Replies to post #439565 on Anavex Life Sciences Corp (AVXL)

[HMB2010]

Right ?!? I thought would be Australia first. Either way Works !$!

[Steady_T]

Based on the information provided by boi568, I would expect the FDA application for AD to be in process and possibly approved before the EMA application.

Seems to me that an application in Australia for AD will be next up. Looks like the AU procedures are faster.

a pre-submission planning phase where applicants lodge details of a proposed application at least 2¼ months prior to lodgement of the dossier allowing the TGA to identify milestone dates and plan resource requirements (this is not required for submissions lodged in eCTD format if the sponsor selects the PPF-only option)

If that is accepted the evaluation process starts. Typically taking 10.5 months.
There is a priority review process in AU that reduces the approval time line to 150 working days vs 220 working days.

2.4.5 Priority review designated applications
TGA now has a formal Priority review pathway for faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. A valid Priority review designation must be held in order to access the Priority review pathway.[/quo
Based on the eligibility requirements it appears that Anavex is eligible for priority review but Anavex must apply for that designation.

[Anshu2]

FDA doesn’t get swayed by anyone else. Rightly so.

AVXL has zero approval chance from FDA at this point — why? Because CM I has done nothing about it for 1.5 years, so he is himself telling us.