Anavex Life Sciences Corp (AVXL)

[Investor2014]

Suggest these two articles may be helpful.

Both to be seen in context of what the Anavex PR actually says and the lequembi AA and Confirmatory P3 trials, not P4!

FDA oncology chief aims to open up accelerated approval for earlier cancer treatment under 'Project FrontRunner

Since that article, ADC Therapeutics revealed that its bid for an accelerated approval for camidanlumab in relapsed or refractory Hodgkin lymphoma was delayed because the FDA wants its phase 3 confirmatory study to be “well underway and ideally fully enrolled” before a filing.

Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway

Among 127 accelerated approval indications with confirmatory trial requirements, 89 (70%) had confirmatory trials started before approval. Accelerated approval indications with confirmatory trials started before approval had higher proportions of conversion to traditional approval or withdrawal by 3 years (39.3% [35/89] vs 13.2% [5/38]; P?=?.003) and 5 years (76.2% [48/63] vs 26.9% [7/26]; P?<?.001) than indications that did not have pre–accelerated approval trial initiation. Regulatory outcomes within target timelines were not statistically significantly different between indications with and without preapproval confirmatory trial initiation (42.0% [34/81] vs 23.8% [5/21]; P?=?.13) (Figure 1).