Cytodyn Inc (CYDY)

[morokoy]

Found on another message board site.

Re: Interim Analysis - Jack
I've been involved in a couple of clinical trials and Luckjack has the interim analysis basically right. The company and clinical investigators are not unblinded. If they were it would end the trial. Only the DSMB is unblind to the results and they communicate with the company only in a few written yes/no responses (a faxed single sheet of paper with boxes checked in the trials I was involved with).

There is usually a futility analysis made by the DSMB and getting past that means something. That is, the DSMB looks at the results and their statistician makes a determination of whether the trial could possibly meet its endpoints with statistical significance if allowed to continue. For example, if a trial were half way done and there was no or very minimal separation between the treatment and control groups, then the statistics might show the trial could not possibly meet its endpoints. The company would be told that (Is it futile? yes/no) and in every case I know of that would cause the company to end the trial. So what we know is that that did not happen.