Anavex Life Sciences Corp (AVXL)

[dia76ca]

The Aussie version of the FDA is very well acquainted with 2-73. In August 2020 they granted Compassionate use(SAS) status to 2-73.
Here is some background.
" Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies."
IMO I would not be surprised by some sort of expedited approval in Australia