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Zig, the volume has been to high. Somebody(s) is getting a good size position. Sit tight.
Summary of the Cecchi patent application...as paid for by Anavex(applicant).
Thanks nidan for posting the link to the Cecchi patent app.
I am intrigued by the testing that the inventor Cecchi discusses. He describes a lot of the dosing and testing that this board questioned and guessed about, several months back.
He also gives measures of 2-73 efficacy, and the data, which are interesting as measures against current SOC, and whether 2-73 is really effective!
I always like data, because it is the science that proves 2-73 efficacy or not. And Cecchi describes more than I have seen before for 2-73.
Here are my notes from the patent for anyone that is interested. I paraphrased a lot and summarized. Many of the comments in parentheses are my comments or questions. I like to not only compare 2-73 to normal AD patients, but also to know how much 2-73 has moved the patient back to normal. So I sometimes calculated this value myself below.
Disclaimer...Use my notes at your own risk!
Definitions
DSC Differential Scanning Calorimeter
EEG ElectroEncephalograph -used to access effects for 2-73
ERP Event Related Potentials - Voltage changes locked to some physical occurence (ex.like hearing a tone).
PAF Peak Alpha Frequency - An EEG measurement. AD patients have reduce PAF which correlates to reduced cognitive performance.
P300 A battery of tests measuring patient response to audible tones.
Efficacy tests had 2-73 administered for 36 days to 12 patients with mild to moderate AD as an add-on therapy to patients that were already on donepezil(the current SOC).
Doses were alternately given to each patient both orally and intravenously. The oral doses were 30mg or 50mg and the IV dose was 3mg or 5mg.
ERPs as measured via an EEG provide a sensitive and accurate measure of the cognitive effects of early AD, and was used to assess the efficacy of 2-73.
Here baseline refers to the patients measurements before dosing.
Auditory P300 testing measures patient EEG response to audible tones. Used a COGNISION (Neuronetrix) headset. (Nothing special I think.)
The ERP waveform for the 12 patients, after 36 days on 2-73, more closely resembled healthy subjects. This is seen in figure 5.
Figure 6 and table 1, show the auditory P300 amplitude data for the baseline AD patient, the 36 day 2-73 patient, and a control (healthy) patient. The 2-73 patient shows a 38% improvement over baseline, and (my calc) is 73% back to normal! (wow!)
Table 2, show the button pressing data for the baseline AD patient, the 36 day 2-73 patient, and a control (healthy) patient. This is some type of button response test.
The data shows the 2-73 patients accuracy was only very slightly better than baseline. (Statistically in the noise?)
The data shows the 2-73 patients false alarms were nearly two times better than normal control. (This seems very suspect to me. How is it better than normal?)
The data shows the 2-73 patients reaction time improved 43% back to normal (my calc).
Figure 7 compares the P300 amplitude performance of a control group, a 2-73 group(12 patients 36 days) and a donepezil group(published data).
After one month the 2-73 group is a little better than the donepezil group, but at 1 month (versus donepezils slightly worse meaurement at 6 months). More importantly, both are improving over the control group.
The claims, the heart of the patent, are just about administering A2-73 at different doses and time intervals.
Fitzy, agreed the purpose of the preferreds was not well defined. So I called investor relations and asked them about that. They said it was for takeover protection. They were quite open and willing to discuss the preferreds. Why dont you call and get more details? I just got the basic info. I think after IR has discussed the reason for the preferreds, the company would be in legal trouble if they actually tried to use them for the more cynical uses that have been suggested.
Thanks jstm for the post of the Roth interview.
Totally agree CM looks and sounds very confident. I have seen this before when a company has done the research and has answers, they speak with authority, but carefully, to not give away their research investment.
One interesting question to the private company guy as to whether the venture capitalists were in tune with the new thinking about AD, and he said they were NOT...when they heard AD they ran away.
That may be a good explanation of why our SP is so low. Kind of a third party verification of what has been suspected on this board.
Well, yes, they have a lot more shares than me (assuming). Each common share holder has voting rights to support or decline voting for the proposal. Many owners would be happy with a buyout, many would not. Each must choose.
Dunno. Was not a shareholder then. Dont know where that request ended up.
The Reason For The Preferred Shares Is...
As there was no clear reason for the preferred shares I contacted the company for clarification as to why they requested shareholders to vote YES on the preferred shares proposal.
