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Vinmantoo,
You were being very kind when you called Paxton a nutcase. …. Certainly not to the other nut cases in this world. 😊
A quick Google search on Paxton and fraud:
The Texas Tribune
www.texastribune.org
Ken Paxton moves one step closer to trial on long-delayed securities fraud charges
Aug 3, 2023 — In the criminal case, Paxton faces two counts of securities fraud, a first-degree felony with a punishment of up to 99 years in prison, stemming ...
AP News
apnews.com
Texas Attorney General Ken Paxton's securities fraud trial to wait until end of ...
Aug 3, 2023 — The indictments accuse Paxton of defrauding investors in a Dallas-area tech startup by not disclosing he was being paid by the company, called ...
Texas Attorney General (.gov)
https://texasattorneygeneral.gov › at...
Attorney General Ken Paxton Opens Investigation into Media Matters for ...
Nov 20, 2023 — The Office of the Attorney General (“OAG”) is opening an investigation into Media Matters for potential fraudulent activity
I just assumed that he was comparing different years. e.g. June 2020 with June 2022.
In 2022 you would have more people vaccinated but who would also have been sicker for much longer.
As long as you’re willing to compare apples with oranges, or just outright lie, you can make any asinine statement you so choose.
Unfortunately, Pfizer has to maintain a great relationship with all of the law enforcement agencies. Hopefully the press will give them a good ass kicking for the nonsense that he released in that PR.
Nothing in the press release seemed credible to me. No Pfizer employee nor job position was named. No numerical facts were given.
No credible source for Pfizer supposed misdeed was identified
I would suspect the Texas Attorney General is more likely to be guilty of violating the law than Pfizer.
FWIW
Ian
Is the following “dirty tricks“ by some country such as Russia, China, or Iran, or North Korea? I suspect it would be impossible for any pharmaceutical company to get away with such tactics, if going for a full approval from the FDA. However, I do not know enough about the EUA to know whether or not, there’s even a remote possibility of this happening during that process???
===================================
Pfizer Faces Legal Action From Texas Attorney General Over COVID Vaccine
2023-11-30 03:59:08 PM ET (MT Newswires)
03:59 PM EST, 11/30/2023 (MT Newswires) -- Pfizer (PFE) faces lawsuit from Ken Paxton, the Texas Attorney General, for allegedly "unlawfully misrepresenting" how well its COVID-19 vaccine works and for attempts to stop people from talking openly about it, the Office of the Texas AG said Thursday.
"Pfizer engaged in false, deceptive, and misleading acts and practices by making unsupported claims regarding the company's COVID-19 vaccine in violation of the Texas Deceptive Trade Practices Act," according to the press release.
Pfizer's claim that its vaccine was 95% effective is highly misleading. In reality, it didn't live up to that. After widespread vaccination, COVID-19 cases increased, and some places saw more deaths among the vaccinated than the unvaccinated.
"We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies," Paxton said.
Neither the Attorney General's office nor Pfizer immediately responded to comment requests by MT Newswires.
Price: 30.33, Change: +0.25, Percent Change: +0.85
Has Revance made sufficient sales to show any benefit from the trade secret?
=========================
it was also not nearly optimistic enough given the strength of the products and the current share price.
===================================
And how happy would you be if management over promises then under delivers, and gets to spend its cash reserve defending itself from the resulting class action lawsuits?
Management is walking a tight rope. One misstep, and the shares could plummet again. IMHO.
At this time, mutual funds which hold RVNC will be sellers. In an earlier message, I said, ETFs. That’s wrong. ETFs can’t pick and choose.
Agreed for those who wish to buy back their shares before year end.
Probably not true for those who decided they never want to hold Revance ever again
In addition to tax loss selling, any ETF that expects its year end price to show a loss, will sell all the shares rather than report a year end loss to all of its holders.
I suspect it’s far too early to average down, or to start a new position in RVNC.
If you go to Pubmed and search on NSAIDs and flu shots, you’ll discover that the aspirin has been interfering with the effectiveness of any vaccines you’ve had since you were in your 40s unless you stopped the aspirin about a week before and the week after the vaccine. …. Or just Google “pubmed NSAIDS and flu shot”.
