Anavex Life Sciences Corp (AVXL)

[Doc328]

The FDA has always been, and remains, flexible. They are open to many designs that could be discussed at end of phase 2 meeting. They even say "This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page" in the guidance.

showing flexibility:
Lecanemab phase 3 Clarity used CDR-SB at 18 months as primary endpoint. They also successfully hit secondary endpoints ADAS-Cog14 and ADCS-MCI-ADL (a related scale to ADCS-ADL - with some overlapping questions and some additional questions)

Donanemab used iADRS (which is a composite of ADAS-Cog and ADCS-iADL) ADCS-iADL are the instrumental questions from the full ADL scale and are more sensitive for MCI and mild AD patients. The data was also significant for ADAS-Cog13 and ADCS-iADL independently as well as CDR-SB(secondary endpoints)

Simufilam (failed) used ADAS-Cog12 and ADCS-ADL as co-primary endpoints