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Health See other Health Articles Title: Lashmet’s “Next 100% Winner” in Alzheimer’s? Stock Gumshoe "ids" likely companies involved Lashmet (investment advisor) isn’t really focused on that long-term potential for dramatic gains, though, he’s looking at a quick double or more — this is from the ad: “… next month, I’ll be flying to Toronto, Canada to witness firsthand what I expect to be one of the biggest announcements in medical history… “If this company’s new drug is declared a breakthrough drug, it will offer hope to the 5 million Americans plagued by Alzheimer’s disease today. “I’ve uncovered one drug company that should benefit most, if this new form of treatment for Alzheimer’s disease is approved…. “I believe this company is about to announce that regulators have agreed to let this drug’s clinical trials end, way ahead of schedule… at the Alzheimer’s Association International Conference I’ll be attending in Toronto.” And then the clues that make clear that it’s not a big US company (like Biogen), or even a US-listed company: “As lucrative as I expect this opportunity to be for investors who establish a position today… it’s ‘off limits’ to most ordinary investors…. “First, you can’t find this stock on the NYSE or Nasdaq. It only trades overseas. “But more importantly, an investment in this company requires a larger commitment than most other stocks. “You’re required to buy at least 100 shares of the company. At current prices, that’s a $6,000 investment, minimum.” OK, so the stock trades at something in the neighborhood of $60 a share. That’s a clue! We can do division! Take that, copywriters! More clues? “Over the past few months, the CEO of this biotech company has been telling investors that clinical trials could stop, based on March 2016 data that showed real benefits to patients with Alzheimer’s. “The CEO even said the trial could stop early, based on ‘the possibility for early clinical success.’ “The drug is currently in ‘Phase 2’ – about halfway through the testing process.” OK, so this is presumably a reference to the actual drug and company Lashmet is recommending, not the “same approach” drug that’s further along under Biogen’s management. And then he lays it on a little thicker: “From the company’s perspective, this drug works so well that it’s now unethical for them to place anyone in the placebo group…. “… the company asked the FDA for permission to end Phase 2 trials early. And I’m predicting the drug will receive designation from the FDA that will allow this to happen, expediting its development and review processes.” And Lashmet says that on the rare occasions this has happened, the drug also gets “fast track” treatment from the FDA and ends up a win for investors. And one final bit of clues: “… this company’s CEO recently just made another big move… one that signals to me that this drug’s fast-tracked approval could come any minute now… “He just presented on how he’s reorganizing the entire company’s focus. “He shifted the company’s focus away from most of its current business… approved drugs that are already profitable… to focus instead on untapped sectors of medicine like Alzheimer’s. “It’s is a bold move for a mature drug company with a dozen successful drugs already on the market… all for a drug that still hasn’t received official approval from the FDA yet.” And a final sum-up of the core catalyst Lashmet is expecting: “I’m convinced that this company will receive permission from the FDA to end clinical trials of this drug early. “And because of this, I expect its Alzheimer’s drug will be fast-tracked for approval… skipping Phase 3, and heading straight to market.” I’ve perhaps gotten even more skeptical about Alzheimer’s Disease treatments over the past few years, so you may have to insert your own optimism here. The FDA has tried to open things up for Alzheimer’s Disease patients, and get drugs through review more quickly and with less stringent proof of success, by some estimations. But it’s also terrifying and, frankly, almost inconceivable to me that the FDA might skip a huge Phase 3 trial to confirm safety for any Alzheimer’s Disease drug — if only because any drug that claims an improvement in Alzheimer’s treatment could easily be prescribed to tens of millions of people in the first year or two. Maybe they can be loose about efficacy, since measures of dementia and cognition are notoriously squishy and there’s a push to try things that might help even if it’s not proven very well, but it’s hard to believe they’d be loose about safety. So what’s the stock? Well, as I noted I probably can’t be 100% certain on this one… but I’m pretty sure the Thinkolator is correct in saying this is Eisai, the Japanese pharmaceutical company (ticker 4523 in Tokyo, though their is an OTC ADR trading in the US at ESALY). The shares closed in Japan at 5762 yen, which is roughly $56… and the ADR is trading close to that amount, which is to be expected for a large company. You would have to buy 100 shares at a clip to buy directly in Japan, probably, and that would be difficult with most brokerages, but the ADR is easy enough to buy. It’s pretty illiquid compared to other $15 billion companies, with only about 