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Re: 98beamer post# 281783

Sunday, 11/08/2020 6:15:51 PM

Sunday, November 08, 2020 6:15:51 PM

Post# of 458380
Very simple answer:

PDD Phase 2 results were excellent...but it was a Phase 2 trial. (FDA will most likely require a P3 trial before approval)

Rett trial called "EXCELLENCE" is a Phase 2/3 trial...The FDA has already granted them Orphan Drug and Fast Track status. This means that they should get immediate approval if results are great...which would transition Anavex from a clinical-stage biotech company to a full fledged pharmaceutical company.

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"The U.S. Food and Drug Administration has granted Anavex-2-73 orphan drug, fast track, and rare pediatric disease designations for the treatment of Rett syndrome. Each designation works to facilitate the development of medications to treat serious conditions and fill an unmet medical need.

Anavex-2-73 also is being explored as a potential therapy for people with Alzheimer’s disease and Parkinson’s disease dementia."


https://rettsyndromenews.com/2020/07/08/first-patient-dosed-excellence-trial-testing-anavex-2-73-children-adolescents-rett-syndrome/

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