Prior to turning 50 I lived a mostly sedentary lifestyle. After reading an abstract that originated from a Texas university, or Medcenter, I started taking two Advil daily after running. The abstract led me to believe that this was key to building muscles after exercise. My doctor discovered that my IgG, IgA and 2 others were below normal with the IgG being less than half the low end of the normal value. This immune deficiency cleared up after I stopped taking Advil.
Anecdotal. However, I’ve seen the same immunodeficiencies in everyone who I knew was chronically taking an NSAID.
Jim,
Re the brain fog:
My youngest sister who had MS complained of this. Taking omega-3 that was high in DHA cleared up the fog. Several years later she complained about the fog again. I asked if she was still taking omega-3. She said, no, resumed it, and the fog disappeared again.
My girlfriend, who came down with GBS, and spent about three weeks in Sunnybrook, of which 10 days were in the ICU also complained of a brain fog once she was able to speak again. I got her a highly purified version of DHA extracted from flaxseed which also seemed to clear up the brain fog. As she had the Miller- Fisher variant of GBS, complete recoveries are not rare.
Both are anecdotal. Nevertheless, I do believe that the DHA was instrumental in clearing up the brain fog.
Caution about your friend taking aspirin chronically. Everyone I know that has taken any NSAIDS chronically has destroyed their immune system. (Myself included). The good news: when you stop taking the NSAIDs, your immune system recovers.
Once the NSAIDs issue makes it to the courts, I suspect that big Pharma is going to make big tobacco look as if they were saints.
If wishes were horses, beggars would ride
Where does the decimal point go?
If you follow the Wikipedia link, the accident had absolutely nothing whatsoever to do with overweight passengers. Rather, it has everything to do with an utterly incompetent, airline and all maintenance functions associated with the aircraft.
NTSB News Release
National Transportation Safety Board Office of Safety Recommendations and Communications
Loss of Pitch Control Caused Fatal Airliner Crash in Charlotte, North Carolina Last Year
2/26/2004
The National Transportation Safety Board determined today that the probable cause of an airliner crash in Charlotte, North Carolina, last year was the airplane's loss of pitch control during takeoff. The loss of pitch control was the result of incorrect rigging of the elevator control system compounded by the airplane's center of gravity, which was substantially aft of the certified aft limit.
"This accident shows how important it is for everyone involved in the safety chain to do their jobs properly, " said NTSB Chairman Ellen Engleman-Conners. "It is imperative that the recommendations we've issued today be implemented so that tragedies like this not be repeated."
On January 8, 2003, Air Midwest (doing business as US Airways Express) flight 5481, a Raytheon (Beechcraft) 1900D, N233YV, crashed shortly after takeoff from runway 18R at Charlotte-Douglas International Airport. Two crewmembers and 19 passengers aboard the airplane were killed. One person on the ground received minor injuries, and the airplane was destroyed by impact forces and a postcrash fire.
Contributing to the cause of the accident, the Board found, were Air Midwest's and the Federal Aviation Administration's (FAA) lack of oversight of the work being performed at Air Midwest's maintenance facility in Huntington, West Virginia. Board investigators found that the accident airplane entered a maintenance check with an elevator control system that was rigged to achieve full elevator travel in the downward direction. However, the airplane's elevator control system was incorrectly rigged during maintenance, and the incorrect rigging restricted the airplane's downward elevator travel to about one-half of the travel specified by the airplane manufacturer.
Air Midwest contracted with Raytheon Aerospace to provide quality assurance inspectors, among other maintenance personnel, for the Huntington maintenance station. Raytheon Aerospace contracted with Structural Modification and Repair Technicians to supply the m
We’ve still got three months of tax loss selling; and somewhere between 21 and 36 years of long-term interest rates rising.
These could be overruled if we get a blockbuster pre-announcement or a blockbuster quarterly report. I still doubt that Allergan/Abbvie will roll over and play dead.
