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They say "might," because that's the correct terminology here, since they did an in vitro study looking at OPC maturation to OLs and haven't confirmed that remyelination occurs in vivo (in mice/humans) yet. This is how scientific information is correctly disseminated.
Wall Street Whispers blogspot page has been taken down. Not sure if this has been posted yet, but can't believe people fell for the fake BO rumors.
Biogen is still pushing an awful drug for AD that they know barely works, yet some people on this board think that Biogen may have thrown in the towel with regards to a therapy for MS - their golden ticket therapeutic area which is now at risk due to Roche's new MS drug - which Anavex has already shown in some preclinical work to be efficacious for MS, that Biogen is now validating further. Crazy to think that rejecting 2-73 is the predominant possibility and not the possibility that a partnership with Biogen is possible.
I agree with basparks. It's strange that they did not present at AAIC, and combined with other deafening quietness, it seems like something is brewing.
This post is so misguided. Of course Biogen wants to see a placebo-controlled trial...but you don't really do that until Phase 2B but more importantly Phase 3. BP doesn't necessarily want to see that, in fact they may want to be the ones who actually CONTROL the placebo-controlled trials, especially if they have the resources for it AND if they can get the company for much cheaper by grabbing it in Phase 1/2 stages. And what's your point about 10 months? Clearly you haven't done in vivo animal experiments, which the PR stated was going to be the next step after in vitro OPC differentation assays, and these experiments can take a long time. Even just breeding the animals to get the correct animal phenotype takes months, not to mention the time of the actual experiment.
We should all be wary of rhetoric that uses absolutes like "zero possibility." Anyone who pretends to know exactly what the company is doing, in absolutes, is scamming here.
Actually that was presented in May: http://www.anavex.com/my_uploads/Anavex-Angelman-FX-Rett-conference-update-2017-May-2017-final.pdf
Don't forget that it takes time to recruit patients and screen them. Granted, it may be easier to recruit Rett patients, but just wanted to add that in there in case people really think that the entire trial takes only 12 weeks. That's just the treatment period. There is usually also a follow up period as well.
Ariana's analytics as well as PK/PD modeling are strictly happening in order to drive the best Ph2/3 study design in order to get the best results in the actual Ph 2/3 trial. This is what other companies and clinical trials have failed to do in the past, and thus it is an admiral approach. Additionally, it makes me laugh to see that people feel entitled to the PK/PD data. Missling says it will be reported when available, so all the conspiracy theories and fear-mongering comments about whether or not the data is good is useless.
That wasn't my question. My question was regarding his/her opinion on what the market expects for PK/PD data. I'm asking to lead to my next point which would be that I don't think most people even understand what PK/PD data is even used for.
I'm curious to know what part of the abstract shows that 2-73 was the "least effective agonist" in the study. This was a mechanism of action study further delineate the MOA, it wasn't to test for efficacy. Just because one agonist might reduce ROS slightly more than others, it doesn't mean it will necessarily perform the same efficacy-wise in humans, as many of these drugs have multiple targets and MOAs.
Isn't this a list of customers anyways? I don't really view us as a customer, but a collaborator.
These BACE inhibitors don't really stand a chance, in my opinion. BACE1 is an enzyme that cleaves many proteins, and you can imagine that long term/chronic administration of this drug may lead to unnecessary cleavage of many proteins. In fact, Lilly's BACE1 inhibitor has been shown in animals to result in the accumulation of uncleaved proteins, including an important one called "neuregulin 1" which is involved in the myelination of nerve axons, and therefore you can impaired myelination. Yeah, that's bad, even though it's only in animals. You don't really want to replace one bad neurological/cognitive condition with another one or multiple others, especially not with the FDA looking over your shoulder constantly.
Wow, guys, Merck's EPOCH trial was halted, because it was shown to not be helping Alzheimer's patients...
These BACE inhibitors were going to be the next big thing in Alzheimer's, at least that's where Big Pharma was heading in terms of clinical development for AD. Besides Merck, Eli Lilly/Astra Zeneca are working on another BACE inhibitor and so is Biogen/Elsai, but this makes me think that those trials won't pan out as well...
Well, the reason 2-73 was further along is because Anavex did not license 3-71 from another company until March of 2014. Anavex had 2-73 for much longer, and it's not that they had both compounds and just started investigating one earlier than the other. This is the PR: http://www.anavex.com/anavex-strengthens-alzheimers-pipeline-obtains-exclusive-worldwide-rights-to-intellectual-property/
FYI, Anavex presented preclinical MS data at ACTRIMS 2016 conference last year in Feb. 2 days before the event, they PRed that they would be presenting data. ACTRIMS 2017 is occurring in Feb this year, and I wonder if there will be an abstract...
LOL I know right? I would love to have the SEC call me...they may never want to call me again after that.
