“The additional time is primarily attributable to a decrease in the rate of enrollment which began in December and continued through January as well as delays in initiating several additional clinical sites for the study.”
“We will aggressively work to resolve the issues raised by these developments and provide additional information when it is available. We closed 2005 with $30.9 million in cash and short-term investments, which provides us with sufficient flexibility to continue our development programs.”
“While our clinical trial has been through its third and final scheduled safety review by our independent data monitoring committee and we are nearing completion of enrollment, safety issues always take precedence. Boston Scientific has requested a short period to review these latest (serious adverse events), and we have accommodated their request.”
“Boston Scientific has been an excellent and quality collaborator throughout this trial, and they have pledged an expeditious and thorough review of any issues identified on the catheter system or its use in our trial.”