For the last two centuries, each up or down leg for the long bond varied from 21 to 36 years. For the last century, the long bond was 30 years. In the prior century, it was either 20 or 30 years.
I’m still half asleep and left out the key point.
They were forced to replace the toxin that they were using to generate their production supply
My WAG is that this is just a follow on from the CRL. They probably have not regained significant production capacity.
Just a WAG. I have no facts nor inside information that lets me know the real answer.
IMO, the board would’ve already fired him if he was sitting on unused capacity while the stock plummeted from above 30 and is heading toward below 10.
I should live so long
Harry, I haven’t seen any buyout rumours for Acadia since March 2015. What are you talking about or hoping for?
Please provide a link.
If you have an iPhone with the stocks app pre-installed, you can read seeking Alpha articles.
Pfizer Paxlovid efficacy lower in real-world study
A new observational study based on real-world data has found that the efficacy of Pfizer's (NYSE:PFE) COVID-19 antiviral Paxlovid is not as strong as seen in earlier studies.
In particular, the new study, published in JAMA Network Open, showed that Paxlovid was 37% effective in preventing hospitalization or death in high-risk patients compared to those on placebo. However, prior studies had shown a effectiveness in this population as high as 89%.
It is important to note that the earlier studies conducted by Pfizer (PFE) were in an unvaccinated population, which could have impacted results.
The new study also looked at Merck's (MRK) COVID antiviral Lagevrio (molnupiravir) and found it led to a 41% reduction in hospitalizations and death compared to placebo.
The study was conducted based on the medical records of ~69K patients in Florida and Ohio.
More on Pfizer
Here’s an enthusiastic forecast.
DJ Advanced Micro Devices Price Target Maintained With a $200.00/Share by Rosenblatt
2023-09-20 11:34:00 AM ET (FW)
I didn’t see a day month or year for that target.
In the message that I am responding to, I predicted a price in the $12-$10 range. I did not expect that before tax loss selling season this year.
At this time I have no idea where the bottom might be or when it might get there. While I had intended to sell naked puts that were already ITM with a view to establishing a full position in RVNC, I no longer believe that this is a reasonable investment. Rather it’s a very risky speculation.
Nevertheless, I do hope that those who’ve established long positions fare very well. however, Foley is a bigger risk then I had anticipated, and may be more of an obstacle than a blessing.
IMO
Ian
This strikes me as a “wow!“ result. Am I missing something?
Exelixis Announces Positive Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
2023-08-24 08:00:08 AM ET (BusinessWire)
--- Based on positive results, findings will be discussed with the U.S. Food and Drug Administration -
Exelixis, Inc. (Nasdaq: EXEL) today announced that the Alliance for Clinical Trials in Oncology independent Data and Safety Monitoring Board (DSMB) unanimously recommended to unblind and stop the phase 3 CABINET pivotal trial early due to a dramatic improvement in efficacy that was observed at an interim analysis. CABINET is evaluating cabozantinib (CABOMETYX(R)) compared with placebo in patients with either advanced pancreatic neuroendocrine tumors (pNET) or advanced extra-pancreatic neuroendocrine tumors (also referred to as carcinoid tumors) who experienced progression after prior systemic therapy. Cabozantinib substantially prolonged the time without disease progression or death in both of the trial's cohorts. CABINET is sponsored by the National Cancer Institute (NCI) and is led by The Alliance for Clinical Trials in Oncology. Detailed findings will be presented at an upcoming medical meeting and discussed with the U.S. Food and Drug Administration (FDA).
"As there is no standard of care for patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors whose disease has progressed after prior therapy, we are pleased to see that cabozantinib improved outcomes for two additional patient populations living with advanced, difficult-to-treat cancers," said Will Berg, M.D., Senior Vice President, Medical Affairs, Exelixis. "We are grateful for the recommendation of the Data and Safety Monitoring Board to unblind the CABINET study early due to a dramatic improvement in efficacy and look forward to discussing these findings with the U.S. Food and Drug Administration."
