Anavex Life Sciences Corp (AVXL)

[Steady_T]

AA does not get approval faster than regular approval time after submitting an NDA.
Lecanemab took 9 months after it completed its rolling submission before it received accelerated approval.

Accelerated approval does not mean the actual approval review process is faster. That come from fast track designation or the use of a voucher. Anavex has fast track for Rett but not for AD.

Having rolling submission designation should make the approval process shorter but it did not in lecanemab's case.

We have been thinking of AA as meaning a more rapid approval process after submission. That is not the case. What accelerated approval means is the ability to use a surrogate endpoint in place of waiting for and endpoint that would take a much longer time such as survival of cancer which in normally a 5 year period. Or in the case of AD a reduction in plaque instead of waiting 3 or 4 years to measure the rate of decline.