Anavex Life Sciences Corp (AVXL)

[F1ash]

What is the speculation here?

Although Anavex PR’ed that the first patient was enrolled in the Phase 2b/3 study in Australia,

“First Patient Enrolled in Anavex Life Sciences Phase 2b/3 Clinical Trial of ANAVEX®2-73 for the Treatment of Early Alzheimer’s Disease”

Apparently they have yet to register that trial on the Australian or combo Australian/ New Zealand Clinical Trial registration site. Neither have they registered the trial on the US Clinicaltrials.gov website.

It appears the 2a trial and the subsequent extension were registered only on the US Clinicaltrials. gov website and were copied to the combo Australian/New Zealand from the US registration.

http://anzctr.org.au/TrialSearch.aspx?searchTxt=Anavex+&isBasic=True

“For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT0275685”

I won’t quote the reasoning behind why trials are supposed to be registered before enrolling again lest I be berated for repeating myself. Let’s just say it’s a good idea to register a trial before enrolling. That has not happened in this case apparently.

Why? It could be an oversight, but I think a poster reached out to IR and the non- registration issue still exists apparently.

https://clinicaltrials.gov/ct2/results?cond=&term=Anavex&cntry=&state=&city=&dist=

Why do you think the trial has not been registered?


For OFP:


“My study is not yet approved by a human subjects review board (ethics review committee, institutional review board). Can I enter it on ClinicalTrials.gov?

Most studies require approval from a human subjects review board. If your study requires approval, you may register your study on ClinicalTrials.gov prior to getting approval if the Overall Recruitment Status of the study is Not yet recruiting. (see Overall Recruitment Status data element on ClinicalTrials.gov).

If a study requires human subjects review board approval, approval must be obtained before the study's Overall Recruitment Status is changed to Recruiting. When board approval is obtained, please update the Protocol Section of the study record in the Protocol Registration and Results System (PRS) and Release (submit) the study for processing.”

https://clinicaltrials.gov/ct2/manage-recs/faq#board