The safety profile of cabozantinib observed in the trial was consistent with its known safety profile, and no new safety signals were identified.
"Patients with progressive neuroendocrine tumors have limited treatment options. At present, after progression on previous therapies, the treatment path is unclear, underscoring the need for additional options for this disease that is rising in incidence," said Jennifer Chan, M.D., M.P.H., study chair for the CABINET trial and Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute. "These promising findings from the CABINET trial, in which cabozantinib showed an efficacy benefit for patients with pancreatic and extra-pancreatic neuroendocrine tumors, are welcome news and show the potential for cabozantinib to address important unmet needs for this community."
About CABINET (A021602)
CABINET (Randomized, Double-Blinded Phase III Study of CABozantinib versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Prior Therapy) is sponsored by the NCI, part of the National Institutes of Health, and is being led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCI-funded National Clinical Trials Network as part of Exelixis' collaboration with the NCI's Cancer Therapy Evaluation Program. CABINET is a multicenter, randomized, double-blinded, placebo-controlled phase 3 pivotal trial that enrolled a total of 290 patients in two separate cohorts (pNET, n=93; extra-pancreatic NET, n=197) in the U.S. Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression after at least one FDA-approved line of prior therapy other than somatostatin analogs. The primary endpoint was progression-free survival in each cohort. Upon confirmation of disease progression, patients were unblinded, and those receiving placebo were permitted to cross over to open-label therapy with cabozantinib. Secondary endpoints included overall survival, radiographic response rate and safety. More information about this trial is available at ClinicalTrials.gov.
About NET
NET refer to cancers that begin in the specialized cells of the body's neuroendocrine system.(1) These cells have traits of both hormone-producing endocrine cells and nerve cells.(1) In the U.S., more than 12,000 people are diagnosed with NET each year and approximately 171,000 people are living with the disease.(2) The number of people diagnosed with NET each year has been increasing.(2) NET are classified as functional or non-functional.(1) Functional NET release peptide hormones that can cause debilitating symptoms and necessitate treatment, while symptoms of non-functional NET are related primarily to tumor growth.(1,3,4) Most NET take years to develop and grow slowly, but some grow quickly.(5) NET can develop in any part of the body, but most commonly start in the gastrointestinal (GI) tract or in the lungs - these historically have been referred to as carcinoid tumors.(5) The five-year survival rates for advanced GI-NET and lung carcinoid tumors are 68% and 55%, respecti vely.(6,7) NET can also start in the pancreas.(8) While less common, these NET can be more aggressive and the five-year survival rate for advanced pNET is only 23%.(8,9) Surgery to remove the tumor and prevent it from spreading is the typical first approach to treatment for both carcinoid tumors and pNET.(10) For more advanced disease, options include somatostatin analogs, targeted therapy, peptide-receptor radionuclide therapy and chemotherapy.(10)
About CABOMETYX(R) (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (RCC); for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
CABOMETYX is not indicated as a treatment for NET.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage and prior to surgery as recommended. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.
Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.
Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.
Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.
Diarrhea: Diarrhea occurred in 62% of CABOMETYX patients. Grade 3 diarrhea occurred in 10% of CABOMETYX patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to less-than or equal to Grade 1, resume at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 45% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.
Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.
With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade greater-than or equal to2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade greater-than or equal to2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade greater-than or equal to2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab. Withhold and resume at a reduced dose based on severity.
Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity.
Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.
Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.
Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to less-than or equal to Grade 1 proteinuria, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome.
Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution, resume at a reduced dose.
Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Thyroid Dysfunction: Thyroid dysfunction, primarily hypothyroidism, has been observed with CABOMETYX. Based on the safety population, thyroid dysfunction occurred in 19% of patients treated with CABOMETYX, including Grade 3 in 0.4% of patients.
Patients should be assessed for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitored for signs and symptoms of thyroid dysfunction during CABOMETYX treatment. Thyroid function testing and management of dysfunction should be performed as clinically indicated.
