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Jim Rossman | Tribune News Service Cord cutting used to refer to abandoning pay TV and putting up an antenna to watch free over-the-air TV. Then cord cutting expanded to include streaming services like Netflix and Hulu and individual streaming sources. Related Articles San Jose Sharks debut catchy sequel video to ‘Holiday Sweater’ Gift ideas for people planning their next trip Lights and decor, réveillon meals make Christmastime special in New Orleans Why American travelers are choosing Europe for Christmas Jaw-dropping holiday light displays worth the trip this December Now we also include streaming bundles, like YouTube TV or Hulu Live or DirecTV Stream. These bundled services mimic cable and satellite service, in that they have hundreds of channels. The ease or complexity of the cord cutting experience depends on how you have things set up. Let’s take a look at some gift options for your favorite cord cutter. As far as I know DirecTV is the only streaming bundle service that offers its own hardware. The Gemini Air is a small dongle that plugs into an HDMI port on your TV. It is paired with a remote control to allow for easy navigation. If you were an AT&T U-Verse TV customer, the Gemini Air/DirecTV Stream experience will be very familiar. The Gemini Air is a rarity in that it has number buttons. DirecTV Stream has the option of turning on channel numbers in the guide. I’ve used DirecTV Stream with my Roku TV and with the Gemini Air and the Air makes navigating the huge list of channels much easier. The Gemini Air runs the Google operating system, so you can see and use all your other streaming services like Netflix, Hulu, Amazon Prime, Max and more. You can also load apps and games from the Google Play store. The Gemini Air connects to your home’s Wi-Fi network, and it can stream 4K content to your TV. The remote control has a microphone so you can use your voice to search or interact with Hey Google’s voice assistant. DirecTV Stream customers can get a free Gemini Air from AT&T with their service. Additional units are available for $120. There are lots of smart TV brands. Some run on the Roku operating system, some run Google TV and some use their own brand of smart TV apps. If you’d like to add Google TV to any set, you can get Google’s new TV Streamer (4K) for just $99 from store.google.com. The small device connects to your TV’s HDMI port. It also can connect to your home’s internet via Wi-Fi or wired Ethernet connection. The Google TV interface is not tied to any specific streaming service. You can use any streaming service or app that’s available on the Google Play store. It features a simple remote with voice control and the Google TV Streamer is also a hub and controller for Matter and Thread home devices that work with Google’s home ecosystem. If you use an over-the-air antenna for watching your free local channels, I’m betting you’d like the option to record those channels. TiVo used to be the best/easiest way to record OTA TV, but they’ve discontinued their OTA recorders. A great alternative is from TabloTV, which is a small box that you connect to your TV antenna. The TabloTV does not directly connect to your TV. Instead it connects to your home’s Wi-Fi, and the antenna signal is wirelessly sent to any TV or compatible device in your home. Your TV picks up the signal through a free app, which is compatible with smart TV brands like Samsung, LG, Google TV, Roku, Apple TV, Amazon Fire TV or Android TV. This method is extremely handy if you don’t want to be bothered running an antenna wire from your attic or roof all the way to your TV. It’s also great if you want to use an indoor antenna, but your TV is not situated in a room that faces the broadcast towers. You can place the antenna and TabloTV where you get the best reception. The TabloTV comes in two models – with either two or four tuners. This means you can record or watch two or four shows at a time. TabloTV has onboard storage to record up to 50 hours of shows, but you can plug in any USB hard drive and expand to record thousands of hours of programming. You can also bundle a TabloTV with an OTA antenna if you like, or you can use your own antenna. Two things to know, there are no ongoing subscription costs for guide data, and there is no streaming service integration. You will need another way to add in streaming services like Netflix and Hulu. TabloTV models start at $99.95 for the two tuner model at tablotv.com. The four-tuner model is $139.95, but they may be on sale during the holidays. ©2024 Tribune Content Agency, LLC.
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 and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025 Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old Company to host investor webcast today at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study. “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: That the product candidate treats a serious condition That the product candidate generally provides a meaningful advantage over available therapies That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit As DBV previously announced , FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two. 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: FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint. Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety). The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. 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: Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine i n May 2023), and 36 months of open-label extension data. Six months of DBPC data generated in COMFORT Toddlers supplemental safety study. DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026. 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. United States: +1-877-346-6112 International: +1-848-280-6350 A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/ . A replay of the presentation will also be available on DBV’s website after the event. 