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2025-01-21
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spin ph pba live Châtillon, France, December 11 th , 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 - 3 Years-Old "DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 - 3-years-old. This comes on the heels of our October 22 nd press release announcing details in support of our separate Viaskin Peanut programs in 4 - 7 year-olds and in 1 - 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. "We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.” Accelerated Approval Pathway The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 - 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria: FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company's Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval. In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient's skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location. Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study. Post-Marketing Confirmatory Study In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 - 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial. The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling. "When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). "I'm pleased to learn that DBV's constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.” COMFORT Toddlers Supplemental Safety Study COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 - 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study. "I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. "Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.” The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 - 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers. As previously disclosed , DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA: Biologic License Application Submission in 1 - 3 Year-Olds There will be two Phase 3 studies in 1 - 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission: Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today, Wednesday, December 11 th , at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPITTM), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin's immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company's food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company's ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn . Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPITTM, designs of DBV's anticipated clinical trials, DBV's planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to COMFORT Toddlers and COMFORT Children, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, DBV's expectations with respect to the Accelerated Approval pathway and any other actionable regulatory pathway, and the ability of any of DBV's product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV's product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV's ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV's regulatory filings with the French Autorité des Marchés Financiers ("AMF”), DBV's filings and reports with the U.S. Securities and Exchange Commission ("SEC”), including in DBV's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies [email protected] Media Contact Angela Marcucci DBV Technologies [email protected] Attachment PDF Version( MENAFN - AFP) As President-elect Donald trump vows sweeping tariffs on even America's close partners once in office, US wine merchants and restaurateurs are watching with trepidation -- and pushing for exclusions they say will protect small businesses. "A lot of our concern is that he could flip the switch on EU tariffs. They were suspended, but not eliminated," said chef DeWayne Schaaf, owner of Celebrations Restaurant in Missouri. On the campaign trail, Trump threatened blanket tariffs of at least 10 percent on all imports, but the shadow of even higher levies from US-Europe disputes during his first term hangs over businesses. Either scenario would likely thin their profits and force them to raise prices. In 2019, Trump imposed a 25 percent tariff on popular European food, drinks and other products as Washington and Brussels clashed over European Union subsidies to aircraft maker Airbus. "We were absolutely shocked," US Wine Trade Alliance president Ben Aneff told AFP. The tariffs were suspended after President Joe Biden and the EU in 2021 reached a five-year truce. EU Ambassador to the US Jovita Neliupsiene told reporters this month that she did not see interest from the bloc in threatening this truce, and that its future is very much in the US's hands. Now, US wine traders and restaurant owners are waiting with bated breath for Trump's new plans. "We hope that there would be exclusions for products that are especially important to American