Hypocalcemia: CABOMETYX can cause hypocalcemia. Based on the safety population, hypocalcemia occurred in 13% of patients treated with CABOMETYX, including Grade 3 in 2% and Grade 4 in 1% of patients. Laboratory abnormality data were not collected in CABOSUN.
In COSMIC-311, hypocalcemia occurred in 36% of patients treated with CABOMETYX, including Grade 3 in 6% and Grade 4 in 3% of patients.
Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity.
Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.
ADVERSE REACTIONS
The most common (greater-than or equal to20%) adverse reactions are:
CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.
CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John's wort.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.
Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.
Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
About Exelixis
Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by bi-coastal centers of discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX(R) (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on Twitter, like Exelixis, Inc. on Facebook and follow E xelixis on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of cabozantinib to reduce the risk of disease progression or death for patients with advanced pancreatic neuroendocrine tumors or advanced extra-pancreatic neuroendocrine tumors who experienced progression after prior systemic therapy; Exelixis' plans to discuss the trial data from CABINET with the U.S. Food and Drug Administration; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' continuing compliance with applicable legal and regulatory requirements; Exelixis' dependence on its relationships with its cabozantinib commercial collaboration partners; Exelixis' dependence on third-party vendors for the development, manufacture and supply of cabozantinib; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of CABOMETYX; changes in economic and business conditions; and other factors affecting Exelixis and its development programs discussed under the caption "Risk Factors" in Exelixis' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 1, 2023 and Annual Report on Form 10-K filed with the SEC on February 7, 2023, and in Exelixis' future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.
Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.
(1) Neuroendocrine Tumors: Introduction. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/neuroendocrine-tumors/introduction. Accessed August 2023. (2) Neuroendocrine Tumors: Statistics. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/neuroendocrine-tumors/statistics. Accessed August 2023. (3) Pancreatic Neuroendocrine Tumors (Islet Cell Tumors) Treatment (PDQ(R))-Patient Version. NCI website. Available at: https://www.cancer.gov/types/pancreatic/patient/pnet-treatment-pdq. Accessed August 2023. (4) Neuroendocrine Tumors: Types of Treatment. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/neuroendocrine-tumors/types-treatment. Accessed August 2023. (5) Neuroendocrine Tumor of the Gastrointestinal Tract: Introduction. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/neuroendocrine-tumor-gastrointestinal-tract/introduction. Accessed August 2023. (6) Survival Rates for Gastrointestinal Carcinoid Tumors. ACS website. Available at: https://www.cancer.org/cancer/types/gastrointestinal-carcinoid-tumor/detection-diagnosis-staging/survival-rates.html. Accessed August 2023. (7) Survival Rates for Lung Carcinoid Tumors. ACS website. Available at: https://www.cancer.org/cancer/types/lung-carcinoid-tumor/detection-diagnosis-staging/survival-rates.html. Accessed August 2023. (8) Neuroendocrine Tumor of the Pancreas: Statistics. Cancer.Net website. Available at: https://www.cancer.net/cancer-types/neuroendocrine-tumor-pancreas/statistics. Accessed August 2023. (9) Survival Rates for Pancreatic Neuroendocrine Tumor. ACS website. Available at: https://www.cancer.org/cancer/types/pancreatic-neuroendocrine-tumor/detection-diagnosis-staging/survival-rates.html. Accessed August 2023. (10) Neuroendocrine Tumor (NET). NCI website. Availably at: https://www.cancer.gov/pediatric-adult-rare-tumor/rare-tumors/rare-endocrine-tumor/carcinoid-tumor. Accessed August 2023.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230823099737/en/
SOURCE: Exelixis, Inc.
$NVAX up almost 20% during the day on apparently pure bullshit. According to seeking Alpha, it was a very small study in my story and nonhuman primates unknown numbers whatsoever were provided.
From a general Health PR:
(Adds details on rival COVID-19 shots in paragraph 3)
Aug 22 (Reuters) - Novavax Inc said on Tuesday its updated protein-based COVID-19 vaccine generated an immune response against emerging forms of coronavirus such as the "Eris" subvariant in small studies in animals.
