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Thanks for the article. After looking at the Biogen Aducanumab results recently, I tend to agree. BTW, one of the staunchest believers in the amyloid hypothesis is Dr. Paul Aisen, who is on the Anavex Scientific Advisory Board. So one can argue that the Anavex SAB is not made up people with "narrow views", pushing the cellular homeostasis agenda. A good sign.
IMHO
No. And neither does Amgen, Novartis, Banner, Biogen and others.
“If we determine that our BACE1 inhibitor can prevent or delay the onset of symptoms in healthy yet high-risk populations, this would represent a tremendous breakthrough for those that may face this debilitating disease.”
frol, you mentioned in a previous post that it looked like the super-responders were mildly impaired. Don't you see that as potentially suspect? Why only them? When screening and assessing such patients, the diagnostic accuracy of the MMSE for detecting these individuals with baseline MCI is questionable.
From Wikipidia: Since 2005, the FDA and European regulators have required that nearly all new molecular entities be evaluated in a Thorough QT (TQT) study to determine a drug's effect on the QT interval.
They were so starved for content that not only repeated old information but also spent time on irrelevant points like QTc
I agree and I am glad to see I am not the only one with exact same interpretation.
'Tip of the Iceberg' makes a nice visual metaphor that one could apply to other aspects of Anavex Life Sciences. But taken strictly in the context of how Dr Missling used it he was only speaking of the data revealed so far in the ALZ P2 trial up to that point, the obvious easy to see things as only the 'Tip' and that by far greater portion of the information from the trial would be revealed by the PK/PD data as the hidden part of an iceberg is by far the greatest mass and supports the tip.
One could also use the metaphor to describe how testing of A2-73 in what they have already tested for is just the Tip of the Iceberg in that A2-73 might be useful across a whole range of CNS and other disorders but that is not how Dr Missling used it, it was in context of the information from the ALZ P2.
At an Alzheimer's conference heh...
Hottest freebie at a trade show was a memory stick.
Well, they did mention it in a previous release Oct 12.
Further data will be presented at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in November 2017.
Why no pr about the ctad? Strange. You give out speakers but no pr. Wtf!
Agreed!!! I will turn from the biggest basher, to joining the cheer leading section with hope.
The significance of the trial design and design approval by the FDA, can not be understated.
I hope this title means we will see the trial design and the rationale for the endpoints, exclusion, inclusion and other parameters.
The trial design will be driven by the 57 week data as well as the 104 week data they have so far. Hope this also means we get to peek at the 104 week data too.
What we need is unequivocal efficacy data. Does it work?
re: what else can AVXL present at CTAD,
Inclusion/exclusion criteria based upon KEM analysis extended by DNA/RNA profiling along with gut biome data.
As a PR bonus following CTAD perhaps Part C longitudinal data and update on how the patients are doing now. As extra bonus more concrete information on trial start.
What have I missed or what else could it be?
How about knowing the reasons for low blood concentrations or why the ones with high blood concentrations didn't respond well? And perhaps how they will be addressed? Knowing how to select patients for certain success will be a huge value to the company and investors.
A lot of people assume this means LPC type companies want to decrease the share price of their clients (toxic financing). I don’t believe that’s the case. Remember they want to sell those shares the next day for more than they paid so they don’t want the share price to decline. They would love to see it increase on that day.
Please provide a link showing this is Anavex's 2nd attempt at bringing 2-73 to market. I have never heard this before, and to my knowledge, isn't true.
NOW explain why NINE YEARS and no double blind study=the only path to market
After all, avxl has cured the super responders and restores homeostasis.
A deal like this does two things: 1) makes you wonder about just how much $$$ avxl can get and 2) makes you wonder why the heck the deal hasn't happened.
Is it possible that Biogen's in-vitro testing was positive but the in-vivo testing was not so great and thus AVXL eliminated MS from their pipeline. Before I'm attacked....I am long. I just like to explore other possibilities.
A member of the AVXL FB Group was messaged by Anavex Investor Relations that the MTA with Biogen is still active.
Is it possible that Biogen's in-vitro testing was positive but the in-vivo testing was not so great and thus AVXL eliminated MS from their pipeline. Before I'm attacked....I am long. I just like to explore other possibilities.