small businesses," Aneff said. - 'Crippling' - Businesses say a 10 percent universal tariff could be absorbed by industries initially, but would eventually increase consumer prices and weigh heavily on smaller establishments, including many restaurants. If across-the-board tariffs on imports were imposed over a long period, Schaaf anticipates having to cut staff hours, pull back on wine offerings, or reduce business hours. Should Washington reintroduce 25 percent levies on European food and wines, the situation would be "crippling to many, myself included," added the chef, who employs two dozen staff. Noah Bush, proprietor of GB Provisions in Oklahoma, told AFP: "Eventually, in order to stay open, those tariffs are going to have to move on to the guests." For now, he said he would stock up on European wines. Schaaf said one of his business partners bought 10 containers of wine in anticipation of Trump's possible tariffs -- hoping to get them to US shores before new levies hit. "Wine and alcohol are big, big moneymakers in the restaurant business," Bush said. Due to 2019 tariffs, he lost some 10 percent in European wine sales and reduced staff hours to sustain operations. Schaaf said restaurants like his had no involvement in the trade dispute that triggered duties -- "yet we were the ones who bore the brunt." - 'Ineffective' - On the campaign trail, Trump took aim at US-EU trade imbalances, particularly in autos and agriculture. "They don't take our cars. They don't take our farm products. They sell millions and millions of cars in the United States," he said, warning that the bloc would "have to pay a big price." Analysts expect the eurozone would be hit hard if Trump followed through on sweeping tariff hikes. Aneff, who is also managing partner of retailer Tribeca Wine Merchants, argues that targeting imported wine would be an "incredibly ineffective way" to remedy trade with Europe. He said tariffs on wine imports do more harm to US firms, impacting profits along the import and distribution supply chains. And there is "zero possibility that producers in Europe would offset tariffs" by lowering prices, he added. Dartmouth College economics professor Douglas Irwin said US president Richard Nixon imposed a 10 percent across-the-board tariff in the 1970s, but it caused little disruption as Japan and Europe were willing to negotiate and did not retaliate. This may not be the case for Trump, he added. Based on precedent, other countries could strike back, sparking a trade war. MENAFN30112024000143011026ID1108942148 Legal Disclaimer: MENAFN provides the information “as is” without warranty of any kind. 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By Dalia Faheid , Michelle Watson , Bonney Kapp , John Miller and Dakin Andone , CNN The 3D-printed gun that healthcare CEO killing suspect Luigi Mangione had when he was arrested this week in Pennsylvania matches three shell casings found at the crime scene in Midtown Manhattan, the New York Police Department commissioner said Wednesday, as authorities continue to investigate the motive for the killing. Also, Mangione's fingerprints match those investigators found on items near the scene of the December 4 assassination of the UnitedHealthcare chief, Commissioner Jessica Tisch said at a public event. Three 9 mm shell casings from the crime scene had the words "delay," "deny" and "depose" written across them , one word per bullet, NYPD's Chief Detective Joseph Kenny has said. Police have been looking into whether the words, which title a 2010 book critiquing the insurance industry, may point to a motive in CEO Brian Thompson's killing . "First, we got the gun in question back from Pennsylvania. It's now at the NYPD crime lab," Tisch, the commissioner, said Wednesday. "We were able to match that gun to the three shell casings that we found in Midtown at the scene of the homicide." "We're also at the crime lab able to match the person of interest's fingerprints with fingerprints that we found on both the water bottle and the KIND bar near the scene of the homicide in midtown," she said. Authorities had been probing DNA material and a partial fingerprint from a discarded Starbucks water bottle and an energy bar wrapper surveillance images showed the suspect buying about 30 minutes before the shooting. The fingerprints were the first positive forensic match tying Mangione directly to the scene where Thompson was gunned down just over a week ago outside a hotel, two law enforcement officials briefed on the matter told CNN earlier Wednesday. CNN has reached out to Mangione's attorney for comment on what police have said about the shell casing and fingerprint matches. The killing of Thompson - a husband and father of two - has laid bare many Americans' fury toward the health care industry, with Mangione garnering