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It is a good question and I hope you get a reply from IR.
I have emailed IR on 4 occasions and only once received a boiler plate answer.
I guess I ought to read the board backwards when catching up my morning
Anyway, makes sense to me that we may soon hear of a Biogen/Anavex licensing deal.
Still there, perhaps just moved.
7th Joint ECTRIMS-ACTRIMS Meeting
25-28 October 2017
Paris, France
Scientific Programme
Friday, 27 October 2017
Parallel Sessions
14:00 – 15:30 Hall B
Parallel Session 14: Remyelination: from biology to clinical trials
P. Casaccia, New York, US
B. Zalc, Paris, FR
235 From drug screening to myelin regeneration therapies in multiple sclerosis 14:00 – 14:20
B. Nait Oumesmar, Paris, FR
236 Muscarinic receptor M3R signaling prevents efficient remyelination by
human and mouse oligodendrocyte progenitor cells
14:20 – 14:40
F. Sim, Buffalo, US
237 NFAT as a key regulator of oligodendroglial differentiation 14:40 – 14:52
K. Groll, Münster, DE
238 Sigma 1 receptor agonists as potential protective and reparative therapy in
multiple sclerosis
14:52 – 15:04
R.P. Lisak, Detroit, US
239 Single-cell RNA-sequencing profiling of oligodendrocyte lineage cells
isolated from the multiple sclerosis mouse model EAE
15:04 – 15:16
A.M. Falcao, Stockholm, SE
240 Pathological correlates of magnetization transfer ratio in multiple sclerosis 15:16 – 15:28
Let it be on record that I firmly conjecture a deal for MS between Biogen and Anavex!
No one willing to sell?
Bid/Ask ratio currently at 64%.
Which could support the idea of a Master Protocol announcement
AD trial needs PK/PD input for it's design. Much more interesting to review how PK/PD + Ariana influenced the design of a modern adaptive P2/3 trial, instead of just raw PK/PD data.
Thus my conjecture is that we will hear about the AD trial by CTAD.
If the Master Protocol conjectures has merit, maybe we will hear of all 3 trials just before CTAD. With the CTAD Poster going into the scientific detail.
But, alas yes probably the Rett trial announcement is first.
Agree, a deal is in the making. Hope they don't get bought out now. If the drug works we have something worth a lot here.
I have dead money in this since the Cortex days, so can wait longer.
I would think the trials are designed based upon the PK/PD data prior to the presentation in November and possibly also announced in October.
Ongoing in-licensing/out-licensing review to optimize value of pipeline
You may be misunderstanding my sentiment.
I am staying long exactly for the reasons you mention and because hiding bad news would only lead to more hurt for the company and Missling's reputation.
I don't just surrender to blind faith in the absence of evidence. I like to consider both the positive and not so great scenarios.
Having worked with, listened to and given many corporate presentations, I can tell and know what it feels like to present something you genuinely believe in versus something you don't. I say Missling has his heart in this venture.
Well, if Anavex is withholding not so good news, even if of a nature from trial extentions with no obligation to disclose, it will ultimately attract class action suits.
The one reason to withhold not so good info may be related to tapping LPC to have a lifeline before any announcements. On the other side of bad news the company may still be hoping to run trials designed with some prospect of meeting an end point.
I just have a hard time buying such a theory, even if I can formulate it.
"The market is an efficient mechanism for transferring wealth from the impatient to the patient." Or something like that, quote W. Buffet.
On this occasion I'd have to agree with you.
Still convinced we will get trial start news this year. Question is, would it at this stage be wise to sell some/all risking waking up to news, stay the course or switch to an options play?
Tricky, but I will stay long and have done enough AVXL swing trading along the way to be content. I don't mind if it takes a while to let this opportunity run it's course.
We got nothing from the CNS Summit, we may get nothing from Ladenburg.
At present only the same old Corporate June 2017 presentation doing the rounds...while we wait. Must be a reason for the waiting; is it as per one or more of the many conjectures here or some reason that we haven't anticipated.
I think we are back to; only time will tell...
I guess the price action is fear that AVXL will join the string of failures emphasised by AXON today.
Hard to blame the market for that and with it seems many being retail, understanding just how Anavex is different require a fair amount of insight.
The trials will start and give the pps a boost. Beyond that still a fair level of uncertainty. Noble rates chance of success at 18%.
Still long, committed and risk conscious.
Should or will?
Enrolment could drag out, but even so the trial could be halted before all participants have completed 12 weeks.
On the other hand, there has been plenty time and likely many parents belonging to Rettsyndrome.org dedicated to supporting trials and ready to enlist their child, especially for a drug that has already proven safe in humans, so enrolment may go fast.
