Ray Blanco’s : “What This CEO Says on Nov.7, 2015 Could Revolutionize Modern American Medicine…”

Solving the latest teaser pitch from Agora Financial's FDA Trader

By Travis Johnson, Stock Gumshoe, October 27, 2015

I know I’ve said this before, and sometimes it’s a lie: I’m going to try to keep this one brief.

Agora Financial’s FDA Trader service has a new pitch out — which normally might not get that much attention, since everyone is suddenly terrified of biotech stocks after a brutal month or two — but the promise is not just that a drug will get approved and make you rich… the promise is that this company will “revolutionize modern medicine.”

So what are they talking about? Well, the short answer is, “a cure for Alzheimer’s Disease.”

Which, depending on how long you’ve been investing in or reading about healthcare stocks, will either make you want to reach for your wallet or hide under your desk. Alzheimer’s Disease is by far the largest and most lucrative market that is underserved by pharmaceuticals — and the constant search for new treatments for this awful, high volume disease that has been a money pit for pharmaceutical companies. The disease is challenging and still very poorly understood, the only treatments available now are disappointing and help just some of the patients with some of their symptoms, and any new drug faces extraordinary challenges and very expensive clinical trials.

But, of course, if anyone does come up with a cure or a preventive for Alzheimer’s Disease that’s safe and approvable, they could make a whole boatload of money. So we see pitches about tiny biotech companies that have a cure for Alzheimer’s every now and then.

That’s what this one is today — the ad is for FDA Trader from Agora, edited by Ray Blanco (who has been the default editor of most of their technology-focused newsletters for many years — this newsletter used to be helmed by Paul Mampilly, but he moved a couple buildings down to work at Stansberry)… so what are we told about this secret little company?

Well, here’s why Gumshoe readers are asking about this one:

“On Saturday, November 7, a CEO you’ve likely never heard of will step up to the podium….

“Standing at that podium, he’ll be in front of the most respected names in his industry.

“When he starts speaking, he could change forever everything we think we know about one of the most frightening diseases in world history.

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“What he has to say could revolutionize modern medicine for reasons I’ll show you here today.

“The market frenzy his comments create could also make you incredibly wealthy.

“That’s because, when the markets open on Monday, November 9, the stock of the company this CEO leads could explode rapidly higher.

“If this CEO’s presentation on November 7 goes as well as I expect, starting Monday, November 9, you could take part in an epic share price explosion.

“I’m talking about the chance at gains of as much as 2,150% or more as this tiny company rockets from under $9.00 to $200 and beyond.”

So, 2,150% gains — nice, right? And he implies that, while it “may take time,” the huge gains will start right away on November 9. Assuming, of course, that he’s right about what this CEO is going to say.

Some more clues? Well, let me give you another wee taste of the hype first:

“If You Buy Just One Stock For the Next Year, This is the One

“This CEO’s company might control what we come to view as the breakthrough of the decade.

“Over 5 million Americans, in fact, suffer as I write from the disease this company aims to treat.

“Actually, ‘treat’ isn’t the right word.

“If this company’s trial results continue to progress as well as early reports indicate, this company’s breakthrough could actually ‘reverse’ the disease.

“What we’re dealing with here… for the first time in modern medical history… is the potential ability to take a disease with no cure and no good treatment…

“… and stop it in its tracks. That’s the big picture.

“This advance, it goes without saying, could be unprecedented. No one has ever seen anything like this before.”

OK, OK — enough drooling! I know, I know, it’s supposed to make us filthy rich, and make us feel good about owning shares of the company that finally eradicates the scourge of Alzheimer’s… so what is it?

Final clues for you — don’t worry, I won’t make you sift through the whole ad (you can see it here if you want the water torture version), but we do need to confirm that this company is the one I think it is. The clues:

“For the first time in history, we may have an AD drug on our hands that stops and reverses the symptoms of the disease.

“Here’s the important point:

“Phase 2A testing of this drug took a small group of patients with mild-to-moderate Alzheimer’s symptoms and put them on the drug for 36 days.

“83% of patients had a positive response, and the cognitive skills / memory testing of those patients increased 4x over the current ‘standard of care’ drug.

“Keep in mind, this preliminary Phase 2A data didn’t have optimized dosing. The treatment also wasn’t administered long-term.

“For a small Phase 2A study, this was a profound and fascinating result:

“83% of those who took the drug saw a benefit.

“And improvement in memory function was a robust 4x increase over the current standard drug.”

