Search This Blog

Wednesday, January 19, 2022

Emirates president: 5G snafu is biggest screwup I've witnessed in my career

 The president of Emirates tells CNN that the airline was not aware of some of the potential 5G rollout issues until yesterday morning, calling the situation "one of the most delinquent, utterly irresponsible" he has seen in his aviation career.

Major international airlines are scrambling to modify or cancel flights to the United States amid uncertainty about potential interference between new 5G cell phone services and critical airplane technologies. Emirates has canceled flights to nine US destinations today.
Speaking to CNN's Richard Quest today, Emirates president Tim Clark said that they were not aware of the issues until yesterday morning "to the extent that it was going to compromise the safety of operation of our aircraft and just about every other 777 operator to and from the United States and within the United States."
    Transportation regulators had already been concerned that the version of 5G that was scheduled to be switched on could interfere with some airplane instruments, and many aviation industry groups shared those fears — despite reassurances from federal telecom regulators and wireless carriers.
    Specifically, the Federal Aviation Administration has been worried that 5G cellular antennas near some airports — not air travelers' mobile devices — could throw off readings from some aircraft equipment designed to tell pilots how far they are from the ground. Those systems, known as radar altimeters, are used throughout a flight and are considered critical equipment. (Radar altimeters differ from standard altimeters, which rely on air pressure readings and do not use radio signals to gauge altitude.)
        In December, the FAA issued an urgent order forbidding pilots from using the potentially affected altimeters around airports where low-visibility conditions would otherwise require them. That new rule could keep planes from getting to some airports in certain circumstances, because pilots would be unable to land using instruments alone.
        "We were aware of a 5G issue. Okay. We are aware that everybody is trying to get 5G rolled out after all it's the super cool future of whatever it may be communication and information flow. We were not aware that the power of the antennas in the United States have been doubled compared to what's going on elsewhere. We were not aware that the antenna themselves have been put into a vertical position rather than a slight slanting position, which then taken together compromise not only the radio altimeter systems but the flight control systems on the fly by wire aircraft. So on that basis we took that decision late last night to suspend all our services until we had clarity," he added, telling Richard Quest the airline wouldn't take any risks.
        When asked on what he makes of the situation, Clark said: "I need to be as candid as I normally am, and say this is one of the most delinquent, utterly irresponsible issue subjects, call it what you like, I've seen in my aviation career because it involves organs of government, manufacturers, science, etc. And you know, the notion that, for instance, the United States government should sell its franchise for all the frequencies for a large amount of money. Somebody should have told them at the time - that the risks and the dangers they placed in certain frequency uses around field, airfields, metropolitan fields that should have been done at the time."
        The Emirates president added that services will be restored if the rollout is suspended and the question of interference of their aircraft systems on approach and landing is removed.
        AT&T, which owns CNN's parent company, and Verizon both announced Tuesday that they would delay activating 5G on some towers around certain airports. The wireless technology's rollout near major airports had been scheduled for Wednesday.
          "We are frustrated by the FAA's inability to do what nearly 40 countries have done, which is to safely deploy 5G technology without disrupting aviation services, and we urge it do so in a timely manner," Megan Ketterer, a spokesperson for AT&T, said.
          The Biden administration welcomed the delay, saying in a statement that the "agreement will avoid potentially devastating disruptions to passenger travel, cargo operations, and our economic recovery, while allowing more than 90% of wireless tower deployment to occur as scheduled."

          Yumanity: Partial Clinical Hold by FDA on Multidose Trials

           Yumanity Therapeutics (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative disease, today announced that, in response to its IND application submitted in December 2021, it was notified via email by the U.S. Food and Drug Administration (FDA) that the FDA has placed a partial clinical hold on multidose clinical trials of YTX-7739, currently being developed for the treatment of Parkinson’s disease. The FDA has not halted all clinical programming and is permitting the Company’s planned single dose clinical trial to proceed. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s questions have been addressed.

          The Company expects to receive additional detail from the FDA within the next 30 days. Yumanity anticipates working closely with the FDA to adequately address their concerns.

          About YTX-7739
          The Company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease and has previously reported results from 14 day and 28 day multiple dosing studies in healthy volunteers and a 28 day multiple dose clinical study in patients with Parkinson’s disease.

          YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models.


          Vivos: 18X Increase in Sleep Apnea Testing By Vivos Dentists Using SleepImage Tech

           Vivos Also Announces Improved Pricing Agreement With SleepImage

          Dentists and Patients Report Exceptional User Experience with SleepImage Home Sleep Test

           Vivos Therapeutics, Inc. (“Vivos” or “the Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring, today announced significant increases across several key metrics for its SleepImage Home Sleep Apnea Tests (HST).

          In particular, for the three-months ended December 31, 2021, versus the three-months ended December 31, 2020, Vivos reported:

          • an 18 times increase in the total number of HSTs given across the network of Vivos trained dentists (known as Vivos Integrated Practices or VIPs);

          • a 5.7 times increase in the number of VIPs administering HSTs; and

          • a 3 times increase in the average number of HSTs being administered per VIP.

          Zogenix Nabs $1.9 Billion Takeover As Epilepsy Drug Piques UCB Interest

           Belgium-based pharmaceutical company UCB will buy Zogenix (ZGNX) for up to $1.9 billion, the companies said Wednesday, leading ZGNX stock to rocket.

          The deal leans into a recent trend of growing pharmaceutical interest in the epilepsy market, Mizuho Securities analyst Vamil Divan said. It follows Jazz Pharmaceuticals' (JAZZ) acquisition of GW Pharma in 2021. Zogenix makes Fintepla, a treatment for a seizure disorder called Dravet syndrome.