COVID infections and hospitalizations have been rising in the United States, Europe and Asia, with more cases in recent months attributed to the EG.5 subvariant — nicknamed "Eris" — a descendant of the Omicron lineage that originally emerged in November 2021.
For the fall season, COVID vaccine makers are gearing up with updated shots that target the Omicron subvariant XBB.1.5. Both Moderna and Pfizer have said their shots show promise against Eris too.
Vinman, RVNC is going up, against a very experienced, very professional, established salesforce. They have faced competitors before and fared very well.
I wouldn’t be surprised to see RVNC in the $10-$12 range again. To the extent that its salesforce is able to deliver product to end customers and the end customers see the significant advantages that due diligence does, substantial price gains above the 30s are definitely possible.
At this time, there’s still uncertainty.
JMHO
Ian.
My guess is that Revance has gone through the transition from being an emerging biotech with a price based upon wishes dreams, and High Hopes to being an established biotech, whose price is based upon actual earnings and ROI.
The CD stream will not begin before next year. And with what the market has learned about the aesthetic stream, that’s going to be a very slow build up.
In Canada I would pay $200 a month if I had no insurance whatsoever for Ozempic. Between my government insurance for seniors, and my private insurance, I pay nothing. The US charge for Ozempic is outrageous.
My doctor started me at .25 mL for the first week. I went from being always ravenous to having almost no appetite whatsoever. I lost a little over 25 pounds in my first week. I reviewed this with my doctor and rather than stopping Ozempic. We agreed that I carry on that to .25 mL a week rather than going to the recommended dosage of .5 mL weekly.
After about nine months, my appetite started to return. My weight started to go up, and my random glucose to also started to rise again. My doctor and I agreed that I would take the .5 mL weekly dose but do it in two steps of .25 mL each. I did that for about a year before going to the Louisville recommended dosage of .5 mL once weekly.
I’ve had almost no side effects. If I go for a walk, I have involuntary burping, which is quite loud and probably shocks other pedestrians. …. Some increase flatulence.
I’m now starting to regain my appetite after having lost close to 60 pounds during the past couple years. I haven’t yet talked to my doctor to see what he wants to do with the dosage.
All in all, Ozempic has been extraordinarily effective, almost side effect free, and has clearly exceeded any expectations that I had.
From its sales and demand for this drug, I suspect that most people are affected the way I have been rather than the way most of the people commenting on this thread, have experienced.
Ian
Short term: down
Long-term: up
The latest rally seems to of been driven by a misinterpretation of Intel’s latest quarterly report.
All three business sectors driven by chips, head losses. The only sector with a profit of 305% was the foundry business.
And I suspect that that’s because all of the costs for the foundry have already been assigned to the chip sectors that they’re originally designed to produce. The street is not stupid. They will be only too happy to take all the money that the retail investor wants to give them but I do expect the recent rally to be wiped out before chip demand justifies a substantial gain.
JMHO,
Ian
This is an uninformed opinion as I’ve never owned Intel and I’ve never done any rigourous due diligence. Only once have I sold naked puts which expired worthless.
Make that billion, million is barely more than a rounding error.
Last I heard, four people were injured.
Severity of injuries was not mentioned.
Shares of Acadia climbed 17% in after-hours trading Thursday.
Price: 30.25, Change: +4.45, Percent Change: +17.25
ACADIA Pharmaceuticals Acquires Ex-North America Rights to Trofinetide, Global Rights to NNZ-2591; Shares Rise After Hours
2023-07-13 05:26:11 PM ET (MT Newswires)
05:26 PM EDT, 07/13/2023 (MT Newswires) -- ACADIA Pharmaceuticals (ACAD) said Thursday it expanded its current licensing agreement for trofinetide, a treatment for Rett syndrome, with Neuren Pharmaceuticals to acquire ex-North American rights to the drug.
The agreement also gives Acadia global rights to Neuren's NNZ-2591 in Rett syndrome and Fragile X syndrome.
Under the agreement, Neuren will receive an upfront payment of $100 million and may receive potential downstream milestone and royalty payments earned separately for trofinetide and NNZ-2591.