The Rettsyndrome.org Facebook page looks quite active too discussing the Anavex trial.
Everything I am saying here i would label conjecture, but based on things we know.
I said "if, just if", which could be translated to fanciful.
Obviously, IMO it would also work the other way should the Rett trial fail it's primary end point. That is; investors would loose their confidence probably quite dramatically and for some time.
I understand your idea that Anavex ought to fill their coffer with LPC cash before any trial results are due. This way at least they would have the means to ride out the storm while hoping the next trial would work out ok.
If one believes in that thesis, buy when it drops. Likewise buy AXON now.
Scheduled to begin in 2017, the trial will be a randomized, double blind, placebo-controlled study of ANAVEX 2-73 in patients with Rett syndrome lasting up to 12 weeks
If, just if, Anavex proves successful in the short 12 week Rett trial, which could be halted early based on efficacy, can you imagine what that will do to confidence among investors in their other indications.
I did!
Would it not be reasonable to think that Anavex was awaiting the AXON results before issuing a string of positive PR?
Ouch!!
Press Release: Axovant Announces Negative Topline Results of Intepirdine Phase 3 MINDSET Trial in Alzheimer's Disease
Axovant Announces Negative Topline Results of Intepirdine Phase 3 MINDSET Trial in Alzheimer's Disease
--Conference call today at 8:00 a.m. EDT--
PR Newswire
BASEL, Switzerland, Sept. 26, 2017
BASEL, Switzerland, Sept. 26, 2017 /PRNewswire/ -- Axovant Sciences (NASDAQ: AXON) today announced that the Phase 3 MINDSET clinical trial of its investigational drug intepirdine in patients with mild to moderate Alzheimer's disease (AD) who were receiving background donepezil therapy did not meet its co-primary efficacy endpoints. At 24 weeks, patients treated with 35 mg of intepirdine did not experience improvement in cognition or in measures of activities of daily living as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and by the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL), respectively, compared to patients treated with placebo. In the study, intepirdine was generally well tolerated.
After 24 weeks of treatment, change from baseline in cognition was non-significantly improved in the intepirdine arm versus the placebo arm (0.36 ADAS-Cog points; p-value = 0.22). In addition, there was essentially no difference between the intepirdine and placebo arms in change from baseline in activities of daily living (0.09 ADCS-ADL points; p-value = 0.83). Of the endpoints analyzed to date, the only endpoint in which any significant improvement was seen in the intepirdine arm versus the placebo arm was in the first key secondary endpoint, the Clinician Interview-Based Impression of Change plus caregiver interview, or CIBIC+ (0.12 CIBIC+ points; p-value = 0.02). The Company will work with investigators to conclude the MINDSET open-label extension study.
"While we are deeply disappointed by these trial results, we also are saddened for the millions of patients and families impacted by Alzheimer's disease. However, we believe that the fight against Alzheimer's and other important areas of unmet need in neurology is too important to be derailed by this setback," said David Hung, M.D., chief executive officer of Axovant. "We are grateful to the investigators, patients and caregivers who participated in this important trial and supported us in this journey. Moreover, we remain committed to advancing our pipeline, which includes our Phase 2b HEADWAY study of intepirdine, and nelotanserin, our highly selective inverse agonist of the 5-HT(2A) receptor in Phase 2 development, both of which are being evaluated in patients with dementia with Lewy bodies."
The HEADWAY trial studying intepirdine in patients with dementia with Lewy bodies (DLB) remains on track to report topline results at the end of 2017. This study investigates two doses of intepirdine, 35 mg (the dose used in the MINDSET trial) and 70 mg, a higher dose intended to engage both 5-HT(6) and 5-HT(2A) receptors. Intepirdine has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of DLB.
IMO everything points towards Missling following the path he has declared.
Rett first as the shortest route to market. Prescreening is in progress, Rettsyndrome.org has verified it (thanks Talon) and thus in all likelihood the actual trial will start this year with readout early 2018.
My guess is that tomorrow's presentation at minimum will be clearer on the status of the Rett trial and perhaps on the other two expected trials as well.
That being the case I venture a guess that the presentation will also include a tick in the PK/PD info box.
Risking these guesses here just in case I might right once in a while, but please don't base any investment decisions on it.
Yes, but only temporarily.
"We know Pfizer is knocking at the door"
'We hope and conjecture that Pfizer is knocking at the door' - sounds more accurate to me, or did I miss a PR?
The study is valuable and proper science, which will help to either disprove or perhaps highlight facets of amyloid beta build-up that can lead to delay in or prevention of Alzheimer's onset and progression.
Perhaps Anavex is in with a chance to short circuit the route to a better SOC treatment, but we don't know yet and can't expect the rest science to stand still.
