Kennedy R. Lees, MD, FRCP, Tim Ashwood, PhD, Tomas Odergren, MD, Response to Letter by Proctor and Tamborello, Stroke, published on-line, August 25, 2007

Response

"....the suggestion that different products were used for the 2 SAINT trials can be discounted. Relevant knowledge contained in the patent application was applied identically to the study drug supplied for SAINT I and II. The patent application for test article preparation was filed in Sweden in May 2000 and filed internationally in May 2001. SAINT I commenced in April 2003. The suggestion that the SAINT I trial may have been delayed pending animal toxicity tests is also untrue. Appropriate testing was completed before early phase trials. The SAINT I protocol was finalized in December 2002, after the last of the preclinical efficacy studies advised by STAIR guidelines had concluded.1,2 Recruitment to SAINT I started promptly after Institutional Review Board and regulatory approvals, in April 2003, and completed ahead of schedule.3,4 "