Anavex Life Sciences Corp (AVXL)

[nidan7500]

AVXL has presented a very powerful set of results on risk. (the Dr.M. claim of low/no risks). There fore much of the spending and efforts typically required by NDA have been mitigated through trial results to this point. Hence, beliefs by some here (including me) are that A2-73 can be moved more quickly than otherwise might be possible.
https://drug-dev.com/fdas-quality-risk-management-approach-to-new-drug-applications/

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The FDA’s QbD guidances provide essential elements for design controls from product development to the commercial manufacturing processes and for post-development changes in the drug molecules as effective as possible. The QbD approach can be maintained throughout the life cycle of the product in order to facilitate continuous quality improvement (CQI) in the final outcome of the drug product (Figure 1). In contrast, previous traditional pharmaceutical manufacturing relied heavily on end product testing, and the process typically lacked the flexibility needed to respond to variables encountered during manufacturing processes. The application of HACCP quality risk analysis approach identifies CCPs in the manufacturing process that require control monitoring because of detection of out-of-limits or drifts when they occur.2,6 The HACCP management system provides a focus on the CCPs most likely to control product safety. This approach allows FDA reviewers and investigators to evaluate and verify that significant drug product safety hazards are properly identified and the appropriate controls are in place.

CONCLUSION

The FDA’s mission is to facilitate the premarket review and evaluation of INDs and NDAs. A central theme over the past few years has been a standardized approach to evidence-based review and evaluation. The FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.