Share Price, page-22

Two theories being put forward here that I wanted to address…

That a high percentage of patients rolling over into the extension trial means trial success.

It doesn’t necessarily work that way. As I’ve mentioned before, Newron’s trial of sarizotan in Rett syndrome respiratory symptoms had an impressive 90% of patients rolling over into the long-term extension study at the end of the 6 month pivotal trial. Despite this, the Phase 3 trial was a complete failure - sarizotan met neither the primary endpoint nor the secondary endpoints and was terminated.

In the case of the Lilac extension trial, the waters are further muddied by the fact that in October last year, the trial's status was changed to enrolment by invitation only. We have no idea of the criteria used to determine who got an invitation, what impact this change in status had on participation numbers, nor the reason for the change.

That share price movement reflects insider knowledge from the extension trial.

Returning to the case of Newron - its share price rose by 86% in the weeks prior to announcement of its Phase 3 Rett trial results. Doubtlessly, some interpreted this late surge in price as a sign that insiders knew that the trial was a success. Or perhaps the rise occurred because the company reported that the treatment had been very well tolerated and that 90% of patients had elected to continue into the extension trial….