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Investor2014

08/05/22 12:28 PM

#369219 RE: Doc328 #369218

Yes and if not for other reasons, that is certainly one why no NDA will be filed for Rett until hopefully great confirmative data is in from the Excellence study.

Altogether, that would most likely put out a Rett approval into 2024.

Gator328

08/05/22 12:42 PM

#369222 RE: Doc328 #369218

Thanks. This does not sound like it will bode well for Anavex when it has to present data to the FDA, unless there is a very good reason for changing the endpoints.

The saving grace may be the lack of other effective Rett treatments, but it seems a bit sketchy they aren't releasing the original endpoint.

I really need to start following this company more closely but these trials take so long. I admire those who are able to stay invested -- no pun intended -- in the various updates day in and day out for so many years.

As always, I appreciate your perspective.

powerwalker

08/05/22 12:44 PM

#369224 RE: Doc328 #369218

So, Doc, which set was more difficult to meet: the initial set or the revised set of endpoints?

TIA


ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!

catdaddy

08/05/22 12:58 PM

#369225 RE: Doc328 #369218

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.