Anavex Life Sciences Corp (AVXL)

[drv17]

Investor, that was mean of you to refer me to that document this morning. It was too much for my poor old addled brain to comprehend with all of the "whereases and here-to-fores" of lawyer speak.

It appears to me that since this is an "Interventional Study" that any financial interest would be irrelevant. Furthermore, I did not see where the FDA prohibits any financial interest of a PI but rather just wants them fully disclosed.

From https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm341008.pdf

A.2. Q: What is the purpose of FDA’s review of clinical investigator financial disclosure information and how can sponsors minimize bias? A: FDA’s review of clinical investigator financial disclosure information alerts FDA staff to financial interests and arrangements that could lead to bias in covered clinical studies. The financial disclosure process also provides FDA with information regarding whether and to what extent the sponsors have taken steps to minimize the risk of bias. An important means of minimizing the potential for bias resulting from such financial interests and arrangements is through proper study design (see 21 CFR § 54.5(b)). For example, using randomization and blinding helps to minimize the potential for bias in assigning subjects to receive the test article or placebo and in assessing study outcomes and analyzing results. Similarly, having someone with no financial interests or arrangements evaluate study endpoints, especially in an unblinded study, can help minimize potential bias in assessing therapy outcomes. FDA staff consider the financial disclosure information and the methods the sponsor used to minimize bias during the review of marketing applications to assess the reliability of the clinical data (see 21 CFR § 54.1). Additionally, because sponsors of studies conducted under INDs and IDEs are required to collect financial information from clinical investigators prior to study initiation,7 sponsors can work with FDA to minimize any potential bias. FDA strongly encourages sponsors of studies not conducted under an IND/IDE to collect financial information prior to study initiation for the same reasons.

From https://clinicaltrials.gov/ct2/show/NCT03758924

Descriptive Information
Brief Title ICMJE Study of ANAVEX2-73 in Patients With Rett Syndrome
Official Title ICMJE A Double-Blind, Randomized, Placebo-Controlled, Dose Titration Study of ANAVEX2-73 in Patients With Rett Syndrome
Brief Summary
Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study.

7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.

Detailed Description
This Phase 2 safety, tolerability and efficacy study is designed as a double-blind, randomized, placebo-controlled study.

This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years or older. A voluntary option will be offered for all patients who meet the exposure criteria for ANAVEX2-73 to continue a 12-week open label extension.

Study Type ICMJE Interventional
Study Phase Phase 2
Study Design ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-Blind, Randomized, Placebo-Controlled
Primary Purpose: Treatment
Condition ICMJE Rett Syndrome