Kind of agree with this take and have hinted at same with my mentioning of low rates going away and TINA abating.
OT: Stock and Investment Thread
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She has been pretty insightful on macro issues over the past few years. Don't be narrowminded.
The Fed is trying to tame inflation while not killing the stock market at the same time. It's a tough task for anyone but the current group of Fed Governers is definitely not up for the task.
It’s shocking how clueless the Fed was with “transitory inflation”. The Gov’t sent checks to anyone and everyone, even those that didn’t need it. The end result was an unprecedented spending spree and retail investor mania. It’s a shame that they F’d up so badly because I don’t believe the low rates were really the problem and now they have no choice but to raise. I think it was mainly the psychological effect of people receiving free money.
When you hear them speak they don't seem very bright but I find it impossible to believe they believed that transitory story. It was so obviously wrong.
Yea I realize but rate hike cycles usually lead to recession within 18 mos or so. I tend to think they won’t be able to thread the needle but we’ll see.
I do think low rates so low for so long were definitely part of the problem. Stimulus was just fuel to the fire. It was just more east money on top of what was already floating around.
I don't see what choice they have. If inflation continues at this high rate it would be even more crippling to the economy. They are going to get A LOT of political pressure before the midterms so its going to be hard to predict what they do before November.
We are probably already in a recession anyway.
They don’t have a choice with inflation being so high. I’m just wondering how high they will have to go.
So says Tom Lee's and Cathy Woods' "love child".... I kid.... I kid.....
Inflation would have been transitory without omicron and Putin. It has little to do with traditional monetary and economic issues.
Tom Lee is still the King of Kings! No doubt. CW's macro analysis is always interesting.
Trying to wriggle out of the deal?
Anyone up for a lottery ticket biotech play? I mentioned this one before, but this week is game time with the FDA. Bluebio has been crushed with countless delays. The stock is so beaten down that if they get approvals in a few months, it may 5x or more very quickly. Or if the FDA denies them again, they may go to $0. LOL!
Update article:
bluebird bio Blazes Trail for Lentiviral Vectors at Upcoming FDA AdComm | BioSpace | June 6, 2022
For the first time in half a decade, the U.S. Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee will convene June 9-10 to address two therapies developed by bluebird bio in back-to-back meetings sure to draw the eyes of all companies developing lentiviral vectors as potential therapeutics for rare diseases.
For Cambridge, MA-based bluebird, the two-day meetings will be a huge moment in a watershed year for the beleaguered company that laid off nearly one-third of its employees in April. Not only will the advisory committee help shape the future for beti-cel and eli-cel, gene therapies that are already marketed in Europe, it could likely shape the future of the trailblazing company.
“Next week is going to be monumental, quite frankly,” Melissa Bonner, head of research at bluebird bio told BioSpace. “This is the first time a lentiviral vector will be considered in the United States. This will have a profound impact on the entire field of gene therapy because there are a lot of different products in development that use an LVV approach.”
Like a spelunker carefully exploring a newly-discovered cave, the bluebird team, along with the scientists who make up the advisory committee, will be navigating new regulatory territory in gene therapy. Because the discussions that will be had this week as eli-cel and beti-cel are carefully examined will have ripple effects across the industry, Bonner predicted the committee meeting will be closely watched by other companies following a similar program path.
“Everyone will tune in with their popcorn to see how this is going,” she quipped.
Eli-cel, also known as elivaldogene autotemcel, will be the first bluebird program discussed by the advisory committee. Eli-cel was previously approved in Europe under the brand name Skysona. It was approved last year as a treatment for juvenile patients with early cerebral adrenoleukodystrophy (CALD), a serious neurological disorder caused by mutations in the ABCD1 gene. CALD typically develops in a juvenile around the age of 7. The rare, progressive, x-linked disorder is ultimately fatal but not before sending the patient into a vegetative state.
Eli-cel uses ex vivo transduction with the Lenti-D lentiviral vector to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells (HSC). The addition of the functional ABCD1 gene allows patients to produce the ALD protein, which is thought to facilitate the breakdown of very long-chain fatty acids, which cause the breakdown of myelin, the protective sheath around nerve cells in the brain.
Throughout the course of its development, eli-cel has shown positive efficacy. But, at the same time, there have been some safety concerns, which the FDA advisory committee members will likely discuss in detail. The eli-cel study was hit with a clinical hold last year over safety concerns after a patient treated with the gene therapy developed a rare form of cancer, myelodysplastic syndrome.
