Replies to post #249892 on Anavex Life Sciences Corp (AVXL)

[JWC3]

Thanks Bio, nice info!

[plexrec]

Bio--"Anavex’s drug approved for treating 3 types of CNS"--excellent "dot-connecting" and analysis---again-kudo's to you !!! Food for thought!!!!!!

[Doc328]

Knowing the current and future competitive landscape is important for Biotech investing. When "Dr. Missling mentioned at the ASM that we are doing a PDD trial with similar endpoints as Lilly" do you think he meant an oncology drug?

Another possibility (maybe even 100% certainty) is that he meant LY3154207. This is a Lilly drug that just completed enrollment for PDD and has similar inclusion and exclusion criteria and the identical primary endpoint and many of the same secondary endpoints. MOA is different than A273. Lilly calls this a phase 2 but there are > 300 patients in the study. They changed the clinicaltrials.gov status to not recruiting in April so LPLV will be in July and Lilly should have results by October.

[sokol]

Bio: Brilliant research and analysis. I never would have made all of the connections, including the statement by Missling about being in good company with Lilly. You demonstrae too that Missling knows what he is doing although we sometimes have difficulity appreciating the progress Anavex has made under his leadership. Anavex’s progress, financially and clinically, has been gradual. However, I suspect we will see things pick up from here on now that Anavex has established sources of funding for completing existing trials and to add future trials. We will have four clinical trials in play in 2020, and I think more to come.


Additionally, below I cite findings that drug targets with genetic support are more likely to be approved. Here is the article:


Are drug targets with genetic support twice as likely to be approved? Revised estimates of the impact of genetic support for drug mechanisms on the probability of drug approval.
Emily A. King1*, J. Wade Davis1 & Jacob F. Degner1 1AbbVie Genomics Research Center, North Chicago, IL. January 7, 2019

"Analyzing historical pipeline data, Nelson et al. 2015 (Nat. Genet.) concluded pipeline drug targets with human genetic evidence of disease association are twice as likely to lead to approved drugs. Taking advantage of recent clinical development advances and rapid growth in GWAS datasets, we extend the original work using updated data, test whether genetic evidence predicts future successes and introduce statistical models adjusting for target and indication-level properties. Our work confirms drugs with genetically supported targets were more likely to be successful in Phases II and III. When causal genes are clear (Mendelian traits and GWAS associations linked to coding variants), we find the use of human genetic evidence increases approval from Phase I by greater than two-fold, and, for Mendelian associations, the positive association holds prospectively. Our findings suggest investments into genomics and genetics are likely to be beneficial to companies deploying this strategy"


https://www.biorxiv.org/content/biorxiv/early/2019/01/08/513945.full.pdf


Going forward, I believe we will see more and faster developments. Using a quote from someone: “There are decades when nothing happens, and weeks when decades happen,”

Thank you.

[nidan7500]

Totally agree w/you on links to Oncology (PM) and the thinking presented by AVXL, Particularly after the recent HH AI paper and our "Consortium" . Lots of dots out there these days.

This third paragraph is in parallel to what we are doing.
“Lilly's drug is part of a trend of treating cancer based on a patient's genetics rather than the location in the body where the disease originated.”

So, if we can see in print, “Lilly’s drug approved for treating 3 types of tumors”,
we should not be surprised to read some day that “Anavex’s drug approved for treating 3 types of CNS diseases.”

FDA approves Eli Lilly drug to treat three types of tumors https://seekingalpha.com/news/3572368

[powerwalker]

Hello, Bio. Thanks again for your insight and thoughtful analysis.

Question for you and others: If AI were being used for PDD analysis of trial data and the subsequent OLE, why would it take so long (8 weeks or more) to complete the analysis and reveal the results? Seems to me, that AI's computer power (processing 24/7, too) would knock that out in two weeks at most and another two weeks of human review.

Just asking ...

P.S. Happy Mother's Day to one and all!


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