It was explained that, if this is an important year, with two possible positive readouts, Retts and PD, the company might become a takeover target. The intent is that the preferred shares could be converted to common shares, with voting rights, in an attempt to prevent a takeover.
They are not intended as a way to raise money.
Imo, good to understand how the company is planning and moving forward!
The preferred shares have never been well defined as to their use and holder rights, correct? So we really still dont know WHO these will protect or HOW.
If anyone, has a link to these details it would clear up a lot of the confusion.
I thought it was only worth that if Dr.Missling quit!!
That was the old line anyhow.
Bio, could be that dosage takes a while for improvement,or as you said no signs of improvement yet. I think you know this stuff better than me. Lol. Also, as has been discussed here before, organizations and professionals want to follow protocol, and not stick their necks out.
Again as xena says, the bar is low! Go avxl!
CORRECT ANSWER IS...
If the 2-73 had no positive affect, like a placebo, all patients would continue to deteriorate.
So for PRELIMINARY BLINDED data the answer is.. IF even 1 patient improves then that is good news!! As xena points out their is no effective treatment.
So the greater the number of patients (and percentage) improving, the better indication that the drug is working.
Remember this conclusion is based on BLINDED results, so after unblinding, one looks at the particulars. After unblinding we would like to see 66% improvement, that is all patients not on the placebo.
All 3 ANAVEX TRIAL LINKS
LZ - Australia
trial ID NCT03790709
This link takes you directly to the trial info.
http://clinicaltrials.gov/ct2/show/NCT03790709
PDD - Spain
IDENTIFIER: 2017-004335-36 PROTOCOL CODE:ANAVEX2-73-PDD-001
Select ENGLISH at upper right. Enter 2017-004335-36 in the pop up.
http://reec.aemps.es/reec/public/web.html
RETT – U.S.
This link takes you directly to the trial info.
http://clinicaltrials.gov/ct2/show/NCT03758924?term=NCT03758924&rank=1
Xena, Investor2014 and others have posted links. I have collected all three here, with simple instructions for anyone wanting to use the URL.
You might want to put this in your DD post for users to track.
LOL I was wondering what it was up to. Tnx for the update. Kinda like powerball.
Xena please add Doc328s thumbnail of the trial process to the DD collection. Agree with Kentucky123 they are good for all to understand. Thanks Doc328 for the concise notes.
Not a fast process, but expected of such a system, as all the i's and t's must be dotted and crossed.
Early approval if new trial responses follows 148wk curve?
Since a2-73 seems to be a significant improvement over SOC and biibs BAN, does anyone with trial experience think the new trial, with larger sample set, will get earlier approval if the larger sample set follows the 148 wk curve? It seems like the response is now fairly well defined for a2-73, the main complaint being sample size and placebo. So if a larger set tracks similarly for even a few months, would this be enough to affect early approval?
If A2-73 is three times better than BAN2401, that is huge.
Thanks Peter. Agreed, if either fudged the numbers, well...
I tried to compare apples to apples, in a quick and dirty comparison.
Data Analysis. Peter Karol or somebody with the data at their fingertips...
I think it would be useful to compare A2-73 to the competition BAN2401.
From the CNBC.com article about biogen-and-eisai-unveil-ban2401, they say BAN2401 has a 30% slowing of AD.
Looking at Anavex slide 16 comparing high to low dose,shows 88% improvement versus LOW dose (not placebo..anyone have data for AD decline for placebo? ). So 88% is conservative as I am assuming A2-73 low dose is minimal versus placebo.
So it appears A2-73 is at least 3X (88/30) better than BAN2401!!
(Peter or anybody care to refine this....)
Tessio was always smarter. Nice GF reference!
Regarding buyout price...
Remember Biogen stock went up after a recent ALZ trial announcement and IIRC their capitalization went up about 10 billion dollars.
Also, an esteemed poster here (not me LOL)also valuated Anavex at 15 Billion dollars for the whole pipeline before the Biogen announcement. Good correlation!
Sokol, agree with your thoughts. I thought the same thing after reading Bios good post. A273 will not reduce a tumor size that can be measured, but we have placebo arm now, that improvement can be measured against statistically (to summarize). Also results will be supported by RWE.
Remember also Anavex never claimed to have a cure, but rather an adjunct drug that would result in improvement, over current methods, the extent of which will hopefully be quantified soon.
