Anavex Life Sciences Corp (AVXL)

[XenaLives]

So the TGA is working closely with Health Canada per the replied to post.

That means that they will have access to McGill researchers and their data.

It also means that Canada will have access to Australia's data.

The question that arises is:

Will Canada also give Anavex conditional approval if Australia does?

1.1 Policy Objective
The objective of the Notice of Compliance with Conditions policy is to:

1)provide access to promising new drugs for patients suffering from serious, life-threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or for which a significant increase in efficacy or a significant decrease in risk is demonstrated in relation to an existing drug marketed in Canada;
create mechanisms for the appropriate completion of confirmatory trials to verify the clinical benefit of a drug authorized under this policy; and
2)ensure transparency of the conditions associated with the market authorization.

The benefits of the NOC/c policy are twofold:

It facilitates earlier access to the drug by physicians and patients. The acceptance of promising evidence of clinical effectiveness allows for the filing of an eligible drug submission earlier than normally possible. Should the outcome of the review be positive, the time to approval and market for the drug may be shortened. It should be noted that the time to agreement on the acceptability of the contents of the "Letter of Undertaking" will affect the overall time to market.
It provides the means to effectively monitor, and report on, the safety and efficacy of promising new therapies through enhanced post-market surveillance initiatives.
1.2 Policy Statement
A Notice of Compliance issued under the NOC/c policy may be granted for a drug product with promising clinical benefit, providing that it possesses an acceptable safety profile based on a benefit/risk assessment, and is found to be of high quality.


....

1.3 Scope and Application
The Notice of Compliance with Conditions policy applies to:

NDS and SNDSs for a serious, life-threatening or severely debilitating disease or condition for which there is promising evidence of clinical effectiveness based on the available data that the drug has the potential to provide:
1)effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in CanadaFootnote 2; or
a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.
2)ANDS and SANDS in instances where the Canadian Reference Product still holds the NOC/c status.
In all cases, a prerequisite for issuance of an NOC, qualifying under the NOC/c policy, will be the sponsor's written commitment to pursue undertakings acceptable to Health Canada.

As with similar programs in other international jurisdictions, the NOC/c designation applies to the product's specific indication being studied, and not the drug product alone.

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html