Replies to post #177590 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Let’s hope that holds for P2. For any pivotal study leading to filing an NDA I don’t think it looks good that the PI is also the CMO and an officer of the sponsor.

[Doc328]

Every investigator and sub-investigator must fill out a COI questionnaire before every study and must update if a conflict develops while their role in the study continues. If an investigator has a conflict, a plan must be developed to reduce the conflict for every step (recruitment, study visits, data analysis, etc) and multiple disclosures of the conflict must be reported.


In filling out these forms, a spouse's or a child's conflict counts as your conflict. There are about 5-6 questions and they are pretty standard. I fill out several every years as site PI or sub-I. The questionnaire asks if you (or close relative or company you have an interest in, etc.) receive payments (not counting direct research payments for patient related activities for that particular study) or salary > $25,000 or if you have an equity interest in the particular company or any competing company (conflicts go both ways) >$25,000. I believe the threshold is $10,000 if any NIH money is involved. If the outcome may lead to you profiting in the future, you must also disclose.


Therefore, Kaufmann definitely has a conflict. He could continue as a PI but multiple steps must then occur. A plan must be developed to reduce the COI. The specific COI and plan must be disclosed to the FDA and to the IRB (and if he maintains any relationship to Emory he would need to also disclose to them --- and probably to Rett society since they have partially funded). The fact a conflict exists must be disclosed on the ICF forms signed by patients (and caregivers). The IRB will report back if the plan is insufficient and the FDA would take these COI and the plan into consideration after the NDA is submitted. Therefore, studies are much easier and have lower future regulatory risk if the COI is eliminated rather than worked around. I suspect another investigator will replace him as study PI -- this is really not a big deal to do, especially in a smaller study.


Personally, I have never had a formal conflict and have never invested in a company while I am involved in a study (though I have SPY, IWM, etc and they may hold shares but proportionate value would be < threshold).