Replies to post #369827 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

We did notice in all three indications that S1R shows up in two different genetic forms (WT [80-90%] vs. mutation) and WT had better results. With high enough dosing however, there is not much difference between WT and mutation.

Good luck and GOD bless,

[plexrec]

" super excited about the bolded "--thanks Mayo for this "outstanding" post !!!!!

[falconer66a]

Thanks for this posting.

I found this Missling statement of particular interest:

...we have adequate manufacturing and supply in place for a rollout assuming approval and commercialization....

I believe this is further substantiation of the ease of blarcamesine synthesis; meaning that it can be and may already have been farmed out to a drug supply contractor. Daily 50mg doses won't be expensive to manufacture; works to the benefit of the company, its shareholders, and patients. All-win.

All of the other presented information is positive. Read the material with scrutiny. The Anavex story continues to develop so positively. Great things in the (near) future.

[RedShoulder]

Many thanks Mayo for the notes, very helpful.

I especially like the parts you bolded:

"Additionally I'd like to make mention that we have adequate manufacturing and supply in place for a rollout assuming approval and commercialization"

Q: Can you speak to the imaging use of Blarcamesine vs. therapeutic use at a commercialization level? Also, how are you thinking of optimizing the value of Blarcamesine in U.S. territories. Can we talk about partnerships? Please also add context regarding IP protection in places such as China?

A: We did notice in all three indications that S1R shows up in two different genetic forms (WT [80-90%] vs. mutation) and WT had better results. With high enough dosing however, there is not much difference between WT and mutation. We are in parallel developing a diagnostic test in order to go into the market with the ability to identify WT-gene patients if necessary. We will see if the AD and EXCELLENCE study will require such a selection. It may be that there is enough benefit in both S1R-gene groups that we don’t need such a diagnostic but will have it just in case. We are planning on marketing Rett syndrome and possibly Fragile-X ourselves. We are in discussions with European, Asian, and Chinese companies to market outside the U.S. We are also looking at global partnerships and regional partnership opportunities. We ARE in discussions for this already for a worldwide roll-out. We have filed patents to become aggressive with protection in China – always including protection in the U.S., Europe, and Asia, with specifically in China.

[jmvho]

Many thanks Mayo !!

jmvho

[gbrown6332]

Very nice job on your summation of the call. More concise than the actual call.

Improved Q&A too.

[xodcode]

Mayo, thanks for distilling CC content.

Yes, very exciting times await AVXL shareholders. Very nice to know that AVXL already has abundant A2-73 supply for the near term needs! (Manufacturing costs are minimal).

[Hoskuld]

Thank you Mayo!

[Jonjones325]

Thanks Mayo!!

Some here were speculating on the utility of the gene cluster data saying that it could be used as a way to select patients. I think an analyst even asked the question but Missling didn’t catch it.

It seems to me Missling just wanted to re-confirm our MOA and that it’s actually causing changes at this level. It also seems to me that Missling feels like he doesn’t need to do trials with a specific selected pool of patients. Otherwise he would have mentioned the data’s utility in doing WGT trials.

It speaks to Missling’s confidence level in our MOA. Also, Misslings statement about how the variant sigma one patients do just as well when at a higher dose was intriguing. He would only know this by seeing a healthy response from those patients. Whether it’s in the OLE or not, it gives a good clue that he is seeing effect.

Are the patients titrated to their highest tolerable dose in the OLE or do they remain on the same trial dosage? Anyone?


“The most important take away was that the drug has the ability to resuscitate/counter downregulated pathways and clusters of gene pathways which are downregulated in AD/PD. We showed the broad ability to counter these complex pathologies – evidence that Blarcamesine can target the disease independent of a patient’s unique pathology. Patients with higher S1R activation continuously see the greatest therapeutic benefit.”


More evidence, proof that our drug does what we say it does.

[Gator328]

Thanks for sharing. I believe the mystery indication is ALS based on Dr. Missling's comments.

[tredenwater2]

Outstanding Mayo. I was quickly scrolling down for a boiled down overview and as always I new I could trust your opinions.

Thank you

#WGT!