Anavex Life Sciences Corp (AVXL)

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Some data from an article Jeffery Cummings wrote found throught your link when “anavex” was used in the search bar. Some items we may look forward to.

“Phase III
Phase II and Phase III are often conceived as “learn” and “confirm” trials [55]. The learnings of Phase II are tested in Phase III and, if benefits are confirmed, the agent will be submitted to the FDA for review. Phase III trials for DMTs are 12 to 24 months in duration and typically involve 600–1000 patients per arm of the study (each dose and the placebo comprise 1 arm each). The reasons for failure of drugs to advance from Phase III to regulatory review include lack of efficacy (50%), unacceptable toxicity (14%), and commercial, strategic, and operational issues (31%) [56]. These figures are for all classes of agents (not limited to AD-directed drugs); they emphasize the importance of accruing efficacy data in Phase II. Drugs that have genetic connections to the neurobiology of the disease and that have biomarkers to inform drug development decisions are more likely to advance from one phase to the next than drugs that lack this information [57].
As noted above, biomarkers are used in Phase III to diagnose participants, support disease-modifying activity, and monitor amyloid-related imaging abnormalities in mAb studies”

And this explains a bit on where we have been. Apologize for the organization as I am doing this from my phone.

“Adaptive clinical trial designs use data from the on-going trial to make decisions about trial conduct. For example, the Dominantly Inherited AD-Treatment Unit (DIAN-TU) uses an adaptive strategy for dose-selection of test agents [84]. Adaptive strategies can be used for dose, treatment duration, sample size, and entry criteria. The decision structure must be comprehensively pre-specified but adaptive designs have the advantage of responding to the in-trial observations and can save time and resources while optimizing the opportunity to demonstrate a drug-placebo difference [85].
Another resource-saving strategy in clinical trial design and analysis is the incorporation of futility analyses at a time when a sufficient number of patients have been exposed to treatment for a sufficiently long period time to predict the possible outcomes. If the drug-placebo difference at the time of the analysis suggests that the study has a very low possibility of finding a drug-placebo difference at trial conclusion, the trial can be stopped [64, 86].”


https://content.iospress.com/articles/journal-of-alzheimers-disease/jad179901

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