Anavex Life Sciences Corp (AVXL)

[CkFacts]

AGREE LIMA !
Doc , while stating several facts , you have also seemed to disparage / downplay the validity of a highly respected scientific publication ( Nature Research / Signal Transduction and Targeted Therapy) and the credentials of their equally highly qualified and internationally recognized editorial review boards . It appears that the publication underwent approx 5 MONTHS of peer review before eventual publication under NATURE’s name . My opinion is that the reference to Anavex was vetted and is accurate .

Doc’s third point , while factually accurate , again appears to underplay the HIGH SIGNIFICANCE of a fast track designation, which can have significant benefits in shortening the time line to approval .

Benefit 1 : more frequent meetings with FDA ( and we have strong FDA contact on staff )

Benefit 2 : Rolling Review - - EXTREMELY IMPORTANT — means that Anavex can submit completed sections of its New Drug Application ( NDA ) individually for review by the FDA , rather than having to wait Until all sections are complete and submitting entire application for review , as is the normally the case with a new drug Application .

Benefit 3 : This Fast Track Designation also opens up the opportunity for PRIORITY REVIEW and / or ACCELERATED APPROVAL , provided certain data criteria are met .
With now over 4 years of human trial data from the Australian trials , I believe we have quite a large “ iceberg “ of data to share with the FDA !

God Speed to Anavex in moving forward to providing relief to millions of sufferers of several devastating CNS diseases .

PS : All of above just IMHO ! Looking forward to great news in the coming months !

GLTAL