It is very sloppy to have 57 weeks as first bullet point and then not clarify the last applies to 5 weeks. Oh well...
Congrats to those who called today as the patent-PR-day!
re: option strategies
Yea, I agree that what I outlined is not an "air tight" explanation primarily because we lack a lot of the details, as you pointed out.
I also agree that there is a slight bullish nature of the position.
Options and option strategies are complex as it is, without details they are that much harder to evaluate.
IMHO
Can someone with option experience explain CITADEL's reasoning as to why they hold the following? They are first time filers for their long position.
13F-HR CITADEL ADVISORS LLC Long 16,293
13F-HR CITADEL ADVISORS LLC Put 12,900
13F-HR CITADEL ADVISORS LLC Call 29,700
I stayed at a Holiday Inn Express, so I think I can handle this, LOL.
Missing from the above are strike prices and expiration times, so I will make a number of assumptions. I am assuming the 12,900 put means 129 contracts and 29700 call, means 297 contracts. Note: 1 contract = 100 shares (as everyone should know).
This may be one scenario.
1) The fact that calls and puts implies a straddle strategy. Google it.
2) If they are long the straddle, they paid a premium. Assume they did.
3) They are expecting either a big move up (lose on the put & profit from the call)
4) or expecting a big move down (lose on the call & profit from the put)
Now, given they are long 16,293 shares, I am guessing a covered call in the form of 162 or 163 contracts where sold to collect a premium, which offsets the premium in step 2) above. Thus a relatively free straddle.
So I am guessing, 12,900 put shares and 12,900 call shares, forms the straddle and the remaining call shares (29,700-12,900 = 16800) is used as the covered call strategy (technically, this is short the calls, which is not what is indicated, but that is my assumption).
IMHO
However, do you know of any reason 2-73 would have an advantage or show stronger results relative to the dozens of other compounds that have already shown positive results in this type of testing?
That "data" pertains to "oxidative stress" not AD.
No 15 month data. That's BS...
OK - we know that the February run up was due to Park West Accumulation.
I don't remember seeing an Anavex logo on their site either.
6. Examination of subgroups is always very dicey in a statistical sense and with small groups even dicier...bordering on irrelevant at best. Focus on the super responders may be of interest but it is far less relevant than the full group.
Funny how they went from Sell to Buy in a couple weeks with "no news". Must have had an epiphany :)
Thomson Reuters/Verus upgrades ANAVEX LIFE SCIENCES CORPORATION from HOLD to BUY.
Profit taking or bad news?
Good question
Are they buy and hold types or more like traders?
Re: Park West Asset investment
Thanks for posting. This is very meaningful. More to come.
This is really good news
According to filing of SC13-G, Park West Asset Management is owner of > 5% of the company.
http://archive.fast-edgar.com/20170213/AGAOJ22CI222I2Z2222N22ZZRFVOZ2T2E292
IMHO
I agree, a good post. You, frrol and a few others do a great job of keeping it real. A further comment on the analyst's complete quote:
Conservatively, we assess a 18% probability of success for the Alzheimer’s disease program given the promising Phase 2 data and the need for a safe and efficacious therapeutic for mild-to-moderate Alzheimer’s patients. We conservatively assume that ANAVEX 2-73 will capture ~10% of the estimated market with peak year sales of $6B
But the first 2 tweets state that Missling and 2 other bio CEOs will be on The Deal February 7 to discuss the future of Pharma and where the industry is headed. Good exposure!
The cost of phase2/3 for central nervous system drug cost on average $13,000 per patient.
So I guess we can take this to mean Anavex is funding the Alz trial on its own. Or at least hopes to. 17!million. Proababy not enough. Where's the money coming from then? Missling knows. We have all made a few guesses. All quite possible.
Waiting until commercialization of proven success to get a partner means Missling doesn't want to give away the company or pieces of it if he doesn't have to. This speaks to his confidence in running a successful trial. No help needed. Thanks but we got this one.
If the drug works than it will be patentable. There is nothing patented because there is nothing that works at this time. We are back to square one - does the drug work? If so, who has developed it? If they developed it, do they own it? If they don't own it, then who does? Can they prove it?
IMHO