48 RESULTS
COMMENT This may have been the fourth randomized Phase 3 trial of a form of methylene blue in various doses by this company. None was statistically significant compared to their contemporaneous controls. The trials used a small dose of HMTM or similar as the cont
COMMENT The Perfect Meeting Three years ago, an FDA adviser called the agency’s approval of Aduhelm “probably the worst drug approval decision in recent U.S. history.” By contrast, a current adviser called today’s donanemab session “a perfect meeting.” FDA got th
COMMENT Of course, clinical and biomarker effects could grow. If your model is projecting the slope of an existing difference it will grow over time, assuming that the conditions remain constant. That is, if the benefits of the drug in reducing plaque are durable