The experiment itself shouldn't take longer than 2 months, but the timing of data release depends on how long the experiment actually took (i.e. did they already have cells in culture, or did they have to start from frozen, things like this can affect how long the experiment actually takes overall), when did they actually start the experiment (was it the day the MTA was announced, or possibly before or maybe months after), and lastly, maybe they already have the data and just haven't announced anything yet (not sure they have to announce results of preclinical studies via FDA regulations, please correct me if I'm wrong, but I'm sure they will since they announced the MTA agreement). Therefore, it's impossible to predict when it will be done, and patience is key.
I see, I misread it as Anavex AND a pharmaceutical company, but now I see that it says rare disease company AND a pharma company. Worded strangely though: "between a rare disease and a pharmaceutical company"
I agree that they are referring to the Rett Syndrome Foundation partnership, but the abstract says "pharmaceutical company" which is really throwing me off, since it isn't a pharma company. Either a stupid oversight by anavex or there is something we don't know.
Sure but depends on when they started it
Or they could get a "white squire" (i.e. John Paulson etc) to get a controlling stake to ward off a black knight. There are theories that this happened in the spring with another stock I'm invested in (SGYP), where it is rumored that Allergan was attempting a hostile takeover, and Paulson simultaneously purchased 20-30 million shares to ward off a potentially low hostile takeover price.
No, these are Macfarlane's disclosures, since he is the speaker. All speakers at conferences must disclose any consultancy fees or speaking engagement they are paid for. So basically, Macfarlane is a paid speaker and/or gets consultancy fees from these companies.
"Shares of Biogen are well off their highs after the company in presentation slides for the Clinical Trials on Alzheimer's Disease meeting disclosed an serious adverse event occurred in a patient taking its treatment for early Alzheimer's disease aducanumab. The patient had a treatment-related seizure and loss of pulse. Biogen also disclosed two patient deaths, with are considered unrelated to treatment, according to Biogen."
http://thefly.com/landingPageNews.php?id=2475177&headline=BIIB-Biogen-off-highs-after-disclosing-serious-adverse-event-in-Alzheimers-trial
It wasn't a leak...Adam Feuerstein is just (unsurprisingly) clueless about the CTAD embargo policy. The abstracts were always going to be available at 1:00PM PST (although they were late to be posted on the website), and the embargo policy states that full data (i.e. posters and presentations) aren't supposed to be disclosed or discussed prior to the scheduled time slot. Further proof that he isn't that smart.
I have a password and account, but no way to find the abstacts
This is misinformation being spread. Anavex never said they would announce a partnership in 6 to 12 months. They specifically have stated in their SEC filings that they would "initiate discussions with potential partners and acquirers in the next 12 months." This does not mean they have one set in stone or announced in that time frame.
"They are the next hope in Alzheimer's." YEP.
Totally agree with this.
Sorry in the pharma world, I think ANOVA tests and t tests ARE simple statistics. Mean, median and mode are more like 5th grade math concepts, but I guarantee you he would say missling would be making those up as well. What a joke
The biological half-life (T1/2) for ANAVEX 2-73 is 8.56 hours and 28.74 hours for its metabolite.
Why would you consider this a game? The conference should place important presentations in specific timeslots, that's how a conference works.
These multi-billion valuations your guys come up with are great, but would only happen AFTER the approval of an AD drug. Pre-approval, we wouldn't get these valuations, not even close. Gotta take into account risk of passing clinical development. I say it's an absolute waste if we don't get a $5 billion valuation for a BO at this point in time (pending good results at CTAD)
There are actually 40 million FULLY-DILUTED shares outstanding according to Anavex investor website, so 1-1.5 billion would be a pps of $25 to $37.50. I doubt he would take that low of a valuation.
We need to do phase 2 to establish Proof of Concept for Parkinson's in humans.
They were investigated not for something that they did wrong. A lot of people filed complaints about the short attack following last year's CTAD event, and then an SEC investigation occurred. Anavex has clearly stated multiple times that it had nothing to do with anything that the company was doing. I would put money on the fact that they were investigating the short attack and potential players involved in that ordeal.
LOL all they did was change the title of the abstract. Again, there was no misleading PR. They also had issued a PR reiterating that they believed in the data after there was a short attack following the previous PR with the data announcement. Again, nothing misleading. They have followed CTAD embargo policies, and they are allowed to change abstract titles if they get more info between when they submit the abstract and when the conference begins. Nice try though.
You have to remember they are presenting at CTAD, and there are CTAD embargo rules. They can PR about what they wlll be discussing at CTAD, as in today, but they have to approve it through CTAD press office and it can only be a summary of the abstract. They cannot discuss further at any other conference or press meeting before CTAD. It's not misleading, it's what they have to do if they want to present at THE most prestigious AD conference in the world.
2016 CTAD site embargo FAQs: http://www.ctad-alzheimer.com/ctad-embargo-policies-and-faqs
More detailed rules from 2015 CTAD site embargo policy: http://www.ctad-alzheimer.com/sites/ctad.prod/files/files/CTAD%202015%20Embargo%20Policies%20-%20Updated.pdf
Whole company.