Bonner said the company has been transparent about the safety of eli-cel. Throughout its development, three patients developed a malignancy that was likely related to the gene therapy. Bonner said the safety issues will have to be weighed against the overall positive efficacy seen throughout clinical development. The advisory committee members are expected to “have a lively discussion” to determine if the overall benefits of eli-cel outweigh the risks in a patient population that has few options beyond an allogeneic stem cell transplant from a matched donor.
“If you have a matched donor, your odds are good. If not, your odds are very different,” she said. “This is a life-saving therapy. We think there’s a positive benefit-risk.”
On day two, the advisory committee will assess beti-cel, which is being developed for the blood disorder beta-thalassemia. Beti-cel is marketed as Zynteglo in Europe. Pointing to the clinical data, Bonner said with beti-cel there have not been the same safety concerns seen with eli-cel, and also noted that it has had positive efficacy data that she called “transformative.” Beti-cel is one-time gene therapy intended to treat beta-thalassemia in patients who need regular transfusions of red blood cells. In Phase III trials of beti-cel, 89% of patients who could be evaluated achieved transfusion independence.
As the advisory committee meeting looms closer, Bonner said the bluebird team will prepare as well as possible for all potential questions brought up by the committee members. While the meeting is a new experience for bluebird, Bonner noted this is also a new experience for the advisory committee members who have not met since the 2017 meeting before the approval of Spark Therapeutics’ Luxturna, a gene therapy for a rare form of blindness.
Although Bonner admitted the advisory committee meetings are stress-inducing, especially given the recent layoffs at bluebird, she shared her hope for the vast potential gene therapies have for rare disease patients. There are approximately 7,000 known rare diseases that impact between 25 million and 30 million Americans. The vast majority of those rare diseases do not have any therapeutic options or have insufficient ones.
“This type of technology (lentiviral vectors) can be pretty useful for these patients. That’s why this will be such a momentous occasion,” she said.
Update article:
bluebird bio Blazes Trail for Lentiviral Vectors at Upcoming FDA AdComm | BioSpace | June 6, 2022
For the first time in half a decade, the U.S. Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee will convene June 9-10 to address two therapies developed by bluebird bio in back-to-back meetings sure to draw the eyes of all companies developing lentiviral vectors as potential therapeutics for rare diseases.
For Cambridge, MA-based bluebird, the two-day meetings will be a huge moment in a watershed year for the beleaguered company that laid off nearly one-third of its employees in April. Not only will the advisory committee help shape the future for beti-cel and eli-cel, gene therapies that are already marketed in Europe, it could likely shape the future of the trailblazing company.
“Next week is going to be monumental, quite frankly,” Melissa Bonner, head of research at bluebird bio told BioSpace. “This is the first time a lentiviral vector will be considered in the United States. This will have a profound impact on the entire field of gene therapy because there are a lot of different products in development that use an LVV approach.”
Like a spelunker carefully exploring a newly-discovered cave, the bluebird team, along with the scientists who make up the advisory committee, will be navigating new regulatory territory in gene therapy. Because the discussions that will be had this week as eli-cel and beti-cel are carefully examined will have ripple effects across the industry, Bonner predicted the committee meeting will be closely watched by other companies following a similar program path.
“Everyone will tune in with their popcorn to see how this is going,” she quipped.
Eli-cel, also known as elivaldogene autotemcel, will be the first bluebird program discussed by the advisory committee. Eli-cel was previously approved in Europe under the brand name Skysona. It was approved last year as a treatment for juvenile patients with early cerebral adrenoleukodystrophy (CALD), a serious neurological disorder caused by mutations in the ABCD1 gene. CALD typically develops in a juvenile around the age of 7. The rare, progressive, x-linked disorder is ultimately fatal but not before sending the patient into a vegetative state.
Eli-cel uses ex vivo transduction with the Lenti-D lentiviral vector to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells (HSC). The addition of the functional ABCD1 gene allows patients to produce the ALD protein, which is thought to facilitate the breakdown of very long-chain fatty acids, which cause the breakdown of myelin, the protective sheath around nerve cells in the brain.
Throughout the course of its development, eli-cel has shown positive efficacy. But, at the same time, there have been some safety concerns, which the FDA advisory committee members will likely discuss in detail. The eli-cel study was hit with a clinical hold last year over safety concerns after a patient treated with the gene therapy developed a rare form of cancer, myelodysplastic syndrome.