Outside of North America, Neuren may receive additional payments for trofinetide upon the achievement of certain revenue milestones and it will also get tiered royalties from the mid-teens to low-twenties percent of trofinetide sales.
Potential future payments to Neuren related to NNZ-2591 in Rett syndrome and Fragile X syndrome are equal to the payments for trofinetide in each of North America and outside North America, Acadia said.
Acadia said it plans to submit a new drug submission for trofinetide in Canada in the next 18 months. It will announce plans for Europe, Asia and other regions at a later date.
Shares of Acadia climbed 17% in after-hours trading Thursday.
Price: 30.25, Change: +4.45, Percent Change: +17.25
ELOX up more than 100% after hours, possibly based on publishing the following: (note that the paper does not refer to anything being done in VIVO)
Eloxx Pharmaceuticals Announces Publication Demonstrating the Power of its TURBO-ZM™ Platform to Target the Human Ribosome for Therapeutic Benefit
Publication titled “A Novel Class of Ribosome Modulating Agents Exploits Cancer Ribosome Heterogeneity to Selectively Target the CMS2 Subtype of Colorectal Cancer” published in Cancer Research Communications??
Results suggest that MYC overexpressing cancers can be targeted by exploiting ribosome heterogeneity in cancer; preclinical data demonstrated activity of ZKN-157 against subtypes of colorectal cancer
Research potentially opens large opportunities to selectively target MYC-driven cancers with a novel mechanism and possible synergy with existing cancer therapies
WATERTOWN, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that Cancer Research Communications has published “A Novel Class of Ribosome Modulating Agents Exploits Cancer Ribosome Heterogeneity to Selectively Target the CMS2 Subtype of Colorectal Cancer”. The publication demonstrates the potential of Eloxx’s TURBO-ZM chemistry technology platform to develop novel Ribosome Modulating Agents (RMAs) and details preclinical data that demonstrate activity for ZKN-157 against subtypes of colorectal cancer.
“We are incredibly pleased with this publication, as it highlights the power of our TURBO-ZM platform to target the human ribosome to develop new potential therapeutics. Importantly, for the first time, we also demonstrate that MYC overexpressing cancers can be targeted by exploiting ribosome heterogeneity, as ZKN-157, a novel RMA, demonstrated activity against subtypes of colorectal cancer,” said Vijay Modur MD, PhD, Head of R&D of Eloxx. “As MYC is dysregulated in approximately 70% of human cancers, this research provides opportunities to selectively target MYC-driven cancers with a novel mechanism and has potential for synergy with existing cancer therapies.”
Eloxx uses a unique synthetic chemistry approach to generate novel RMAs that exploit cancer ribosome heterogeneity. ZKN-157 was designed to selectively target the consensus molecular subtype 2 (CMS2) of colorectal cancer, which is distinguished by high MYC activity. In the preclinical data published, ZKN-157 showed efficacy as a single agent and, the potency and efficacy of ZKN-157 synergized with clinically approved DNA-intercalating agents, which have previously been shown to inhibit ribogenesis as well.
The publication is available on Eloxx’s website at link.
About Eloxx Pharmaceuticals
Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM™ chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in Phase 2 clinical development for the treatment of Alport syndrome in patients with nonsense mutations. For more information, please visit www.eloxxphar
Lisa Su is like Wayne Gretzky. Her AI shot will be where the puck is going, not where it is or was.
I certainly hope you’re right. However, I don’t believe it’s slam dunk.
NVDA sells the complete package software and the chips.
AMD may well have superior chips, but they need much better software to allow developers to more easily take full advantage of the power in those chips.
Lisa Su is well aware of the requirement, and I have every confidence that she will deliver. I just don’t know when.
And another price increase. …
Alert Sent 2023-06-12 09:44:25 AM ET
Delivery preference: Immediate delivery
UBS Raises Advanced Micro Devices' Price Target to $155 From $95, Maintains Buy Rating
2023-06-12 09:43:44 AM ET (MT Newswires)
09:43 AM EDT, 06/12/2023 (MT Newswires) -- Advanced Micro Devices (AMD) has an average rating of Outperform and price targets ranging from $77 to $200, according to analysts polled by Capital IQ.