sympathy online and offers to pay his legal bills. It's also struck fear in C-suites across the country, as an NYPD intelligence report obtained by CNN warns online rhetoric could "signal an elevated threat facing executives in the near-term ..." The fingerprint and firearms disclosures come as authorities dig into Mangione, who remains in custody in Pennsylvania on gun-related charges as he fights extradition to New York, where he's charged with murder. Since his arrest Monday thanks to a tipster at a McDonald's, the 26-year-old's background also is starting to come into focus. The privileged scion of a well-to-do family, high school valedictorian and Ivy League graduate vanished from view of his loved ones in recent months, only to emerge as the suspect in a high-profile killing potentially fueled by his struggle with a painful back injury. Mangione's lawyer has denied his client's involvement in the killing in New York and anticipates he will plead not guilty there to the murder charge, among other counts. Mangione also plans to plead not guilty to Pennsylvania charges related to a gun and fake ID police found when they arrested him in Altoona, attorney Thomas Dickey said. "I haven't seen any evidence that they have the right guy," Dickey told CNN's Kaitlan Collins on "The Source." Dickey has not seen the evidence, including writings police said were in Mangione's possession at the time of his arrest, the lawyer reiterated Wednesday on ABC's "Good Morning America." In some of Mangione's writings, he referenced pain from a back injury he got in July 2023, New York Police Chief of Detectives Joseph Kenny told Fox News on Tuesday. Investigators are looking into an insurance claim for the injury. "Some of the writings that he had, he was discussing the difficulty of sustaining that injury," Kenny said. "So, we're looking into whether or not the insurance industry either denied a claim from him or didn't help him out to the fullest extent." Mangione was denied bail at an extradition hearing Tuesday afternoon at the Blair County Courthouse in Pennsylvania. As he entered the courthouse, shackled at the hands and feet and wearing an orange prison jumpsuit with DOC emblazoned on the back, he yelled, in part, "It's completely out of touch and an insult to the intelligence of the American people. It's lived experience." Investigators detail gun, silencer and fake ID New York prosecutors charged Mangione with one count of murder, two counts of second-degree criminal possession of a weapon, one count of second-degree possession of a forged document, and one count of third-degree criminal possession of a weapon, online court documents show. Mangione is the person seen in surveillance video fatally shooting Thompson outside a Hilton hotel en route to his company's annual investor conference, officials assert, citing charging documents in which Detective Yousef Demes of the Midtown North Detective Squad outlines evidence, including that the man seen in surveillance footage from a New York hostel is wearing the same clothing. After arresting Mangione in the Altoona McDonald's, police found "a black 3D-printed pistol and a black silencer" that was also 3D printed, according to the criminal complaint. While being taken into custody, Mangione also presented a forged New Jersey ID with the name Mark Rosario, which matched the ID the man at the hostel used, Demes wrote. Suspect appeared to view targeted killing as a 'symbolic takedown' The suspect appeared to be driven by anger against the health insurance industry and against "corporate greed" as a whole, according to an NYPD intelligence report obtained Tuesday by CNN. "He appeared to view the targeted killing of the company's highest-ranking representative as a symbolic takedown and a direct challenge to its alleged corruption and 'power games,' asserting in his note he is the 'first to face it with such brutal honesty,'" says the NYPD assessment, which was based on Mangione's "manifesto" and social media. Along with a three-page handwritten "claim of responsibility" found on Mangione when he was taken into custody, investigators are looking at the suspect's writing in a spiral notebook, a law enforcement source briefed on the matter told CNN. It included to-do lists to facilitate a killing, as well as notes justifying those plans, the source said. In one notebook passage, Mangione wrote about the late Ted Kaczynski, the so-called Unabomber who justified a deadly bombing campaign as an effort to protect against the onslaught of technology and exploitation. Mangione had written about the Unabomber in online posts as well. Mangione knew UnitedHealthcare was holding an investors' conference around the time Thompson was shot and killed - and the suspect mentioned in writings he would be going to the conference site, the