So the basic spiel is, this company is releasing more detail from their Phase 2A trial for some kind of Alzheimer’s Disease drug, and Blanco thinks it will show continued success and the stock will rocket forward as they progress into Phase 3 and move toward determining whether the drug is really safe and effective on a large scale, making us all gazillions of dollars. But, of course, you’ll “miss out” if you don’t subscribe to his newsletter ($1,600, please) before the CEO gives his presentation in a couple weeks.

And the stock? Thinkolator sez this is one we’ve seen similarly teased many, many times: Anavex Life Sciences (AVXLD on the OTCQX as of today, though it will begin trading on the Nasdaq tomorrow at AVXL), standard-bearer of the Alzheimer’s hopefuls in the junior biotech space for nearly a decade now.

Yes, Anavex will be reporting some results on November 7 at a conference — though it won’t be the CEO, it will be the principal investigator from Australia reporting the results. This will be an updated version of the results they announced a few months ago, since the first part of the two-part study has now been fully enrolled and they have more data. This is largely a dose-finding study, though they’re also hoping for some positive efficacy results and, of course, a lack of surprise safety concerns.

I am not a biotech investor, and not an expert on the disease or the drug, but my impression is that it’s a measure of how desperate we are for any kind of hope in Alzheimer’s Disease that this trial is generating so much attention — the results in July, as I saw it, were that 10 out of 12 patients showed memory improvement, without any kind of placebo arm. It’s hard enough to run a good clinical trial without a double blind placebo, but doing one in areas of memory and cognition, where you’re counting on the interpretations of patients and other human beings to judge whether there’s improvement, strikes me as not very powerful. That’s not necessarily a criticism of the company, they’re still trying to determine what dosing and regiment has the best chance of working and they will certainly be required to have huge double-blind trials before they get approval on this drug — to say nothing of part B of this current trial, which will not be complete for at least a year… it’s just a reminder that, in Alzheimer’s especially, it’s important not to get your hopes up too quickly.

The drug is Anavex 2-73, which we’ve certainly mentioned a few times — it has been the highest profile “hopeful” drug for Alzheimer’s among the junior biotechs for a long time. And it’s history tells you something about how hard it is to develop drugs for this disease — they initially thought they’d be filing for an IND and starting their Phase 1 trials for Anavex 2-73 back in 2008. Ray Blanco’s former colleague pitched this one back in December of last year, too, and he and several other newsletters have pitched it as the “end of the Grey Plague” or the “next blockbuster” for almost as long as Stock Gumshoe has existed (we started publishing in 2007, FYI).

Anavex does have other drugs in development, too — though they jump around some as hope and potential shifts, and they don’t appear to currently be spending money on any of the other drugs right now, it’s all about Anavex 2-73 and Anavex Plus (which is just Anavex 2-73 plus Aricept, the current “standard of care” drug for Alzheimer’s symptoms).

And, as you might expect, the company does not have the capital to run a multi-year Phase 3 trial (assuming they eventually get that far) with hundreds of patients — but it has become more of a mainstream stock this year as they reported good Phase 1 results, started Phase 2, and applied for uplisting to Nasdaq, with much higher trading volume and a rising price… so they should at least be able to raise money on better terms. They also have an agreement in place with their big institutional investor, Lincoln Park Capital, that could bring in another $50 million if I’m reading the terms right — presumably Lincoln park also gets some kind of sweetener in the form of warrants or pricing or something, I haven’t checked.

The presentation on the trial will be at a conference on clinical trials in Alzheimer’s Disease in Barcelona in early November, Anavex’s press release about it is here. Judging from past Alzheimer’s trials I’ve seen over the years, my guess would be that they’ll require another Phase 2 trial or maybe 2b/3a trial if you want to start parsing that, which would probably not start until next year sometime, and they’d require a long Phase 3 trial of a couple years, at least. And, of course, given the past performance of Alzheimer’s Disease drugs and the continued lack of real detailed understanding about the disease and its causes, I’d assume we should probably continue to give them a low number in the “probability of approval” department.

That’s said, I reiterate, as someone who is not not not an expert on this drug, this disease, or even this company — but the symptom-treating drugs that have been developed, have, in the rare cases where they’ve made it through to approval, taken a loooong time. The reward is high — Aricept, despite the fact that it really isn’t a “cure” for Alzheimer’s and doesn’t reverse the progress of the disease, still had peak sales well into the billions before it went off patent a few years ago — so we should expect the risk to be high, too.

