August 2010.

Exactly. And in response to all the conspiracy-theorists, it cannot possibly be in JNJ's interest to delay this review - it can only potentially cause problems, for example if the FDA asks for an update and the update is unfavorable. Remember the company is blinded to the data until the DMC makes its determination that the trial should be halted.

I suspect the explanation is much more mundane - my guess is the DMC had some academics on it and they were away for the Summer. The sites potentially find out about deaths only some weeks after they occur, and then some lag while they report it and then some weeks for the CRO running the trial to figure out the trigger has been met and lock the database. Then a month or so to run the statistics and notify the DMC and try to schedule a meeting, and before you know it some key folks are gone for the Summer.

Good for Medivation but more importantly bad for the placebo patients that died before they could cross-over.

Peter