Agreed-they should be. It is an impressive result. Good news for GBM patients.

The market reaction is a different story unfortunately. Mr Market is a fickle dude, though perhaps not as irrational as he seems. Still processing this astounding day.

If anyone has a leak, I suppose it’s Al, though he could also be misinterpreting things. Good thing is we’ll all know very shortly.

This PR stuff is kind of messed up. NWBO says “Additionally, the slides used in the presentation will be posted online concurrently with or promptly following the presentation at Virtualtrials.org/Dcvax. The slides will not be posted on the Company's website.”

https://www.prnewswire.com/news-releases/presentation-about-phase-3-trial-of-dcvax-l-for-glioblastoma-today-at-new-york-academy-of-sciences-to-be-available-online-as-well-301544019.html

Al Muesella’s foundation website, referenced in the PR, changes it to “the results of the trial was just released:”

The results of the double blind, randomized, placebo controlled Phase III clinical trial with DCVax-L for newly diagnosed GBM was just released. We will soon post the slide deck of the results as well as the video of the presentation.

Thanks for posting this link! Will be interesting to see market reaction. Recently it seems like a strong sell on the news reaction across multiple stocks in multiple sectors, regardless of how positive the news is. Will FATE buck the trend?

Insider just bought 20,000 shares:
https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=115934956&type=HTML&symbol=VKTX&companyName=Viking+Therapeutics+Inc.&formType=4&dateFiled=2021-06-10&CK=1607678

Insider buy trend still intact according to MT Newswires (whatever that is):
There has been 12 transactions from 4 insiders that resulted in net acquisition of 310,266 shares.

Thanks for the heads up! Haven’t heard of it before but am vaguely familiar with Bryostatin-1 from research into possible cancer treatments I did 20 years ago. Didn’t pursue more in depth research on Bryostatin at the time because it wasn’t available outside of research labs for possible use (was going rogue in looking for things one could actually use at the time). Looks like the target it engages, Protein Kinase C, is involved in Alzheimer’s in some way.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4446718/

My feeling is the ultimate solution to the disease, in its various stages, will likely involve multiple treatments. Hence one reason I haven’t focused on just what I might deem “the best” approach to treating the disease.

One the amyloid hypothesis is finally put out of its misery, these other approaches will come to the forefront for BP. I believe cause and effect have been confused here.

Thanks again! Will be looking into this more closely.

Cassava not alone in showing positive impact on cognition.

My prior post included the following: “The fundamentals of our story are in place, which is this is the first drug—to our knowledge—that can restore cognition,” said Cassava’s founder and chief executive Remi Barbier.

However, Annovis seems like it can make a similar claim to showing evidence of improving cognition:

https://finance.yahoo.com/news/3-drug-stocks-rise-fda-140902798.html

Full disclosure: I’m long both SAVA and ANVS, plus AVXL and CRTX.

Cassava getting some love from Fortune.

Cassava Sciences—a drugmaker with no products on the market—is currently 2021’s best biotech performer

https://fortune.com/2021/06/08/cassava-sciences-alzheimers-drug-share-price-biogen/

One of the things that convinced me to start buying January of 2020 was that multiple insiders bought heavily in December of 2019. Looks like they’re still convinced they’re going to be billionaires.

Next card, perhaps the key one, will flip in July with 9 month interim results. Alzheimer’s patients apparently do not get better for 9 months on “placebos.” A positive result at that point would remove much of the doubt due to open label, etc.

Thanks for sharing this — it’s stories like this that is the reason many of us are here. I share your prayer that DCVax may be part of the answer.

Have you considered drinking bourbon by the fifth and starting a career in Country music?

May your luck change for the better (unless you decide to go the Country route).

Could pop tomorrow—Novartis just disclosed a roughly 10% stake after hours via Form SC 13G.

https://secfilings.nasdaq.com/filingFrameset.asp?FilingID=14681898&RcvdDate=2/8/2021&CoName=SURFACE%20ONCOLOGY,%20INC.&FormType=SC%2013G/A&View=html

Blackrock just disclosed they own 13.5 million shares (6.8%) of Athersys in a form SC 13G filing.