Press Release: Biogen Appoints Camille Lee as SVP, Alzheimer's Disease Therapeutic Area
Biogen Appoints Camille Lee as SVP, Alzheimer's Disease Therapeutic Area
CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 25, 2017--
Biogen (NASDAQ: BIIB) announced the appointment of Camille Lee as Senior Vice President, Alzheimer's Therapeutic Area, effective today.
In her new role, Ms. Lee will be responsible for the design and execution of commercial strategy for the company's late-stage Alzheimer's disease assets and will work in partnership with Biogen's Research & Development function in overseeing Biogen's entire Alzheimer's portfolio. She will be based in Cambridge, Mass., and report directly to Chief Medical Officer Alfred Sandrock, Jr., M.D., Ph.D.
Ms. Lee brings to Biogen more than 30 years of industry experience. In her most recent role as Senior Vice President, Diabetes & Obesity Marketing at Novo Nordisk, she led a team of more than 500 professionals while overseeing the marketing of all in-line and future brands as well as market access strategy. During her time in this position, Novo Nordisk successfully launched two brands that achieved leadership in their therapeutic areas.
"Camille's experience in preparing markets and launching products for highly prevalent diseases will serve us well as we aspire to move toward commercializing our late-stage Alzheimer's disease candidates," said Dr. Sandrock. "Her track record aligns perfectly with our mission to deliver transformative therapies for neurodegenerative diseases to patients who desperately need them."
Prior to taking a leadership role for Novo Nordisk's diabetes and obesity franchises, Ms. Lee worked across the organization. Her tenure at Novo Nordisk included positions of increasing responsibility in such functions as competitor intelligence, product launch planning, and international marketing for multiple endocrine products.
"Biogen's R&D in Alzheimer's is an inspiration, and I am honored to be joining a company that has such an unwavering commitment to the community," said Ms. Lee. "I look forward to working with the team as we aim to bring therapies to the market that could make a difference to the thousands of patients and their families that we serve."
Ms. Lee holds a B.S. in Business Administration from California State University, Long Beach, and an M.B.A. from Copenhagen International Management Institute.
Actually I am just kidding to humour you. I won't sell even if no news tomorrow, but I won't like it as much as news long overdue.
Perhaps, any theories on what purpose Missling would have in mind with going on the podium to present same'ole?
If he does, I will seriously consider joining the shorts.
Calcium homoeostasis.
I recall reading that the cellular homoeostasis referred to by Anavex, is more specifically calcium homoeostasis. It turns out I read that back in February in the research report from Noble, thanks TTTav66!
http://nobleresearch.com/reports/AVXL_20170206_9669.pdf
I have no biology or medicine background (Electrical Engineering & Computer Scinence), but am inquisitive and enjoy science of all kinds. So hope someone here can elucidate.
As I understand there must be many ways in which cells can be out out balance and it strikes me that claiming 'cellular homoeostasis' seems too broad a statement, if in fact A2-73 more specifically helps restore 'calcium homoeostasis'?
Do we know that Alzheimer's and other indications targeted by A2-73 only manifest calcium imbalance?
If other cellular mechanisms are also out of balance, which might they be and what adjunct treatments known or being researched might provide something closer to complete cellular homoeostasis?
Hope this makes some sense?
The website may not be their focus, but it does give a bad impression.
Hadn't seen it before, very promising.
Yes the article helps frame slide 33, thanks.
Lol, MacFarlane looks much younger and happier in the article picture - has he been pilfering a little A2-73 for himself.
That helps and would have been a great footnote for slide 33.
Only 1 patient had a score improvement for 'Guilt'. Likewise, does than mean no one else experienced feelings of guilt or just did not improve or get worse on that score?
http://serene.me.uk/tests/ham-d.pdf
The test consists of 20 questions rated by the interviewer on a scale of either 0-2 or 0-4 depending on the nature of the question.
One must assume all 20 questions were rated for all patients (n=25?) apparently to be repeated weekly. Or was only the questions related to slide 33 examined on some notion that these would be the only questions of interest?
We just cannot tell from the data. How was the before and after scoring done to determine improvements or not? E.g. was the criteria for inclusion in slide 33 simply only improvements, while ignoring the 11 other questions the answer to which would have been same or worse?
Was it the first of each scoring session subtracted from the last or was the difference in before and after score somehow worked out across multiple weekly interviews?
I would assume that only the 9 of 20 questions on slide 33 had improvements. The others same or worse.
Hard to say how significant these result are, but at a non-critical glance it looks convincing, at least for insomnia.
Ps! Doubt very much Missling had anything to do with those AH trades.
My trading / info terminal agrees with Nasdaq. Odd if you see fewer trades. More might be understandable if your broker shows off market trades.