Anavex Life Sciences Corp (AVXL)

[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

Thanks F1ash. I still think AVXL's hold up is with the FDA and even if they can register on clinicaltrials they want to wait until they have a finalized protocol. The above refers to an IRB approval (or equivalent) which they probably already have and I believe is easier to get than FDA blessing. Either way, I'd think they would be hesitant to list on clinicaltrials before they have a finalized protocol. If they listed now would they be forced to list as "recruiting"?...I'd think yes. It all seems very convoluted and a major mystery (to me) as to why this has not all cleared up by now. At least one person is able to share the reason (Missling) and he has chosen not to. Can't say that bodes well but at the same time I'm not sure why this is so difficult.