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Dr Tanzi also organized last December's NYAS Alzheimer's symposium, Alternatives to Amyloid, along with Nell Rebowe, at which both he and Missling gave presentations. Dr. Tanzi is well aware of Anavex and appears to have a good rapport with Dr. Missling, as the two men sat together during the presentations, commenting amongst each other throughout. Dr. Tanzi was also one of 2 people who posed questions to Missling during his Q&A.
The position advertised last fall was for an AD/Director of Clinical Operations. That job ad was taken down after a couple months, and I believe the position was filled by Jordan Press, who has been listed as Senior Manager, Clinical Operations on LinkedIn since January.
Well said, jimmy — I couldn't agree with you more here. I am encouraged to see him continue to grow in his role as thought leader for these advances, spreading the knowledge on these key stages.
I will happily pass along your message of thanks tomorrow. Cheers.
June 25th, Christopher Missling, Mohammad Afshar (CEO of Ariana Pharma), and Federico Goodsaid (Principal of Regulatory Pathfinders), will come together as panel participants at the DIA 2019 Global Annual Meeting to share their knowledge in a session entitled, Artificial Intelligence Enhanced Data Analytics for Clinical Trials.
Dr. Missling's comment on this from last year's meeting:
Dr. Missing and the entire team fielded any and every question posed to them last year (to the extent of their ability to disclose), both during the formal remarks and before/after the official meeting. There was no shying away from questions from those who participated. I'm sorry you were unable to attend so you could speak on this matter with any level of accuracy.
Thanks for the link and for pointing that out. I'm wondering if the gut microbiota data will be presented at AAIC in July. Submitted program notifications for general abstract submissions were sent out to the presenting authors on 3/25, so timing of this announcement would make sense.
They've given a presentation with this exact same title at several conferences now, with the first time being at CTAD last year where the 148-week data was originally presented: https://www.ctad-alzheimer.com/files/files/Late%20breaker%20oral%20communications.pdf
Anavex is returning to the 2nd Annual Neuropsychiatric Drug Development Summit from July 23-25 in Boston.
On July 23, Dr. Missling will lead 1 of 3 pre-conference workshops; Reviewing the Potential for Precision Medicine in Neurological Diseases.
On July 25, he will also be featured in a 2-person panel with Sean Smith, the Executive Director of Neuroscience Discovery at Merck; Panel Discussion: The Precision Medicine Approach to Neuropsychiatry – For or Against?
Download the Full Event Guide at the website below for further details:
https://npd-summit.com/
Thanks for posting this — looking forward to watching.
Exactly.
Please see the edit to my previous post. Unsure why you would object to this.
Fairly obvious seeing that it was in the "Press Area" of the site. Intention would be to raise awareness of the trial and boost recruitment. Seems prudent to me.
Soon to be published mini review article by the team at McGill University who have previously conducted and published pre-clinical work on Anavex 3-71 (AF710B):
https://www.frontiersin.org/articles/10.3389/fphar.2019.00189/full?fbclid=IwAR1K40Lx1AP1bRGrrGlcoiKvELDMmYBqEv79SxWs89XBdlMHVqdhgCi4rE4
From Gaceta Médica, "the leading newspaper in health and health information in Spain":
Good call Xena — They've been using BDO's audit services for at least the past 6 years. I stopped checking 10K's after that.
Note, authorization of the preferred shares was not up for vote last year, but they were in 2017.
I made no leap, nor any mention of trial sponsorship in my post. My post was only intended to address the direct quote, and review the current known information. My statement that this is "the first substantive acknowledgement of a continuation of this partnership beyond the pre-clinical funding" should not be read any further than encompassing the stated collaborative decision to shift the P2 trial focus to a PDD indication.
That said, I am still curious if there is more to the relationship, but will not be drawing any conclusions until further facts present themselves.
That makes sense McMagyar, and I didn't mean to make it seem that you hadn't taken this into account. I am fully in favor of the board's recommendation to authorize the preferred shares, and I'm intrigued by your theory of this possible usage of the shares. Cheers man.
I noted that they are listed as a "partner" on that site in my post, not a sponsor though.
On the topic of the Michael J. Fox Foundation, I've been wondering about their continued commitment to the development of 2-73, since there hasn't really been further mention of their involvement beyond the pre-clinical funding which Anavex continues to tout in each press release. We do know, though, that the MJFF has been listed as a "partner" on Anavex's pddtrial.com recruitment website, but that in itself doesn't provide much further clarity.
Amidst the ludicrous discussions about Dr. Missling's physical appearance in the recent Bio CEO & Investor Conference interview, one thing I haven’t seen discussed is that Missling make mention here of further coordination with the MJFF. To my knowledge, his statement that the MJFF was involved in the decision to focus the Phase 2 trial on Parkinson’s Disease Dementia is the first substantive acknowledgement of a continuation of this partnership beyond the pre-clinical funding.