For me, the biggest risk is that we’re talking about a tiny company riding high on sentiment and still probably a year or more from entering the most expensive phase of drug development (it’s up dramatically on the year, though that followed a four-year decline from the days when the IND was first being talked about for Anavex 2-73 — AVXL is up a couple hundred percent this year, and is down about 90% since the 2008 highs). I may be a bit too cynical about this one, since I’ve written about the “promise” of a real disease-modifying drug for Alzheimer’s Disease at least a half dozen times over the last seven years, and it’s always been about Anavex, and they’re still just in a Phase 2 trial with 32 patients. But that said, the stock has clearly performed well this year because of the new attention, the progress into early stage trials and lack of bad news and, probably more than anything else, the public attention and massive size of the end market.

If past Alzheimer’s drug hopes are any indication, there are four scenarios I could guess at: A, it could collapse on the next news release or sometime in the current trial because of bad news; B, it could consume a couple hundred million dollars running a big phase 3 trial and fail to show good results because of poor safety or lacking efficacy, and see the share price drop on bad news and capital raisings over several years; C, it could attract a suitor if they get “phase 3 ready” and get bought out or partnered to cut costs, driving the shares up further; or D, it could, maybe sometime early in the 2020s after another 5 years of clinical trials, eventually get approved and be the cure everyone’s looking for. My guess is “B” … but, as I noted above, I may be too cynical on this one and it has certainly gotten some folks excited so far this year.

So that’s what we’ve got for you today — whaddya think? Willing to bet on Anavex this time around? Let us know with a comment below.

P.S. I should note that our favorite biotech columnist, Dr. KSS, has been unimpressed by Anavex in the past — he last commented on it here, I think.


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Lane Simonian
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Lane Simonian

Alzheimer’s disease is not a prion disease. Ironicailly, amyloid plaques may prevent Alzheimer’s from becoming a prion disease, as they may sequester infectious prion proteins.

http://www.ncbi.nlm.nih.gov/pubmed/17360589

But here is another important clue, ferulic acid–a peroxynitrite scavenger–can be potentially be used to treat a variety of neurodegenerative disease perhaps even including prion diseases.

http://www.rsghb.cn/EN/abstract/abstract23047.shtml

http://www.ncbi.nlm.nih.gov/pubmed/21272180

https://www.deepdyve.com/lp/elsevier/effects-of-ferulic-acid-and-angelica-archangelica-extract-feruguard-in-1JIk0sQm6J (Kanaya)

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Lane Simonian
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Lane Simonian

I am having troubles with the reply function, so sorry that these posts are out of place. Alzheimer’s disease is caused primarily by oxidation and nitration of critical receptors, transport systems, and enzymes in the brain. It does not matter how many plaques or tau tangles a person has in his or her brain, if oxidants are being neutralized one does not have Alzheimer’s disease (this is what the nun study showed). All sorts of factors can cause oxidation in the brain. They include but are not limited to mercury, aluminium fluoride, sodium fluoride, diesel fumes, particulate matter, various pesticides,… Read More »

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alanh
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You should join the Irregs KSS threads. You seem to offer what we need and what you may need is defo on offer. See ya there I hope. Thanks for your comment.

Lane Simonian
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Lane Simonian

Name: Anavex 2-73
Chemical Name: Tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride

The best antioxidants contain a methoxy group and a phenol group. That is what you need to partially reverse Alzheimer’s disease. But an antioxidant that slows down Alzheimer’s disease would still be a coup.

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arch1
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👍7795

Lane Given your group of posts,do you know if dimethylsulfoxide,,,DMSO,,, has been
tried with AD and if so, with what effect? fa

arch1
Member
👍7795

Lane Given your group of posts,do you know if dimethylsulfoxide,,,DMSO,,, has been
tried with AD and if so, with what effect? fa

Lane Simonian
Guest
Lane Simonian

Under different circumstances and at different doses, dimethylsulfoxide can act as either an antioxidant or as a prooxidant. I cannot find any direct studies regarding Alzheimer’s disease but here is one positive and one negative study relating to Alzheimer’s disease.

http://www.ncbi.nlm.nih.gov/pubmed/20463302

http://connection.ebscohost.com/c/articles/79827007/dimethyl-sulfoxide-induces-both-direct-indirect-tau-hyperphosphorylation