NYPD's Kenny told Fox News on Tuesday. In the notebook passage, Mangione concludes using a bomb against his intended victim "could kill innocents" and shooting would be more targeted, musing what could be better than "to kill the CEO at his own bean counting conference," a law enforcement official briefed on the matter told CNN. The three-page document did not include specific threats but indicated "ill will towards corporate America," Kenny said. Why Mangione may be fighting extradition With Mangione fighting extradition, a Pennsylvania court has given him 14 days to file for writ of habeas corpus - putting the burden of proof on those detaining the person to justify the detention - and a hearing will be scheduled if he does. Pennsylvania prosecutors have 30 days to get a governor's warrant, which New York Gov. Kathy Hochul said she will work with prosecutors to sign and Pennsylvania Gov. Josh Shapiro "is prepared to sign and process ... promptly as soon as it is received." Blair County District Attorney Peter Weeks said his office is prepared "to do what's necessary" to get Mangione back to New York. There could be several reasons Mangione is fighting his extradition, said Karen Agnifilo, a CNN legal analyst and defense attorney. It would give him more time to think about his defense, demand prosecutors present more evidence at his next hearing or try to get bail in Pennsylvania, which is unlikely. Indeed, it could take up to two months before authorities could bring Mangione back to New York after the governor's warrant is obtained, said Agnifilo, who previously worked at the Manhattan District Attorney's Office. Most criminal defendants facing prosecution on more serious charges in another state waive their right to extradition, but in murder cases like Mangione's, "there's no chance he's going to be let out, so he's fighting extradition," she said. "Eight or 9 out of 10 times, defendants waive extradition because they realize this is so perfunctory, it's so easy, and most of them don't want to languish in detention in the other state because you don't even get to fight your case yet," Agnifilo said. Pennsylvania state Judge Dave Consiglio denied Mangione bail related to both state dockets, saying he would remain at the Huntingdon State Correctional Institution. CNN's Steve Almasy, Sara Smart, Gloria Pazmino, Amanda Musa, Celina Tebor, Elizabeth Hartfield, Elise Hammond, Emma Tucker, Jordan Valinsky, Danny Freeman and Kara Scannell contributed to this report. - CNNWhy are so many royals podcasting? And is anyone listening?

Former Tulane quarterback Darian Mensah has already found a new program in Duke, while Mississippi State's Michael Van Buren Jr., Wisconsin's Braedyn Locke and Cal's Fernando Mendoza are exploring changes of their own in the transfer portal. Mensah, a redshirt freshman with three years of eligibility remaining, told ESPN on Wednesday he has transferred to Duke. He attended the Blue Devils men's basketball game against Incarnate Word on Tuesday night. The Blue Devils (9-3) will face Mississippi in the Gator Bowl, but without 2024 starting quarterback Maalik Murphy and backup Grayson Loftis, who also entered the portal. Mensah, viewed as one of the top players in the portal, threw for 2,723 yards and 22 touchdowns and completed 65.9% of his passes. He led the Green Wave to a 9-4 record and the American Athletic Conference championship game, where they lost 35-14 to Army. Tulane will play Florida in the Gasparilla Bowl on Sunday. Van Buren, Mendoza and Locke announced on social media they had entered the portal. Van Buren started eight games as a true freshmen for the Bulldogs. He threw for 1,886 yards on 55% passing with 16 total touchdowns and seven interceptions for the Bulldogs (2-10, 0-8 Southeastern Conference). He took over as the starter when Blake Shapen suffered a season-ending shoulder injury in a 45-28 loss to Florida on Sept. 21. Shapen has said he plans to return next season. Van Buren, a 6-foot-1, 200-pound passer from St. Frances Academy in Maryland, had two 300-yard performances for the Bulldogs, including 306 yards and three touchdown passes in a 41-31 road loss against Georgia. Mendoza threw for 3,004 yards in 2024 with 16 TDs, six interceptions and a 68.7 completion percentage. "For the sake of my football future this is the decision I have reached," he posted. Locke passed for 1,936 yards with 13 touchdowns and 10 interceptions for Wisconsin this season. He said he will have two years of eligibility remaining at his next school. ANN ARBOR, Mich. — Michigan cornerback Will Johnson has joined defensive tackle Mason Graham in the NFL draft. Johnson declared for the draft on Wednesday, one day after Graham decided he would also skip his senior season with the Wolverines. Both preseason All-America players are expected