(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)
Price: 128.76, Change: +3.84, Percent Change: +3.07
Alert Sent 2023-06-12 07:47:23 AM ET
Keybanc Adjusts Price Target on Advanced Micro Devices to $150 From $110, Maintains Overweight Rating
2023-06-12 07:46:01 AM ET (MT Newswires)
07:46 AM EDT, 06/12/2023 (MT Newswires) -- Advanced Micro Devices (AMD) has an average rating of outperform and price targets ranging from $77 to $200, according to analysts polled by Capital IQ.
(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)
Price: 128.66, Change: +3.74, Percent Change: +2.99
Alert Sent 2023-06-12 08:41:42
Wedbush Adjusts Price Target on Advanced Micro Devices to $145 From $95, Maintains Outperform Rating
2023-06-12 08:41:06 AM ET (MT Newswires)
08:41 AM EDT, 06/12/2023 (MT Newswires) -- Advanced Micro Devices (AMD) has an average outperform rating and a price target range of $77 to $200, according to analysts polled by Capital IQ.
(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)
Price: 128.89, Change: +3.97, Percent Change: +3.18
This news release may be of interest to the thread.
I can’t figure out how to bold text on my iPhone, so I have repeated the text here
=================================
semiconductor sector short sellers are down 36.3% on an average short interest of $50.5 billion for the year so far, with 63% of every stock shorted in the sector unprofitable and 92% of every dollar shorted a losing trade.
Nvidia has had the largest increase in short covering in the past 30 days, while Advan ced Micro Devices has had the largest increase in short selling in that period.
==================================
Semi shorts down $18 billion in mark-to-market losses in 2023, S3 Partners says
2023-06-01 01:03:23 PM ET (Reuters)
NEW YORK, June 1 (Reuters) - Short sellers in U.S. shares related to the semiconductor industry are down $18.31 billion in mark-to-market losses for the year to date, including $7.2 billion in losses since last week's rally in Nvidia's stock , according to financial data firm S3 Partners.
Nvidia's shares are up about 28% since May 24, when the graphics chipmaker gave its blowout forecast after the bell. The PHLX semiconductor sector index gained roughly 15% in May and hit an over one-year high.
"The Semiconductor sectors have been an investing desert for short sellers," S3 Partners analysts wrote in the report this week.
They added that semiconductor sector short sellers are down 36.3% on an average short interest of $50.5 billion for the year so far, with 63% of every stock shorted in the sector unprofitable and 92% of every dollar shorted a losing trade.
Nvidia has had the largest increase in short covering in the past 30 days, while Advan ced Micro Devices has had the largest increase in short selling in that period.
In addition, S3 cited Marvell Technology Inc, Broadcom Inc and Ambarella Inc among stocks prone to a short squeeze.
"We expect short covering in these stocks as short sellers look to trim their exposure and limit future mark-to-market losses if these stocks continue to rally," S3 analysts said.
(Reporting by Caroline Valetkevitch; editing by Lance Tupper and Will Dunham)
You seem to be a quant focus solely on price versus either sales or earnings.
I’ve never seen you post any fundamental or technical analysis just harping on AMD is priced too high.
Pardon me, but I prefer to work from a thorough understanding of the fundamentals. This thread seems to be focussed primarily on technical.
You seem to be focussed on price alone. From my experience, that’s a great way to lose money rapidly.
FWIW,
Ian.
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Re: Buying here? Doubt that anyone who wants in, like myself, is looking at this thinking it's a good time to buy.
==============================
Before the Fed induced sell off, NVDA had a market cap greater than that of INTC and AMD combined.
Today NVDA has a market cap of 0.963T, AMD has a market cap 0.204T, and INTC has a market cap of 0.121T
Why do I suspect you would’ve bought INTC last year when each of these companies was approaching its high?
So what if it has trailing edge fabs, trailing edge chips, and a strategy which lasts until the next major news headline???