Blackrock just disclosed they own almost 2 million shares (greater than 5%) in a Form SC 13G filing.

I believe I can explain it the difference in market cap. SAVA just published data that shows it not only slows cognitive decline but actually improves it (however slightly). Apparently, no drug has done that in the past.

Admittedly it is still very early data but their prior 28 day study also showed nice improvement across a wide range of biomarkers. Pretty good results in just 28 days of treatment.

AVXL has shown promise against Alzheimer’s but from what I remember it was a subgroup of 5 or so patients who received a higher dose. I had to read between the lines closely as I remember. Promising to be sure but not as much evidence of efficacy as SAVA has at this point.

BTW, I own both AVXL and SAVA.

I agree that it is worth many times more. I bought more this morning (around 42) and am trying to get my head around how to play it going forward. Still extremely undervalued at $2 billion+. This is going to take a bit of time for the market to absorb but things go fast these days. Tomorrow may be more insane.

Congratulations to all longs! The last year has been quite a wild ride up and down and up and down and UP!

Happy as well for all Alzheimer’s patients — looks like we might have a cure for early to moderate disease at least.

BTW, Cassava also makes a test that predicts one’s vulnerability to Alzheimer’s. It should sell well — several millions of tests a year.

Thanks for sharing, Dr Bala! Great overview of the issues.

Kind of disappointing, Mr Doe. You know phase 1 doesn’t prove anything, especially that a treatment doesn’t work. If proof of efficacy was required in phase 1, no drugs I’m aware of would ever proceed to phase 2.

So why would you say it was totally ineffective? How could you possibly know, or even opine that?

She was a little sloppy on that $400,000 per dose number but fortunately she’s not playing mumbley-peg.

The list price for each indicated dose of KEYTRUDA when given every 3 weeks is $9,869.94. The list price for each indicated dose of KEYTRUDA when given every 6 weeks is $19,739.88.

The longest one would get it is 24 months, which works out to about $342,000, maximum, full freight.


https://www.keytruda.com/financial-support/

Another gold star, Sojo. And they say technicals don’t matter.

AquaBounty up 40% over offering price of $6.50 on 12/7/20

Very positive development for a small biotech stock. It seems like they’ve hit an inflection point in the long journey to bring a new source of protein to world, one which might help take some pressure off wild fish populations as well.

A market cap of $500 million should look like an incredible bargain a few years from now.

AquaBounty Technologies, Inc. Announces Closing of $65.2 Million Upsized Public Offering of Common Stock, Including Full Exercise of Overallotment Option

https://finance.yahoo.com/news/aquabounty-technologies-inc-announces-closing-210500771.html

goupupup - you beat me to it! Glad to see someone is still following ATHX!

Great that this trial is finally enrolling patients. Hoping for some news soon from the Healios trials on ARDS and stroke relatively soon.

First Patient Enrolled new Phase2 trial of MultiStem by Athersys

The University of Texas Health Science Center at Houston (UTHealth) and Athersys, Inc. (NASDAQ: ATHX) announced today that the first patient has been enrolled in a clinical study evaluating MultiStem® cell therapy for the potential early treatment of traumatic injuries and the subsequent complications that result. The MATRICS-1 (MultiStem Administration for Trauma Related Inflammation and Complications) study is being conducted at Memorial Hermann-Texas Medical Center, one of the busiest Level 1 trauma centers in the United States.


The objective of the clinical study is to evaluate the safety and efficacy of MultiStem in the treatment of injured patients with severe hemorrhage for the prevention and mitigation of complications that can result following severe traumatic injury. The single-center trial will enroll up to 156 subjects. Subjects will be randomized and administered either placebo or MultiStem cellular therapy following admission to the intensive care unit and after initial resuscitation has concluded and stabilizing procedures have been performed to stop bleeding. All study subjects will also receive all standard of care treatments for their injuries.

