In an interview with Investor’s Business Daily, Anavex’s chief executive officer, Christopher Missling, called the controversy “an inaccurate impression.” He points out that the changes to the study were implemented in December 2021 and the website was only updated on January 18, 2022.
“The administrative updates on the website were not made on a timely basis by the CRO (clinical research organization), leaving the inaccurate impression of a late change, which was actually not the case,” Missling said.
He also said that the decision to select the RSBQ and the Anxiety, Depression and Mood Scale was made in December after all patients were enrolled but before the company had data on how the drug had performed.
“The misunderstanding was the information of the upgrade of the trial was done to this website at a late stage, giving the wrong impression that (the changes were) done at a late time,” Missling said.
Anavex’s decision to update the trial to Phase III was based on data from earlier trials, and that the new measures chosen provided a better idea of the drug’s benefit. In early January, at the JP Morgan Healthcare Conference, Anavex had described the trial as “pivotal,” a term typically used in the industry to describe a Phase III trial.