          "We have seen increased interest from larger biopharma companies in the rare epilepsy market, but do not expect other potential buyers to step in at this point and expect the deal to close as planned by the end of the second quarter," he said in a report to clients.

          In premarket trading on the stock market today, ZGNX stock soared 67.8% near 26.20.

          ZGNX Stock: Fintepla's Next Approvals

          The announcement comes as Zogenix works to roll out Fintepla in the U.S. and Europe. So far, the drug is approved for Dravet syndrome. But the next potential use is in Lennox-Gastaut syndrome, which is a much bigger market.

          "We would expect an acceleration of Fintepla's growth in Dravet in the U.S. under UCB's lead given UCB's greater ability to invest in the launch," Divan said.

          Under the terms of the deal, UCB will pay $26 per share for ZGNX stock. The deal also includes an added cash payment of $2 per share — known as a contingent value right — if Fintepla wins European approval in Lennox-Gastaut syndrome by Dec. 31, 2023.

          Before that, the Food and Drug Administration will consider approving Fintepla for Lennox-Gastaut no later than March 25.

          "We assume investors will likely wait for a positive FDA decision in March before becoming overly optimistic on the likelihood of the CVR playing out," Divan said.

          https://www.investors.com/news/technology/zgnx-stock-rockets-on-ucb-takeover/

          UnitedHealth Earnings Top Views

          UnitedHealth Group (UNH) kicked off Q4 reporting for the managed-care sector before Wednesday's open, topping estimates and standing by 2022 guidance. After the report, UNH stock rose slightly in Wednesday's stock market action.

          "Our strong 2021 performance and confident growth outlook for 2022 and beyond reflect the accelerating innovation and expanding capabilities across Optum and UnitedHealthcare," CEO Andrew Witty said in a statement.

          UNH Earnings

          Estimates: Analysts expected UnitedHealth earnings of $4.31 per share, up 71% from a Covid-hit year-ago result. Revenue was seen growing 11.7% to $73.1 billion.

          Results: UnitedHealth earnings per share grew 78% to $4.48. Revenue rose 12.6% to $73.7 billion.

          Medical costs as a share of premiums came in at 83.7% in Q4.

          Outlook: UnitedHealth stood by initial full-year 2022 guidance that was issued ahead of its Nov. 30 investor day for adjusted EPS of $21.10 to $21.60. Analysts expect UnitedHealth to earn $21.71 per share. The company noted that it also was sticking by guidance for Medicare Advantage membership, indicating that enrollment for 2022 was on track.

          UNH Stock

          UNH stock rose 0.8% to 464.80 in morning trade. UNH stock closed off 1.6% to 460.99 in Tuesday's market drubbing, slipping back below its 50-day moving average.

          UNH stock finished Tuesday's session 9.5% below its 509.23 record high set on Dec. 30. The managed-care sector got the year off to a rocky start, as the whole group got caught in Humana's (HUM) downdraft after the insurer warned on Medicare Advantage enrollment on Jan. 6.

          If UNH can retake its 21-day line as well as its 50-day average, that could provide an entry point. A break above the 50-day average for quality stocks can provide an early entry point, especially when the test of its 50-day comes above the prior buy point. That's the case for UNH stock, which rose clear of 431.46 buy point on Oct. 20.

          https://www.investors.com/news/unitedhealth-earnings-top-views-unh-stock-near-key-level/

          Adma: Prelim Revenue and Business Update

           Fourth Quarter 2021 Preliminary Unaudited Total Revenues of Approximately $26 Million, the Highest Quarterly Revenue for the Company Since Inception

          Full Year 2021 Preliminary Unaudited Total Revenues of Approximately $81 Million, a 92% Increase Over Full Year 2020

          Company Reiterates All Previously Provided Financial Targets

          Ongoing Strategic Review & Debt Refinancing Activities

          https://finance.yahoo.com/news/adma-biologics-announces-record-preliminary-120000914.html

          Cardiff Oncology New Data from Lead Colorectal Cancer Program

           12 of 35 (34%) patients treated per protocol at the recommended Phase 2 dose (RP2D) in combination with FOLFIRI and bevacizumab achieved a complete response or partial response (CR: 1 patient; PR: 11 patients)

          - 17 of 48 (35%) patients across all dose levels achieved a CR or PR. Historically, objective response rates (ORR) of 5-13% have been reported in similar second line patient populations treated with various different drug combinations, including the standard of care chemotherapy of FOLFIRI with bevacizumab1-4

          - 5 of 48 (10%) patients discontinued the trial to pursue potentially curative metastasis-directed therapy (surgical resection or microwave ablation)

          - Median progression-free survival (mPFS) across all response-evaluable patients (n=48) is 9.4 months and has not yet been reached in those treated per protocol at the RP2D. Historically, mPFS of ~4.5-5.7 months has been reported in a similar patient population treated with standard of care chemotherapy of FOLFIRI with bevacizumab1-4

          - The combination regimen of onvansertib plus FOLFIRI/bevacizumab is well tolerated with no major or unexpected toxicities attributed to onvansertib

          - Company management is hosting a webcast and conference call today at 5:00 PM ET

          Webcast and Conference Call

          The newly announced data are being discussed today at 5:00 PM ET as part of a webcast and conference call with members of the Cardiff Oncology management team. To access the webcast, click here. To participate by phone, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13725845. Following the live event, an archived webcast will be available on the "Events" section of the Cardiff Oncology website.

          https://finance.yahoo.com/news/cardiff-oncology-announces-data-lead-220000901.html