Full quote starting at about the 1:06 mark :
Dr. Missling interview from the Bio CEO & Investor Conference
A bit of dd that may add to the speculation of planned timing to commercialization:
Rocio Garcia Canamaq, the founder of Leon Research—Anavex’s CRO for the phase 2 PDD trial in Spain—has been hired to be Anavex’s QPPV as of January per her LinkedIn profile. What’s a QPPV? From Wikipedia:
Exactly the info I was looking for. Many thanks and have a good night!
Biostockclub -- one question on the timing here; this patent looks like it was originally applied for internationally 2 years prior to this current publishing, on 1/24/17. Here's the link to the original application:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2017132127&tab=PCTBIBLIO&maxRec=1000
What does this mean for this current "published" stage of the patent process? From the link above, if you click on the "National Phase" tab, you get some dates indicating that this was published on 5/28/18 with the European patent office, and lists the latest date, 1/24/19, for US publishing. It also indicates that the patent has been applied for in Canada and Japan.
Interestingly, in the original application they also listed Anavex 1-41 and it's active metabolite within the patent description, but at some point they must have chosen to focus on 2-73 which makes sense. Otherwise, the current patent description and claims seem to be much the same as they were in 2017.
Anyhow, I have to admit, that no matter how much DD I've done here, the patent process remains a bit cloudy to me. Any further thoughts on the application dates vs publishing dates and international vs national standing would be much appreciated.
Thanks!
Patent news? Unsure if this was posted here before, but this patent has a 1/24/19 publication date. Thoughts?
https://patentscope.wipo.int/search/en/detail.jsf?docId=US236451262&tab=NATIONALBIBLIO&office=&prevFilter=%26fq%3DICF_M%3A%22A61K%22&sortOption=Pub+Date+Desc&queryString=&recNum=213&maxRec=2035248
Makes perfect sense. I misread the title. Thanks again!
One thing to note is that Federico Goodsaid has been working with Anavex for some time now. He was listed as an author on presentations given by Anavex at both AAIC and CTAD last year. As you've pointed out, his credentials and connections are top notch, and I personally find it very encouraging that he will, as an independent entity, be speaking to his work with Anavex at this Grodon Research Conference.
Thanks for keeping the running update. First link is to a past event, though, and here are 2 other upcoming ones:
Feb. 11-12 : BIO CEO & Investor Conference
Participating Company: https://www.bio.org/events/bio-ceo-investor-conference/companies
March 18, 2019 : Oxidative Stress and Disease Gordon Research Conference
Presentation: "Anavex 2-73 Patient Selection Biomarkers for Precision Medicine in Alzheimer's Disease" - Federico Goodsaid of Regulatory Pathfinders
https://www.grc.org/oxidative-stress-and-disease-conference/2019/
Adding onto the topic of external collaborators touting their work with Anavex, Federico Goodsaid of Regulatory Pathfinders, will be giving a presentation, Anavex 2-73 Patient Selection Biomarkers for Precision Medicine in Alzheimer's Disease, on March 18th at the Oxidative Stress and Disease, Gordon Research Conference; Redox Biology and Disease: From Integrated Omics to Interventions.
https://www.grc.org/oxidative-stress-and-disease-conference/2019/
This may be the article you were looking for? http://www.pharmexec.com/site-activation-key-more-efficient-clinical-trials?pageID=1
Thanks Investor for keeping us updated here. I believe your timeline projections are very reasonable. An interesting thing to note is that as the status of the sites are updated, all of the dates listed for their activations fall in September or earlier (going all the way back to June). Conceivably, there is a delay in these updates, and all sites may already be up and running (and for some time now).
Daniel Klamer will present a webinar, Precision Medicine in CNS Drug Development, on December 13th: https://resources.sharevault.com/webinar_precision-medicine-in-cns-drug-development
Some CTAD coverage:
On Nov 10th, Dr. Harald Hampel will be presenting at the 16th Asian Oceanian Congress of Neurology (AOCN) - Coex, Seoul Korea
For the first time in awhile, Anavex has listed an upcoming event on their Event's page: https://www.anavex.com/investor-material/events/
I've posted about this one-day symposium previously, but as a reminder:
Here's a link to the October Corporate Presentation used at the Cantor Fitzgerald Conference. I don't believe this has been posted here before and I don't think there is an easily accessible link on the website:
https://www.anavex.com/wp-content/uploads/2018/10/Anavex-Presentation-Oct-2018.pdf?fbclid=IwAR0iuMaM5d8qTNM9UJN-RjwJbfHHGAYQP1Htm70enLmj7Z15p61yDgA9SI0
Another article by Ariana Pharma on their website, this time highlighting the CTAD presentation:
http://www.arianapharma.com/2018/10/arianas-ai-demonstrate-clinical-efficacy-of-anavex2-73-for-alzheimers-patient-ctad-2018/?utm_source=linkedin&utm_medium=post