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Agree that looking at subgroups is not a good sign, AFTER you unblind data.
I’ve never designed a clinical trial, but it seems taking into account known, significant factors BEFORE unblinding might be a smart thing to do. Otherwise there might be a lot of recriminations if that factor, unaccounted for, bites you in the ass. In a manner of speaking. A postdoc I once worked with said that. We were in the lab, not a bar.
Great — I hope successful roll out doesn’t depend on electricity, hospitals or central government.
(Sorry, just finished watching 12 Monkeys)
Great use of a Python reference — Thanks for the laugh!
Mr FUD’s analysis is flat out wrong. He’s just assuming that DCVax-L doesn’t work, which may be reasonable for someone named FUD, but not for anyone else.
Know-fear, I 100% understand why my post might sound crazy.
My response to LF was mainly geared towards him. I assume, based on his recent posts, that he has gone further down the coronavirus rabbit hole than I have. Given that, I shared some initial impressions. I was not trying to prove a case. My approach was casual on purpose. Without hard evidence presented, I expect the majority of the few people who read it without being deeply familiar with at least some of the topics mentioned would pretty much reject it all out of hand.
It is too early to come to firm conclusions on many things corona-related, including less controversial things like fatally rates, proper responses, etc. We are in the “fog of war” state of a series of events filled with contradictory reports and a healthy dose of misinformation. Separating the wheat from the chaff is a daunting task.
It is nearly impossible to do without some awareness of the relevant history and context. Going on the assumption that you are a fact-based, rational person, I recommend you watch the excellent Netflix documentary series “Wormwood” that I mentioned. It is based on intelligence reports, mainstream news stories, court cases, Congressional hearings, a forensic autopsy by a world famous pathologist, and an amazing amount of archival film footage. It is directly relevant to the events of today.
Perhaps your reaction is, “Geez, I’ve got better things to do than spend several hours watching a Docu-series on events from years ago. He really is crazy!”
Well, the series is “entertaining” in a broad sense, so if you watch TV, it isn’t a bad way to spend some time.
And, considering that coronavirus is likely to impact our future for years to come in ways we can only speculate on now, it might be worthwhile to start to understand its broader context. I can guarantee that you will not get that without making some effort.
Of course, there are only so many hours in the day, and many competing priorities, so skipping my suggestion is entirely reasonable.
In any case, I hope something I posted here before is not relevant for you:
“A key indicator that one is not committed to the truth: contempt prior to investigation.”
Best of health to you and your loved ones!
Since I was assuming LF was familiar with a lot of details, I wasn’t attempting to prove anything.
Here are links to a few things mentioned:
The National Microbiology Laboratory (NML) in Winnipeg shipped potential biowarfare agents to the Wuhan lab.
https://nationalpost.com/news/canadian-lab-immersed-in-rcmp-probe-sent-ebola-and-another-deadly-virus-to-china-health-agency
Zaosong Zheng, arrested for smuggling vials of biomaterial from Boston to China and Harvard Professor Charles Lieber, arrested for lying about his work at the Wuhan University of Technology.
https://www.justice.gov/opa/pr/harvard-university-professor-and-two-chinese-nationals-charged-three-separate-china-related
Chinese biologist arrested at Detroit airport with vials of MERS and SARS viruses
https://news.yahoo.com/suspected-sars-virus-and-flu-found-in-luggage-fbi-report-describes-chinas-biosecurity-risk-144526820.html
US intelligence reported, in November, 2019, to the Pentagon and the White House, that an outbreak in China was occurring that could be a cataclysmic event. This was according to two military officials familiar with the report. After the story broke, the military denied such a report existed.
https://abcnews.go.com/Politics/intelligence-report-warned-coronavirus-crisis-early-november-sources/story?id=70031273
The virus may not have originated in the wet market:
https://www.businessinsider.com/wuhan-coronavirus-may-not-have-originated-from-wet-market-2020-1
Why I jumped early:
https://www.amazon.com/Coming-Plague-Emerging-Diseases-Balance/dp/0140250913
Quite a sack of hot potatoes you got there buddy — thanks for flinging it this way!
Re: Moderna — wasn’t much there in terms of detail but I get a sense of the unethical issue. Unfortunately, the presentation assumes familiarity with a lot of their past videos.
