Anavex Life Sciences Corp (AVXL)

[Doc328]

The Australian Avatar study required that the initial 3 patients be open label--- similar to the US Rett study having 6 patients open label for PK/PD. Was the TGA "rewriting cns guidances the delays cost missling time". AVXL would have included the 6 patient data in the CTA (IND) Investigator brochure for the Avatar study reviewed by the TGA. Yet the TGA insisted on additional 3 patients open label. Was the TGA unreasonable? It looks like the TGA is even more cautious than the FDA.

not gonna happen again,

except in Australia for the Avatar study