to be first-round picks. Johnson was limited to six games this year due to an injury. He had two interceptions, returning them both for touchdowns to set a school record with three scores off interceptions. Johnson picked off nine passes in three seasons. Graham played in all 12 games this season, finishing with 3 1/2 sacks and seven tackles for losses. He had 18 tackles for losses, including nine sacks, in his three-year career. Tennessee running back Dylan Sampson is The Associated Press offensive player of the year in the Southeastern Conference and South Carolina defensive lineman Kyle Kennard is the top defensive player. Vanderbilt quarterback Diego Pavia was voted the top newcomer on Wednesday while the Gamecocks' Shane Beamer is coach of the year in voting by the panel of 17 media members who cover the league. Sampson led the SEC and set school records by rushing for 1,485 yards and 22 touchdowns. He is tied for third nationally in rushing touchdowns, recording the league's fifth-most in a season. Sampson was chosen on all but two ballots. Mississippi wide receiver Tre Harris and his quarterback, Jaxson Dart, each got a vote. Kennard led the SEC with 11-1/2 sacks and 15-1/2 tackles for loss. He also had 10 quarterback hurries and forced three fumbles. Beamer led the Gamecocks to just their fifth nine-win season, including a school-record four wins over Top 25 opponents. They've won their last six games and ended the regular season with a win over eventual ACC champion Clemson. South Carolina plays Illinois on Dec. 31 in the Citrus Bowl. Pavia helped lead Vandy to its first bowl game since 2018 after transferring from New Mexico State. He passed for 2,133 yards and 17 touchdowns with four interceptions. He ran for another 716 yards and six touchdowns, directing an upset of Alabama. AMES, Iowa — Matt Campbell, who led Iowa State to its first 10-win season and became the program's all-time leader in coaching victories, has agreed to an eight-year contract that would keep him with the Cyclones through 2032. University president Wendy Wintersteen and athletic director Jamie Pollard made the announcement Wednesday, four days after the Cyclones lost to Arizona State in the Big 12 championship game. “Given all the uncertainty currently facing college athletics, it was critical that we moved quickly to solidify the future of our football program,” Pollard said. “Matt is the perfect fit for Iowa State University and I am thrilled he wants to continue to lead our program. Leadership continuity is essential to any organization’s long-term success." The Cyclones won their first seven games for their best start since 1938 and are 10-3 heading into their game against Miami in the Pop Tarts Bowl in Orlando, Florida, on Dec. 28. BRIEFLY FLAG PLANT: Ohio Republican state Rep. Josh Williams said Wednesday on social media he's introducing a bill to make flag planting in sports a felony in the state. His proposal comes after the Nov. 30 fight at the Michigan-Ohio State rivalry football game when the Wolverines beat the Buckeyes 13-10 and then attempted to plant their flag at midfield. MALZAHN: Gus Malzahn, who resigned as UCF’s coach last month to become Mike Norvell’s offensive coordinator at Florida State, said he chose to return to his coaching roots rather than remain a head coach distracted by a myriad of responsibilities. Be the first to know Get local news delivered to your inbox!

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OTTAWA — Billionaire Elon Musk called Canada’s prime minister an “insufferable tool” on his social media platform today. Musk’s comments were in response to Justin Trudeau likening Kamala Harris’s defeat in the U.S. presidential election to an attack on women’s rights and progress. This afternoon, Trudeau met with provincial and territorial premiers to discuss Canada’s approach to negotiations with the U.S. Canada is facing a threat of a 25 per cent tariff hike from incoming president Donald Trump, who defeated Harris in the November election. Earlier this week, Trump taunted Trudeau on social media, referring to the prime minister as the governor of what he called the “Great State of Canada.” The post was an apparent reference to a joke Trump cracked at his dinner with Trudeau at his Mar-a-Lago estate nearly two weeks ago, where the president-elect teased that Canada could join the U.S. as its 51st state. Speaking on Tuesday night at an event hosted by the Equal Voice Foundation — an organization dedicated to improving gender representation in Canadian politics — Trudeau said there are regressive forces fighting against women’s progress. “It shouldn’t be that way. It wasn’t supposed to be that way. We were supposed to be on a steady, if difficult sometimes, march towards progress,” Trudeau said, adding he is a proud feminist