“We want the DAWN results to be generalizable, to be simpler. We are exploring some more easily generalizable inclusion criteria that would allow us to treat more patients in more parts of the world,” Dr. Jovin added.
Both clinicians cited the remarkably low number needed to treat found in both DAWN and DEFUSE 3 of roughly three patients to produce one additional patient with a statistically significant and clinically meaningful improvement in their 90-day mRS score, compared with controls, as an unmistakable sign that the treatment in both trials was too targeted.
“When we planned the DAWN and DEFUSE 3 trials we didn’t expect how powerful the treatment effect would be. There are probably other patients who could also benefit, so how low can we go? How liberal can we be in our inclusion criteria and still get benefit?” Dr. Jovin asked.