SP down 4% today.
I did not see the good news!
<sarcasm off>
Yes McM, I meant to say MacFarlane, not Dr.Hampel. I suspect the community down there may be much more attuned to the 2-73 results to date than the rest of the AD world.
OFP, been thinking about the recruitment too. I gotta think back to a previous poster (few weeks ago) that mentioned 2-73s safety Aus trial, had created enthusiasm within the Aus AD community, as word spread. Could be getting Aus recruits may go quickly. Also Dr.Hampel may be getting the word out down there too!
Agreed. Definitely efficacy would be trumpetted. Details may very well be held back.
Most companies are very protective of their data, and the output of their R&D departments. That data takes a lot of capital investment. Companies do not give this data out for their competitors.
They are trade secrets.
GLTAL
Hats off to Piotr! Seems like he is doing his bit to get the word out.
Investor, from Misslings quote (CC quote below), he expects 80% to respond better, and 20% worse. Yet in the 32 person trial, the reverse was found, 20% were super responders, and the 80% not.
Any thoughts on why the 80%/20% numbers seem to be reversed??
So we can stratify the patients which are coming into the study into those who have the gene variant. And those who have the wild-type variant and the wild-type variant is on average in a genetic biobank provided in the overall population to be in the range of 80%. And that population seems to indicate a response better to ANAVEX2-73, then the remaining 20% with a sigma-1 variant.
Dont forget we need to sell because the website is crude!!
Biogen people on call.
Benny I suspect somebody from biib must have been listening in to hear what this upstart has to say. What do you think they feel?
Hearing the confidence and the the data driven trial plans.
I think they feel...(GULP) OMG we gotta do something, and NOW!!
TICK TOCK TICK TOCK
The God Doctor.
No, I disagree with you, he is not THAT good.
He is very good.
A year from now we may say he is Very Very good. Time will tell.
Yeah. It appears the swamp cannot clean up the swamp. If my company had the leaks and tweets that the deep state and swamp get away with...HEADS WOULD ROLL IMMEDIATELY.
Bad Parks, regarding your comment
"Just depends on how quickly they're able to recruit patients."
I wonder whether recruiting will be faster, if word is around the AD world that this Anavex drug seems to be the best hope around. This might lead to fast recruitment. Just wondering...any thoughts?
Humor seems to be big on the board today Parks, so just thought I would say, as you are Korean, that I have been to Korea several times...lovely!
Wow. Recent study and another great data point.
Mice dont know about a placebo affect either.
Thanks for the post georgejj
Totally agree with your last two posts. I suggested a news conference after the presentation...not interested was the reply, let the science talk. Now would be the perfect time.
Yep on the garden analogy. We all hoped for instant gratification today. We must realize the word is just now STARTING to get out. It seems the presentation was to a convention of Realtors or at a football stadium. But NO it was to people in tune with AD. So word will start to spread now, at dinner with colleagues,etc. Some scientist will mention it to his brother. Some aggressive reporter will look into what somebody told him about a new bio drug.
IMHO...go avxl
A company presents science that can provide the best treatment to date for the scourge of Alzheimer's Disease...
...and stockholders hope the stock finishes in the green!
WTH!
That may have been a a big player taking a big position. We not seen anything like that since. Even after announcing the second trial.
Totally agree Dia. The volume is the key. I posted before the case that no one has heard of Anavex, and that AAIC will put us on the map. Information will START to get out about Anavex. Successful trials will guarantee it.
Wow. I would say that would be a good segue into their presentation. I have seen small company's discoveries co-opted by bigger companies when they are "working together", or even just discussing projects etc. Many things can happen. I dont want to even go there. Lets hope this concern is unfounded...but the time move is still unexplained. We will know soon.
I sometimes have concerns that the six were misdiagnosed as well. Then I remember that all signed up, not just super responders, for the extension. And Dr Macfarlane sounds very positive.
We are all on pins and needles wondering what will be presented next week...
More data from extended trial?
Biomarker data implications?
Additional data mining from current data and the above?
More rwe info?
Could be could be just one more step forward for science or could be HUGE BLOCKBUSTERS!
Either way the science will be out there. The word will start to spread.
Second step climbing the mountain for us or a huge second step.
Tnx. Yes i actually called suggesting a press conf off site after the tech presentations! He said no. Oh well hopefully later as you say. GLTAL