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arch1
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Lane Thank you. Interesting posts. Frank

bigbuch41
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bigbuch41

Hello Lane,
I read your alz connected articles about boiling ginseng in a pressure cooker to get a medical strength antioxidant to help treat AD. Did you ever perfect it. If so could you share the recipe?
Thanks

Lane Simonian
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Lane Simonian

I was never able to try it as now none of my relatives have Alzheimer’s disease. I was able to get the full text articles for heat processed ginseng (steamed at very high temperatures) and Korean red ginseng (boiled ginseng). The latter produced similar improvements in cognitive tests but it took a longer period of time to achieve those results (12 weeks for heat processed ginseng, 24 week for 9 gram of Korean red ginseng, and 48 weeks for 4.5 grams of Korean red ginseng). After a certain point, the improvements end and Alzheimer’s seems to stay at a steady… Read More »

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OFP
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OFP

No one seems to be looking at their clinical data reported 7/22/16 with a critical eye. This is the data that supposedly shows 2-73 is “4x better than donepezil”. Let’s review… First, the measure reported was not a cognitive test. Instead, it was the P300, a type of event related potential that is expected to be a biomarker for cognition. The P300 has been shown in multiple studies to be have reduced amplitude and delayed latency in patients with Alzheimers. Some papers claim that a treatment effect from Alzheimers treatments can be followed with this measure and AVXL pointed to… Read More »

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arch1
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OFP V important post. Thank you? fa

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MIke
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MIke

Bottom line is…we will see how effective the drug is on 11/7 and we will see if this has been a pump or the science is real.
Good luck to all longs.
Mike

OFP
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OFP

I think its entirely possible the science is real AND it has been a pump. The science will be elucidated over years not on Nov 7. I don’t think current expectations align with that possibility.

Gui_
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Gui_

A story we see over and over.

alanh
Member
👍4086

Im begining to ask myself if we are doing this all wrong. No question; any cure is fabulous for humanity. But are we following SG (and a zllion others) to support medical science or to make money? Charity is a great way to further research.
Im informed that 70 ish % of drugs ultimately fail so, insofar as making money, thats a 3/1 short on any bio (that KSS doesnt first vouch safe-ish)

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arch1
Member
👍7795

alanh That is an interesting thought,,,esp. on binary events that seem to rise steeply up to make or break time,,,possibly short before news,as they often seem to drop on news,,,good or bad. Often though they are not available for options and the only way to short would be to borrow shares from a broker and you must be a whale to do that,,,,in my understanding. which is likely incomplete. Thanks for the idea,,,bears thinking about
frank

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pices
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pices

Opportunities for stock appreciation like AVXLD are very rare….Maybe once or twice in a lifetime. Having bought this stock originally neat a low point of 20c , I sold far too early at 64c, denying myself of a substantial profit return. It hurts to look back now and see how much was left on the table. Arhhh !! The KSS take on AVXLD 3 months back with words of ‘caution’ and ‘dubious science’ on the current Phase 2-73 was the main reason I bailed out. Regardless of what appears to be an extravagant current Agora pitch, the same could be… Read More »

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mike
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mike

I have one question.
Would the Michael J, Fox Foundation and all of these highly respected scientist and doctors be associated with a scam?
http://www.anavex.com/about-us/scientific_advisors/

arch1
Member
👍7795

All can be scammed,,,such is possible. fa

arch1
Member
👍7795

Some of the people,all of the time
All of the people,some of the time
but not all of the people , All of the time……. But always enough to favour a good scam artist making a fortune.

who noze
Guest

scams midcontinent telephomne, the seurity co ln deerfield ffla. i forget the name both pushed by brokers

ocelot
Guest
ocelot

Huh?

tncbg
Guest

They (various newsletters) pushed this one hard through Friday (Nov. 6th). The stock was already taking a dive by Friday so those who were touting it look rather stupid. I feel sorry for the people who paid $1600 to get this “tip” only to lose their shirt on the trade that was touted. Stock Gumshoe was on top of this one from the first tout. Well done!

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who noze
Guest

the beeg scam mid continent telephone

SoGiAm
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$AVXL – U.S. FDA Grants Orphan Drug Designation to ANAVEX 3-71 for the Treatment of Frontotemporal Dementia http://globenewswire.com/news-release/2016/04/08/827167/0/en/U-S-FDA-Grants-Orphan-Drug-Designation-to-ANAVEX-3-71-for-the-Treatment-of-Frontotemporal-Dementi