This seems like Cottrell’s first big rodeo, given his seemingly sincere, but bewildered question as to why the media doesn’t ask Fauci about his many connections to pharmaceutical companies. Just an observation, not a criticism. It’s a deep, dark world and he just fell out of bed.
Regarding the larger topic of the video, I read the biorxiv article in question when it came out, suggesting that 3 small, segments of HIV gp120 gene were *inserted* into separate positions in the coronavirus spike protein gene. The 27 base pairs involved matched exactly between corona and HIV in these 3 “uncanny, surprising” inserted segments. When the corona spike gene is expressed and the protein folds, the 3 HIV-related amino acid sections come together magically in physical space in the coranavirus spike protein and supposedly enhance coronavirus’ ability to infect cells.
It seemed like it could be the barrel of a smoking gun for a bioengineered virus. At that point, I wasn’t in a position to do additional validation on it other than to read the article and see that the base pairs matched. Of course, the article was later “withdrawn.” Perhaps it was flawed. Perhaps it was a career-limiting move. Perhaps something else.
There seems to be a crazy amount of viral gene-related shenanigans at Harvard, U of NC, Ft. Dettrick, the Canadian and Wuhan labs, etc... Of course this kind of stuff goes back pretty far, even if you ignore things like catapulting diseased bodies over castle walls. If you like Errol Morris’ work, and have access to Netflix, his relatively recent, multi-part documentary Wormwood is most excellent. It covers the suspicious death of biowarfare researcher Frank Olsen who worked at Ft Dettrick in 1953. His death is also tangled up in the early LSD research under MKULTRA. The early 50’s weren’t as straight-laced as they are typically portrayed. Some of this came out in Congressional hearings in the 70’s, though the hearings were ultimately a limited hangout. His son Eric’s lifelong obsession with solving the riddle of his father’s stated manner of death, “he jumped or fell through a hotel window,” is very compelling. He does an enormous amount of genuine detective work over decades and ultimately uncovers a lot of truth.
Back to the Webb/Cottrell video: The Lisa Page/Peter Strzok connection seems incredible at first glance, as in, I find it hard to believe they’re popping up here after the whole Russiagate fiasco. But who knows? These types keep showing up in the strangest places, don’t they? That old tramp E Howard Hunt comes to mind, as one example. Were he still alive, he might have been pressed into the role of Lee Harvey Fishmarket.
Prior to any speculation about the origins of coronavirus, I had assumed something significant was up when the Chinese went bat shit crazy (though I believe it’s been shown the virus didn’t originate at the Wuhan wet market and that the viral video of the cute young woman eating bat soup was shot in another country). Locking down eleven or so cities in response to the original outbreak and quarantining all the healthy people living in them got my attention.
What in the world were the Chinese seeing? Certainly not a run of the mill pig flu. An HIV-positive gay bat flu? Perhaps a trans pig-to-gay-bat flu? That sounded engineered but early info was especially sketchy.
Whatever was going on, I wasn’t going to let some crazed trans bat bite me on the neck without putting up a fight, even if it were possessed by the spirit of Catherine Deneuve. I immediately jumped on PubMed and researched ways to boost my immune system, especially against viruses. Vitamin D, yes, as well as several other witches’ potions and old wives’ tales, cleared the bar. Who knew that PubMed hadn’t gotten around to scrubbing Elderberry from their database?
Let it be known that I recommend against ingesting or injecting bleach.
All standard disclaimers apply.
Regarding BARDA.
As you know, Athersys was contacted by BARDA and received their “highly relevant” designation, yet they do not show up on BARDA’s site as a current partner. I contacted Athersys about this and was told it’s a multi-step process, that is still on-going and that they hope to provide an update “soon.”
Soon and government processes...you may want to take that combination of terms into consideration.
Stems cells used successfully on Chinese covid-19 patients, admittedly anecdotal at this point but promising that covid-induced ARDS also responds to stem cells.
Hey ya’ll. Speculating that Friday’s move in Athersys was a sympathy move with Pluristem, which was up roughly 20% on non-dilutive funding of 50 million Euros for a covid-related stem cell treatment:
https://finance.yahoo.com/news/pluristem-secures-50-million-non-100010858.html
Pluristem is an interesting company as well. They are Israeli-based and have received a lot of support from their government through the years.