5,000 ADR shares traded on an given day, but small investors ought to be able to buy it if they’re interested. I know Interactive Brokers will let you trade in Japan direct if you like, and that’s what I’d probably do if I were to invest in Eisai, but the ADR is not terrible. Why is this the match? Well, Eisai is actually in partnership with Biogen on two monoclonal antibodies for Alzheimer’s Disease — the first one is Aducanumab, which went by BIIB037 before it was named, and the second is BAN2401, which is indeed in Phase II trials now and expected to have the next stage of interim analysis done this month… so there could be news at any moment, though Eisai is not always as aggressive about releasing updates as most US pharma companies tend to be. And they have reorganized recently to focus on two major therapeutic areas: Alzheimer’s and related neurological diseases, and cancer. And they did have interim data in March, near the time that BIIB had encouraging data about Aducanumab — this is what Eisai’s latest presentation notes about BAN2401: “• Phase II interim analysis at 650-patient-randomization occurred at the end of March 2016, and IMC* recommended study continuation without any modification • Next interim analysis at 700-patient-randomization is expected to occur in June 2016 • Continue to explore with Health Authorities on how to leverage the ongoing Phase II study in future pivotal programs should the Phase II study achieve positive outcomes” The anticipated end date of that study is 2018, though it wouldn’t be unheard of to end the trial earlier if they want to push faster — they have gotten to 700 of the anticipated 800 patients at this point. They also have been including the note, “possibility of early success” in their presentations about past interim results for BAN2401, I don’t know if that’s a technical term or just a reference to the possibility that they might be able to move to Phase 3 before completing the 800 patient regimen. Rusty Brown “Recent research has shown that smoking is a significant risk factor for vascular dementia and Alzheimer’s disease, with smokers twice as likely to develop the disease as non smokers…” www.alzheimers.org.uk/sit...s_info.php?documentID=878 “Controlling for study design, quality, secular trend and tobacco industry affiliation, we found a significant increase in AD risk associated with smoking…” National Center for Biotechnology Information www.ncbi.nlm.nih.gov/pmc/articles/PMC2906761/ Michael Jorrin (aka Doc Gumshoe) Sounds right. Aducanumab, along with other BACE inhibitors, may have dosing issues – huge molecule, hard to get enough concentration to the site. Eisiai has two candidates – BAN2401 and E2609, another BACE inhibitor, both early on the development ladder. These were discussed in detail in a Doc Gumshoe last December. Hard to accept regulatory approval without more study, but who knows Bob Schubring Another candidate is the Spanish company PharmaMar. They underwent a reverse merger 2 yrs ago with a paint-and-varnish company whose shares traded in an ADR on the OTC Pink Sheets. So, PharmaMar is now listed in the US…albeit on the Pink sheets. Last month Michael Robinson at Money Map teased the stock, through an I-bank who were offering round lots in the PharmaMar ADR, bundled with a US tax credit for making the investment in an Orphaned Drug…as potentially a huge deal, because PharmaMar intended to transfer their listing off the Pink Sheets and onto the NASDAQ, after a major announcement on a new breast cancer drug. In the course of Michael Robinson’s pitch, they mentioned another catalyst for the stock, was an Alzheimer’s drug that PharmaMar has in the pipeline. From the sound of things, the deal Money Map was pitching was probably a chance to buy shares from an insider or angel investor who had taken a private placement (which was eligible for the tax credit) that’s convertible into common shares (which are legal to offer in the US, as part of the ADR). So from the smell of things, an insider wanted to cash out, ahead of any Brexit turbulence, part of his PharmaMar private placement. And once the SEC had approved the Equity Crowdfunding regulations, the I-bank had a clean shot at selling this weird hybrid of a private placement that converts to a NASDAQ-traded stock, which might bounce like an IPO, but also comes with a US tax credit. Bottom line: I’m watching PharmaMar but have not nibbled. If I needed the tax credit I’d have gone ahead and paid the big money for an introduction to the players…the tax credit represents money someone needs to spend on taxes, and any profit from the drug business is gravy. For someone who doesn’t have immense amounts of taxes to pay, it’s a bit rich for my blood. Post Comment Private Reply Ignore Thread Top • Page Up • Full Thread • Page Down • Bottom/Latest
#1. To: Tatarewicz (#0)
According to Dr. Joel Wallach, Alzheimers is caused by a deficiency of cholesterol. This may be caused by taking statin drugs at some point in your life. And the effects of statins are irreversible. The setting of a cholesterol limit by the 'medical model' is disabling the nation and creating a burden of care that we soon cannot afford. Eat butter.
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