Patients who were switched to a variety of doses of the medication after initially getting a placebo continued to decline, an unexpected finding, Relkin said. After a year of therapy, all were switched to the intermediate dose and stabilized, showing the dose of the medication is critical, he said.
A U-shaped dose response would, to me, imply substantially less credibility than the absolute numbers imply. And even if true that it has a U-shaped dose response it will make it much harder to get it right in ph iii.