Efficacy data?, page-12

If you read the transcript or listen to the conference call bolding is from me. Unless you got a large unanimous improvement or there were safety issues i.e. adverse events or strong signal that it caused harm the dsmb would not remove the blind for the company. It negates the purpose of the trial.

Now if you saw in the blinded data average MMSE increasing post intervention that would be a good sign but placebo is not completely a placebo treatment because the patients are being subjected to a battery of cognitive tests and being stimulated by being involved in a clinical trial and these sort of activities have been shown to help with cognitive decline so potentially the placebo effect could be quite good but management think its because of xanamen.

Bill did say the baseline MMSE was about 22.5 not sure if he would tell us what the post treatment MMSE was sitting at. Anyone want to ask?

The following is from the transcript

Bill Ketelbey: Okay, well let me start by saying we obviously have the blinded data, we don’t have the un-blinded data, so we are unaware of the outcome from that. The DSMB evaluated, while they evaluated the data, they provided - the recommendation they provided was, as we said, the recommendation to continue the trial without modification. Now the reason we have blinded the study and the reason we've been very diligent and rigid about maintaining the blind in the study is to ensure the ongoing integrity of the trial. The end points in Alzheimer's clearly are subjective end points and anything leaking from the blinding of the trial has the potential to obviously undermine the potential future patient coming into the trial.

So the DSMB recommendation to us to continue the trial without modification is the total content of our feedback on both the efficacy and safety. But what we can take from that is a sense of confidence that there is no treatment-related adverse events, there is no safety concern, there is no recommendation from the DSMB to make any changes either related to safety or patient numbers or patient profiles. So we take from that that the drug is safe in this patient 6 population and appropriately safe in this patient population and that the assumptions we made in the design of the trial appear to be correct.