and will always be an ally. “And yet, just a few weeks ago, the United States voted for a second time to not elect its first woman president. Everywhere, women’s rights and women’s progress is under attack. Overtly, and subtly.” In a post on X on Wednesday, Musk responded to a clip of Trudeau’s remarks, saying, “He’s such an insufferable tool. Won’t be in power for much longer.” This report by The Canadian Press was first published Dec. 11, 2024. Nick Murray, The Canadian PressDETROIT (AP) — For a second time, a Delaware judge has nullified a pay package that Tesla had awarded its CEO, Elon Musk, that once was valued at $56 billion. On Monday, Chancellor Kathaleen St. Jude McCormick turned aside a request from Musk's lawyers to reverse a ruling she announced in January that had thrown out the compensation plan. The judge ruled then that Musk effectively controlled Tesla's board and had engineered the outsize pay package during sham negotiations . Lawyers for a Tesla shareholder who sued to block the pay package contended that shareholders who had voted for the 10-year plan in 2018 had been given misleading and incomplete information. In their defense, Tesla's board members asserted that the shareholders who ratified the pay plan a second time in June had done so after receiving full disclosures, thereby curing all the problems the judge had cited in her January ruling. As a result, they argued, Musk deserved the pay package for having raised Tesla's market value by billions of dollars. McCormick rejected that argument. In her 103-page opinion, she ruled that under Delaware law, Tesla's lawyers had no grounds to reverse her January ruling “based on evidence they created after trial.” On Monday night, Tesla posted on X, the social media platform owned by Musk, that the company will appeal. The appeal would be filed with the Delaware Supreme Court, the only state appellate court Tesla can pursue. Experts say a ruling would likely come in less than a year. “The ruling, if not overturned, means that judges and plaintiffs' lawyers run Delaware companies rather than their rightful owners — the shareholders,” Tesla argued. Later, on X, Musk unleashed a blistering attack on the judge, asserting that McCormick is “a radical far left activist cosplaying as a judge.” Legal authorities generally suggest that McCormick’s ruling was sound and followed the law. Charles Elson, founding director of the Weinberg Center for Corporate Governance at the University of Delaware, said that in his view, McCormick was right to rule that after Tesla lost its case in the original trial, it created improper new evidence by asking shareholders to ratify the pay package a second time. Had she allowed such a claim, he said, it would cause a major shift in Delaware’s laws against conflicts of interest given the unusually close relationship between Musk and Tesla’s board. “Delaware protects investors — that’s what she did,” said Elson, who has followed the court for more than three decades. “Just because you’re a ‘superstar CEO’ doesn’t put you in a separate category.” Elson said he thinks investors would be reluctant to put money into Delaware companies if there were exceptions to the law for “special people.” Elson said that in his opinion, the court is likely to uphold McCormick's ruling. Experts say no. Rulings on state laws are normally left to state courts. Brian Dunn, program director for the Institute of Compensation Studies at Cornell University, said it's been his experience that Tesla has no choice but to stay in the Delaware courts for this compensation package. The company could try to reconstitute the pay package and seek approval in Texas, where it may expect more friendlier judges. But Dunn, who has spent 40 years as an executive compensation consultant, said it's likely that some other shareholder would challenge the award in Texas because it's excessive compared with other CEOs' pay plans. “If they just want to turn around and deliver him $56 billion, I can't believe somebody wouldn't want to litigate it,” Dunn said. “It's an unconscionable amount of money.” Almost certainly. Tesla stock is trading at 15 times the exercise price of stock options in the current package in Delaware, Morgan Stanley analyst Adam Jonas wrote in a note to investors. Tesla's share price has doubled in the past six months, Jonas wrote. At Monday’s closing stock price, the Musk package is now worth $101.4 billion, according to Equilar, an executive data firm. And Musk has asked for a subsequent pay package that would give him 25% of Tesla's voting shares. Musk has said he is uncomfortable moving further into artificial intelligence with the company if he doesn't have 25% control. He currently holds about 13% of Tesla's outstanding shares.

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