Very long ATHX — I believe it’s move today was in sympathy with Pluristem.
https://finance.yahoo.com/news/pluristem-secures-50-million-non-100010858.html
Wish I had more FATE — was caught napping on its move down to 20 but things are volatile these days so most likely another opportunity will present itself. Their recent deal with JNJ is very promising and their platform is so flexible and open that they could do more of these kinds of deals and still have a lot of targets left for themselves.
How Moderna is an unethical investment? I’ve no doubt there are innumerable ways but I haven’t followed it closely enough to come to that conclusion. Curious minds want to know...
Not that it really matters, but prp1 should have been Pgp1 (P-glycoprotein) in my reply to Longfellow.
I’ll take this opportunity to share an article on drug resistance in Glioblastoma since it is relevant to berubicin.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4518733/
Agree LF, “unique” wasn’t the best choice to describe berubicin, since TMZ/tomozolomide made the blood-brain barrier crossing claim roughly 2 decades ago.
Berubicin is apparently the only anthracyline that has the same BBB-crossing ability, so it is “unique” among the anthracyclines, as they like to insist as long as TMZ isn’t within earshot.
I assume this non-unique uniqueness is kind of a big deal for the following 3 reasons: 1) oncologists like their anthracyclines, so it may allow them to use an anthracycline against GBM. Not big on our agenda but onc’s call the plays.
More importantly 2) Berubicin works by a different mechanism than TMZ, which should allow it to target the non-methylated tumors that are resistant to TMZ, as a first line therapy, and as a second line therapy after TMZ failure against methylated tumors.
And last but not least, 3) the design feature that enables berubicin to cross the BBB also makes it “impervious” to two of the key multidrug resistance mechanisms that typically foil chemotherapy (Prp1 and Mdr1, two protein pumps that get rid of toxins from cells). This is actually kind of neat and atypical for a chemotherapy drug, though of course it doesn’t guarantee success against cancer. Cancer, like our intelligence agencies, has six ways from Sunday at getting back at you, in the immortal words of Chuck Schumer.
The phase 1 trial results were promising for such an early trial. They got one complete response that lasted 13 years and extended progression free survival by some measure, for what that’s worth. Not bad for a phase 1. Also, no signs of cardiotoxicity, which is a key issue with the anthracyclines generally. Myelosuppression was the big adverse effect, which was “manageable.” Buyer beware on that description.
So I’d say a better profile that my initial impression but as you said, there is still a mountain to climb, especially in GBM.
Here is an oldish article describing some of this in more detail. It seems they’ve had issues pushing this drug forward in a timely manner. Perhaps few are interested in chemotherapy drugs these days.
http://ddn-news.com/news?newsarticle=12361
Blue skies — check out my reply to Longfellow for more on berubicin, to follow shortly.
I don’t want to rain on any parades and certainly wish the company has found a treatment that significantly moves things forward for GBM patients.
(Here comes the inevitable However) Berubicin is (just) a new form of anthracycline, a work horse category of chemotherapy. The unique thing about berubicin is the capacity to cross the blood-brain barrier, so it can target GBM. But being a chemotherapy, I don’t see any reason to think it’s effectiveness won’t be in the ballpark of temozolomide, which, while certainly useful, isn’t going to move the ball significantly forward from where we are currently.
Anthracyclines are subject to multi-drug resistance, so it will ultimately fail for most patients. In the mean time, they are at risk of serious side effects like cardiotoxicity and myelosuppression, as well as secondary cancers like leukemia, for those fortunate to survive.
These kind of chemotherapy trials remind me of the old saying about Woody Hayes’ approach to offense at Ohio State—run the fullback up the middle every play, resulting in 3 yards gained and a cloud of dust.
Unfortunately one needs 10 yards for a first down.
This analysis is separate from whether the product will be economically valuable to the company. It probably will be, if I had to guess.
Other therapies are keeping GBM patients alive for years? I admit I’ve got a lot of plates spinning in the air and can’t keep up on everything. What are they? I might like to invest. I’m not unconditionally wedded to NWBO.
AF to join his buddy the Pharma Bro soon?
Well, probably not, but a flame of hope can get one through a long, cold night.
Based on 30 years past estimate experience, I guess August 24th. If I’m close, I’ll explain my reasoning. Most likely, I won’t have to.
BTW, this is a great idea—the whole “wisdom of the crowd” thingy. Worth trying in our little world of interest.
