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whippinsaw

04/22/21 9:24 AM

#307901 RE: Mikesc #307899

Anavex got a delayed,, 18 year or older on low dose rett trial at fda, while the fda kept re writing cns guidances the delays cost missling time,, not gonna happen again,

Investor2014

04/22/21 9:28 AM

#307903 RE: Mikesc #307899

Whether a Basket Trial or some other trial protocol, an NDA must be filed with all the data and outcomes of the trial.

Doc328

04/22/21 9:47 AM

#307907 RE: Mikesc #307899

Did any other regulatory agency approve a basket trial that was denied by the FDA?