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 katie.matthews@dbv-technologies.com Media Contact Angela Marcucci DBV Technologies angela.marcucci@dbv-technologies.com Attachment PDF VersionNEW YORK--(BUSINESS WIRE)--Dec 11, 2024-- The Cannabist Company Holdings Inc. (Cboe CA: CBST) (OTCQX: CBSTF) (FSE: 3LP) (“The Cannabist Company” or the “Company”), one of the most experienced cultivators, manufacturers and retailers of cannabis products in the U.S., announced today it is launching the brand dreamt, in Maryland, with additional markets and products to follow in 2025. Earlier this year, the Company acquired the brand through its acquisition of the Ciencia Labs portfolio . The dreamt brand stands out from other cannabis products because of its unique formulations, which include a precise ratio of THC to CBD, in addition to a variety of supplements including GABA, and valerian root. “dreamt is a transformative product, and we couldn’t be more excited to bring these highly sought after products to our shelves. Everyone deserves a good night's sleep to feel refreshed and be at their best,” said Jesse Channon, President, The Cannabist Company. “dreamt products will utilize our high-quality cannabis to make a positive impact in people’s daily lives, as we strive to bring innovation and excellence to our markets.” “dreamt is the result of extensive formulation development. Our goal was to produce these products at our state-of-the-art facilities across multiple markets and provide our patients and customers with a consistent and reliable experience,” said Blake Brower, VP, National Operations, The Cannabist Company. “We’re proud of our ability to maximize our facility's capabilities and supply these high-quality products in the most demanded product category.” dreamt is now available as a 5mg THC, 2mg CBD, 1mg CBN gummy sold in a 20 pack, at Columbia Care Chevy Chase and gLeaf dispensaries in Maryland and across the Company’s wholesale channels. The brand will debut in additional markets and expand its product offering in 2025. For more information, visit cannabistcompany.com or youdreamt.com . About The Cannabist Company (f/k/a Columbia Care) The Cannabist Company, formerly known as Columbia Care, is one of the most experienced cultivators, manufacturers and providers of cannabis products and related services, with licenses in 14 U.S. jurisdictions. The Company operates 91 facilities including 71 dispensaries and 20 cultivation and manufacturing facilities, including those under development and assuming the closure of announced divesture transactions. Columbia Care, now The Cannabist Company, is one of the original multi-state providers of cannabis in the U.S. and now delivers industry-leading products and services to both the medical and adult-use markets. In 2021, the Company launched Cannabist, its retail brand, creating a national dispensary network that leverages proprietary technology platforms. The company offers products spanning flower, edibles, oils and tablets, and manufactures popular brands including Dreamt, Seed & Strain, Triple Seven, Hedy, gLeaf, Classix, Press, and Amber. For more information, please visit www.cannabistcompany.com . Caution Concerning Forward-Looking Statements This press release contains certain statements that constitute “forward-looking information” or “forward-looking statements” within the meaning of applicable securities laws and reflect the Company’s current expectations regarding future events. Forward-looking statements or information contained in this release include, but are not limited to, statements or information with respect to the Company’s ability to execute on retail, wholesale, brand and product initiatives. These forward-looking statements or information, which although considered reasonable by the Company, may prove to be incorrect and are subject to known and unknown risks and uncertainties that may cause actual results, performance or achievements of the Company to be materially different from those expressed or implied by any forward-looking information. In addition, security holders should review the risk factors discussed under “Risk Factors” in Columbia Care’s Form 10-K for the year ended December 31, 2023, as filed with Canadian and U.S. securities regulatory authorities and described from time to time in subsequent documents filed with applicable securities regulatory authorities. View source version on businesswire.com : https://www.businesswire.com/news/home/20241211413838/en/ CONTACT: Investors Lee Ann Evans SVP, Capital Markets investor@cannabistcompany.com Media Mike Moses Communications Manager media@cannabistcompany.com KEYWORD: NEW YORK MARYLAND UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: ALTERNATIVE MEDICINE CANNABIS RETAIL HEALTH SPECIALTY NATURAL RESOURCES SOURCE: The Cannabist Company Holdings Inc. Copyright Business Wire 2024. PUB: 12/11/2024 04:05 PM/DISC: 12/11/2024 04:05 PM http://www.businesswire.com/news/home/20241211413838/en
FORT WORTH, Texas (AP) — Josh Hoover threw for 252 yards and a touchdown and JP Richardson had 149 all-purpose yards and a 38-yard touchdown reception to lead TCU over Arizona 49-28 on Saturday. On the first play from scrimmage, Wildcats quarterback Noah Fifita was intercepted by Bud Clark. TCU scored five plays later on Trent Battle’s 4-yard run. The Horned Frogs scored touchdowns on five straight drives, going at least 75 yards on nine or more plays on three of the possessions. TCU (7-4, 5-3 Big 12) drove 75 yards in 12 plays in the final 1:55 of the first half to take a 21-13 lead on Savion Williams’ 20-yard run. Hoover completed five passes on the drive, including gains of 24, 19, and 24 yards to set up Williams’ score with 20 seconds left in the half. The Horned Frogs took the second-half kickoff and drove 76 yards in nine plays to build a 28-13 lead on Battle’s 1-yard run. Richardson’s 33-yard punt return to the Arizona 34 set up a third touchdown in three possessions. He caught a short pass over the middle from Hoover and raced untouched 38 yards for the score and a 35-13 lead. Richardson led TCU with six catches for 107 yards. Four TCU running backs scored a touchdown, including Williams, who rushed for 80 yards and two scores. Battle also rushed for 28 yards and two scores. Fifita was 29 of 44 for 284 yards with two touchdowns and an interception for Arizona (4-7, 2-6). Tetairoa McMillan made nine catches for 115 yards. Arizona defensive lineman Sterling Lane II picked up a fumble from TCU backup quarterback Ken Seals with just over a minute left in the game and ran it 70 yards for a touchdown to cap the scoring. Clark leads the Horned Frogs with three interceptions, including one in each of the past two games. He is tied for fifth-most in the Big 12. Arizona: The Wildcats, who started the season in the AP Top 25 poll, will not be bowl eligible this season with a game remaining under first-year coach Brent Brennan. A year ago under coach Jedd Fisch, who is now at Washington, Arizona advanced to the Alamo Bowl for the first time since 2017. TCU: The Horned Frogs, who became bowl eligible two weeks ago, won their third consecutive game at Amon Carter Stadium after losing two in a row to UCF and Houston. TCU has won four of its past five, the only blemish a 37-34 last-second loss at Baylor. TCU: At Cincinnati on Saturday. Arizona: Hosts Arizona State on Saturday. Get poll alerts and updates on the AP Top 25 throughout the season. Sign up here. AP college football: https://apnews.com/hub/ap-top-25-college-football-poll and https://apnews.com/hub/college-footballAfter Trump's Project 2025 denials, he is tapping its authors and influencers for key roles