Considering all the trials and tribulations we’ve had to put up with over the years, I had expected another beating to see if it improved my morale. Given all the caveats and hemming and hawing in their past communications around timelines, this announcement was a model of clarity.
LP: “Finish line is in sight”
(Me squinting): “You mean that yellow tape fluttering in the breeze?”
LP: “Yes, that’s it.”
Me: “It looks like crime scene tape to me. You’re sure it’s the finish line?”
LP (exasperated): “Oh my god, what is wrong with you people!”
Going in as guest works, since apparently I can’t be bothered to save my proxy info.
I’m glad the music changes — the song that was playing when I logged in gave me a strong hankerin’ to chew tobacco.
This brings back a memory I have suppressed — I bought SBUX on its IPO day in the early 90s in the low 20’s (was priced at $17). Sold around $27 a few months later and made around $300, maybe a 13% gain. Was afraid of losing what profit I had because of negative price action.
If I still held it would be worth $443,000 today — without taking into account dividends. Apparently SBUX is a dividend machine, so that’s probably another $100k as well.
Jesse Livermore (the original trader from the 20s, not the AMRN guru) said the key to making big profits was the patience to let your profits run.
He made 3 fortunes worth over a million bucks back when that meant something. Unfortunately he also died broke.
The History Channel will now resume its regular programming...
Wow - nice run up into the close. And the market cap is only a bit over $150 million.
Congratulations to all who have held on. Long way to go!!
$300 mil MC is the minimum, so $600 is doable — especially when the sky is the limit
Analyst in earnings call let slip the following:
Tom Bishop
But is there some reason for the acceleration? (Increasing the number pad trial sites in the AD trial) I must admit to having had some exciting anecdotal news of patient improvements coming out of Australia.
This may be one of the reasons the stock price has started to move recently. The old $300 million market cap “rule” (if there is such a thing) before results are announced may be coming into play.
Xena, I think the PR was a bit of a train wreck from a public relations perspective — way too technical early on, buried the lede. I suspect that most analysts who don’t follow the stock didn’t grasp the significance of the results. On the surface, it’s a small sample size in a phase 2 study in a disease with scores of failed drugs. The company is a microcap at that so the assumption is “Nothing to see here!”
The CEO’s first comment is “The results show the trial should proceed!” I think the guy at TDA cut and pasted and left to grab his morning bagel.
BTW, I’m not suggesting Missling should have hyped the results. The PR could have certainly been clearer however.
The price action was kind of weird today — just a steady march up, roughly 30%; no pop in price. It even went slightly negative in the first half hour! This shows that the market hasn’t really grasped the results, and it took time for those who ultimately did to get to that point and buy.
BTW, I tripled my position today — to the full size I’m willing to lose on any investment (such as Nike or PEP). Given the speculative nature of AVXL, my new position is pretty oversized from my typical risk perspective.
They are finally having the Advisory Committee meeting for the expanded label — fingers crossed the indications are broad!!
https://www.barrons.com/articles/amarin-stock-fda-fish-vascepta-cardiovascular-heart-attack-strokes-51573737447?siteid=yhoof2&yptr=yahoo
Woodford fund closing, Big haircut expected
Did a quick check and didn’t see that this has been posted.
Zirabev is a biosimilar (for bevacizumab), so the only way it could be considered to have moved the ball forward in cancer treatments is through wider availability. Since bev looks like a dead end in rGBM anyway, it won’t really have an impact from a patient’s perspective.
Here’s a recent article on biosimilars suggesting a fairly bleak future for them in terms of the companies involved in their development as well as for impact on patients in the US:
Small world!
I’ll see if I can track down the Mayo brother’s quote supporting Coley/Coley’s Toxins. It’s in one of several references I’ve read recently but the exact one is escaping me at the moment.
[YIIF]
More acronyms. I guess the sun never sets for some Brits...
Btw, I must point out that I knew what NHS was.
Mark is head of the CCGTY. I remember you mentioning him favorably in the past. What is the CCGTT exactly?How would Mark / CCGTT fit into our parochial NWBO picture?
Good one!
Sorry — I ask you to translate British acronyms, but use my own without explanation. Typical American!!
FMI=Forgive My Ignorance
Longfellow, I’m sure I don’t rank around here enough to be among the Three Clueless Ones, but I do feel that I have learned from your posts and make sure I read each one.
The clueless leading the clueless. Carry on.
Greg is wise beyond his years.