"The use of this treatment strategy leverages a long legacy of investigation into the common mechanism of action of down-regulation of the inflammatory response to injury and how it mitigates complications of trauma," commented Dr. Charles S. Cox Jr., Principal Investigator at UTHealth.

Although the causes of traumatic injury are diverse, evidence suggests the hyperinflammatory response following these injuries is similar to other causes of acute tissue injury, such as acute ischemic stroke, acute respiratory distress syndrome (ARDS), traumatic brain injury and spinal cord injury. Activation and mobilization of the peripheral immune system after an injury contributes to local secondary tissue damage. This immune activation may also result in systemic inflammatory response syndrome (SIRS), which can leave the patient susceptible to a range of complications, including secondary infections and organ failure conditions, that prevent or complicate recovery.

Results of pre-clinical injury models and clinical data from human trials in other indications suggest early administration of MultiStem cells may reduce the inflammatory cascade that ensues after severe acute injury by reducing the number of inflammatory systemic immune cells in and around sites of injury, and by decreasing immune cell activation and the release of inflammatory cytokines in response to circulating products of tissue injury. The study will evaluate whether MultiStem’s modulation of these immune responses to traumatic injury can mitigate secondary tissue injury, organ failure states, and other complications that impede patient recovery following severe traumatic injury.

"Prior research conducted in collaboration with UTHealth suggests that administration of MultiStem following traumatic injury has the potential to downregulate the resultant hyperinflammatory cascade, and upregulate key repair mechanisms, improving overall recovery,” commented Dr. Robert W. Mays, Vice President of Regenerative Medicine and Head of Neuroscience Programs at Athersy.

Complete article here:

https://finance.yahoo.com/news/uthealth-houston-athersys-announce-commencement-110000736.html

I’ll reveal my status as an ignoramus on this by asking: is the DC-Vax-L phase 3 trial partly funded by the NIH?

Most likely. It is also possible the orange juice flows from higher up the chain than that. After we get some resolution on this multi-year, slo-motion drama, I hope to share some admittedly speculative thoughts on that.

I get where you’re coming from. We can hope it’s from confidence, not contempt.

Yes, long term potential here is immense and was further validated today.

Agree that it will take time for the market to understand what is going on. I think a couple of things held back a bigger move today. First, the primary endpoint was safety — not very sexy. Second, the disease is unknown to most people. Third, the press release wasn’t straightforward. Perhaps it was because I had essentially just awakened but I found myself having to focus a couple of times to get the significance of a couple of sentences. Finally, the summary at the end left out the efficacy endpoints!

I’m hoping it starts a steady rise from here as the implications of these results spread through the investment community. In any case, I’m happy holding my fairly large position (2 1/2 times my normal maximum).

tootall, if you don’t mind, what company had the radical approach to cancer? I’m heavily involved in researching cancer treatments in general but there is so much innovation going on these days that it’s easy to miss important early work. A significant part of my research is in prep for potentially helping two family members know their options if they happen to have a recurrence.
TIA

10Baggerz, Seems the Riddler answered his riddle (“What satisfies and benefits everyone? Figure that and you will have your answer.”)

Indirectly he also implied that getting the messaging right is key, from the perspective of providing the enemies of the company with the smallest possible target after TLD is announced:

AF’s idiotic post about mineral oil placebo after Amarin shared results sunk the stock on the following Monday. I imagine AF, Stuppy, Wick (remember their journal article comments) and others won’t be lobbing syringes of orange juice after TLD but balloons full of urine.

From my zen koan post:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160134952

Keep an eye on Stuppy—he was a dodge ball champ in college.

Greater than 100% short outstanding. Who knew that all it takes for a Christmas miracle is a little human greed.

This is why many of us are here. Thanks for posting it!

I’m sure your guess is at least as good as mine but I would think expertise would have helped NWBO meet its rough timeline on analysis and messaging after DL instead of extending it.