Bonner said the company has been transparent about the safety of eli-cel. Throughout its development, three patients developed a malignancy that was likely related to the gene therapy. Bonner said the safety issues will have to be weighed against the overall positive efficacy seen throughout clinical development. The advisory committee members are expected to “have a lively discussion” to determine if the overall benefits of eli-cel outweigh the risks in a patient population that has few options beyond an allogeneic stem cell transplant from a matched donor.
“If you have a matched donor, your odds are good. If not, your odds are very different,” she said. “This is a life-saving therapy. We think there’s a positive benefit-risk.”
On day two, the advisory committee will assess beti-cel, which is being developed for the blood disorder beta-thalassemia. Beti-cel is marketed as Zynteglo in Europe. Pointing to the clinical data, Bonner said with beti-cel there have not been the same safety concerns seen with eli-cel, and also noted that it has had positive efficacy data that she called “transformative.” Beti-cel is one-time gene therapy intended to treat beta-thalassemia in patients who need regular transfusions of red blood cells. In Phase III trials of beti-cel, 89% of patients who could be evaluated achieved transfusion independence.
As the advisory committee meeting looms closer, Bonner said the bluebird team will prepare as well as possible for all potential questions brought up by the committee members. While the meeting is a new experience for bluebird, Bonner noted this is also a new experience for the advisory committee members who have not met since the 2017 meeting before the approval of Spark Therapeutics’ Luxturna, a gene therapy for a rare form of blindness.
Although Bonner admitted the advisory committee meetings are stress-inducing, especially given the recent layoffs at bluebird, she shared her hope for the vast potential gene therapies have for rare disease patients. There are approximately 7,000 known rare diseases that impact between 25 million and 30 million Americans. The vast majority of those rare diseases do not have any therapeutic options or have insufficient ones.
“This type of technology (lentiviral vectors) can be pretty useful for these patients. That’s why this will be such a momentous occasion,” she said.
Interested to see what these rules look like. Would be nice if they could actually fix this issue:
I’ll translate. I was high when I made the bid. Didn’t think anyone would hit me on the bid. Now I have to come up with BS excuse to back out of the deal.
Smart guy but his antics are tiring. Also "we're gonna layoff people, then we're not going to layoff" people...etc.
The best is that he keeps tweeting to all the “fake” accounts. you would think he gets off Twitter since it’s all bots.
I find some of the tweeting to be borderline, if not outright, manipulative. If you have the power to move markets or a stock with your words/tweets you have to be judicious in how do things.
S&P and VIX both finished in the green today. Usually spells a bumpy couple days to follow. One of the few technical artifacts that actually holds up time and again.
Musk is the epitome of a loose cannon. I can’t imagine working for him.
I remember reading an article that said Musk’s teenage kids were dabbling in crypto back during the Doge mayhem. Shocker…LOL. Im sure Musk (1) helped them make a fortune via his constant market manipulating Tweets; and (2) taught them that Daddy is basically a God with the ability to control the crypto tides.
Looks like TGT will be testing 52wk lows judging by the premarket. Surprising that they didn't know this just a few weeks ago during earnings. This kind of thing shouldn't be hitting the stock twice. There is some support in the 52wk low area, then 120-130, then 90-105.
I missed WMT by a little bit while I was away, we'll see if it comes to me on this in sympathy news. TGT could be interesting too. A lot of the froth of the last 2 years has come out of the stock.
Not a biotech lottery ticket but read about this over the weekend. Don't know that I'd be interested in LLY but what do you think about their diabetes drug showing promising results as a weight loss drug as well. Seems like a pretty big addressable market if it's as promising as it sounds.
With so many possible patients (i.e., fat people), tirzepatide could become the biggest medicine on the market. Think Lipitor 2.0. That's how good the clinical trial results are. The health benefits beyond weight loss are huge (which can be confirmed via additional trials to expand the indication and claims).
Also, since it just made it to market for the diabetes indication, I assume it has a long patent life ahead of it.....well into the 2030s.
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TGT holding steady so far bouncing off that 52wk low area I mentioned has some support. See if it can hold that through the day and in the coming days.
Some more promising news on the pharma front and the fight against cancer. GSK drug.
China’s top economist said CCP must seize Taiwan Semiconductor (TSMC) if America applies sanctions — additionally, CCP must stop all shipments of chip-making technology to US —-this cuts off our ability to build plants here in US. TSMC = AMD cpus etc