A mult-year standstill works against NWBO stakeholders’ benefit ultimately. Whatever expertise was on offer should have accelerated the process, not extend it. On the other hand, a long delay in bringing a new product to market benefits others already selling into it, so if LP was playing footsie with a BP suitor all those years, she may have had her affections trifled with.

As far as suppressing the price for years as a purposeful strategy, it seems insane to me for many reasons but then again, I stopped at 3D chess and even then only played once.

None of this is to say I have any better answers. Looking forward to the eventual revelation of results and the unveiling of many mysteries. However it turns it, it will be fascinating.

So how far back do you believe these purposely self-inflicted wounds for the benefit of an external entity go? There seem to be a long string of them which makes it hard to discern a beginning re: your hypothesis.

Great points!

Thanks for the clarification.

There does seem to be a pattern. Seems like we’re due for another clue soon.

I thought the idea was to help all shareholders.

Perhaps we can agree that the riddle was meant to obfuscate rather than enlighten. Or maybe we can’t agree on intent but agree on effect.

That doesn’t fit well with the Riddler’s latest challenge since keeping the stock price low only helps a potential acquirer.

If Linda is so savvy in business, why would she do that (in light of the Riddler’s challenge)?

When something’s not right it’s wrong.

First thing to notice is that shareholders interests are the focus of 10B’s question, not patients, LL’s place in the pantheon of medical researchers or the FDA, etc. (BTW, thanks for sharing this 10Baggerz!)

Maybe he was having a bad day but the professional response is “Great question.... “ or, if it was an absurd/stupid question (whose existence is doubted by many, since we are all at different stages of understanding), he could have answered, “Thanks for the question...” He could have sincerely meant that since answering shareholder questions justifies his paycheck.



Zen koans — an outside-the-box approach to public relations! Even “honest” Abe’s press secretary could have benefited from this innovation.

Here’s an opinion worth two cents: Our current location on the timeline of this multi-year drama is post-unblinding, pre-TLD. At least one wrinkle is most likely to have surfaced in all this data and analysis and messaging.

It is to the benefit of shareholders of all classes to “get this right.” We only get one shot at doing the analysis right and messaging the TLD in the best possible manner.

Both aspects are critical. The FDA holds the knife to our throats and the response of NWBO’s enemies to TLD should always be taken into consideration.

All the other speculation seems like cart/horse confusion. Getting it right seems like the answer that requires the fewest assumptions and takes the current context into account.

Where’d I put that razor? It was here a minute ago.

AstraZeneca agreed to buy AlexionPharmaceuticals for $39 billion in cash and shares, adding a specialist in the treatment of rare diseases and immunology to its portfolio of medications for cancer and other illnesses.

The offer values Alexion at $175 a share, a 45% premium to the closing price on Friday.

In the sale to AstraZeneca, Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares for each Alexion share.

Alexion had $5.9 billion in sales for the 12 months ending with the third quarter of 2020, with a 24% growth rate, AstraZeneca said.

Alexion has specialized in developing drugs that selectively inhibit immune factors to fight diseases that involve the body’s protective system. Soliris, the company’s biggest product, is a monoclonal antibody approved in several countries for treatment of immune-related conditions such as paroxysmal nocturnal hemoglobinuria.

Soliris had about $4 billion in 2019 revenue. More recently, Alexion launched Ultomiris, another monoclonal antibody. The company announced plans in April to conduct late-stage tests of that drug in severely ill patients with Covid.

High-priced medicines for exotic diseases can generate billions in sales from a relatively small group of patients. Snapping up drugmakers that focus on them has been a popular way for larger pharmaceutical companies to purchase sales growth in recent years.


More info in full article:


https://www.bloomberg.com/news/articles/2020-12-12/astrazeneca-to-buy-alexion-for-39-billion-in-cash-and-shares

Everything is aligned to shoot NWBO into orbit!

https://www.msn.com/en-us/news/technology/jupiter-and-saturn-will-form-a-rare-double-planet-in-the-sky-before-christmas/ar-BB1blXxK