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LOS ANGELES, Sept. 30, 2021 /PRNewswire/ -- The Schall Law Firm , a national shareholder rights litigation firm, reminds investors of a class action lawsuit against PolarityTE, Inc. ("PolarityTE" or "the Company") (PTE) - Get PolarityTE, Inc. Report for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission.

Investors who purchased the Company's securities between April 30, 2020 and August 23, 2021, inclusive (the ''Class Period''), are encouraged to contact the firm before November 23, 2021.

If you are a shareholder who suffered a loss, click here to participate.

We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at www.schallfirm.com , or by email at brian@schallfirm.com .

The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member.

According to the Complaint, the Company made false and misleading statements to the market. PolarityTE's Investigational New Drug Application for SkinTE failed to provide sufficient information on Chemistry, Manufacturing, and Control (CMC) items. Based on this deficiency, the FDA was unlikely to approve SkinTE based on the New Drug Application. The Company materially overstated the likelihood of SkinTE achieving regulatory approval. Based on these facts, the Company's public statements throughout the class period were false and materially misleading. When the market learned the truth about PolarityTE, investors suffered damages.

Join the case to recover your losses.

The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.

CONTACT:

The Schall Law Firm Brian Schall, Esq., www.schallfirm.com Office: 310-301-3335 info@schallfirm.com

View original content to download multimedia: https://www.prnewswire.com/news-releases/shareholder-action-notice-the-schall-law-firm-reminds-investors-of-a-class-action-lawsuit-against-polarityte-inc-and-encourages-investors-with-losses-in-excess-of-100-000-to-contact-the-firm-301388993.html

SOURCE The Schall Law Firm

Enacademic

Posted: 30 Sep 2021 09:01 AM PDT

https://t.me/enacademicgroup/6613543

Posted: 30 Sep 2021 08:31 AM PDT

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Ils ont une GROSSE diarrhée au lycée... - American Vandal Saison 2 Bande Annonce

Posted: 30 Sep 2021 09:18 AM PDT

"Ils ont une GROSSE diarrhée au lycée..." - American Vandal Saison 2 Bande Annonce https://www.youtube.com/watch?v=kyVRaAV1hLo

https://t.me/enacademicgroup/6613544

Posted: 30 Sep 2021 08:30 AM PDT

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H.B. Fuller Announces Quarterly Dividend

Posted: 30 Sep 2021 09:30 AM PDT

H.B. Fuller Company (FUL) - Get H.B. Fuller Company Report announced today that its Board of Directors declared a regular quarterly cash dividend of $0.1675 per share of common stock. The dividend is payable on Oct. 28, 2021 to shareholders of record at the close of business on Oct. 14, 2021. H.B. Fuller has paid cash dividends on its common stock for 53 consecutive years.

About H.B. Fuller Company:

Since 1887, H.B. Fuller has been a leading global adhesives provider focusing on perfecting adhesives, sealants and other specialty chemical products to improve products and lives. With fiscal 2020 net revenue of $2.8 billion, H.B. Fuller's commitment to innovation brings together people, products and processes that answer and solve some of the world's biggest challenges. Our reliable, responsive service creates lasting, rewarding connections with customers in electronics, disposable hygiene, medical, transportation, aerospace, clean energy, packaging, construction, woodworking, general industries and other consumer businesses. And, our promise to our people connects them with opportunities to innovate and thrive. For more information, visit us at https://www.hbfuller.com/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210930005815/en/

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Posted: 30 Sep 2021 08:33 AM PDT

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Posted: 30 Sep 2021 08:33 AM PDT

NCAA Division 1 Football Added To ReelTime Media Sports Network Providing Placement Coverage In Televised Games And At All Stadiums During Games

Posted: 30 Sep 2021 09:01 AM PDT

https://t.me/enacademicgroup/6613552

Posted: 30 Sep 2021 08:30 AM PDT

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Differences between Windows 11 Home, Pro, Enterprise, and Education

Posted: 30 Sep 2021 09:23 AM PDT

Windows 11 is set to begin rolling out on October 5, 2021, bringing new features including an updated taskbar and start menu, new multitasking features, and support for widgets.

For the most part users will have a choice between two versions of the operating system: Windows 11 Home or Windows 11 Pro. But Microsoft will also offer a few specialized versions including Windows 11 Enterprise and Windows 11 Education. So what are the differences?

Home users are most likely to encounter the Home or Pro versions of Windows 11, while users who get their computers through work or school may use the Enterprise or Education versions. And for the most part they'll look and feel the same, with the same user interface and features.

But Windows 11 Pro, Enterprise, and Education include features that let system administrators set group policies, have firmer control over how and when OS updates or app updates are delivered, and other features that come in handy when you're trying to manage data and security for multiple users.

Here's a comparison of Windows 11 Home, Pro, Enterprise and Education editions:

Feature	Windows 11 Home	Windows 11 Pro	Windows 11 Enterprise	Windows 11 Education
Bitlocker Device Encryption		✓	✓	✓
S Mode option	✓
Device Encryption	✓	✓	✓	✓
Find My Device	✓	✓	✓	✓
Firewall and Network Protection	✓	✓	✓	✓
Internet Protection	✓	✓	✓	✓
Parental Controls and Protection	✓	✓	✓	✓
Secure Boot	✓	✓	✓	✓
Windows Hello	✓	✓	✓	✓
Windows Information Protection (WIP)		✓	✓	✓
Windows Security	✓	✓	✓	✓
Assigned Access		✓	✓	✓
Dynamic Provisioning		✓	✓	✓
Enterprise State Roaming with Azure		✓	✓	✓
Group Policy		✓	✓	✓
Kiosk Mode Setup		✓	✓	✓
Microsoft Store for Business		✓	✓	✓
Mobile Device Management		✓	✓	✓
Support for Active Directory		✓	✓	✓
Support for Azure Active Directory		✓	✓	✓
Windows Update for Business		✓	✓	✓

For home users, one of the biggest differences between Windows 11 Home and Pro are likely that the Pro version comes with support for Bitlocker Device Encryption, which allows for full-disk encryption for internal hard drives or SSDs as well as portable drives. Windows 11 actually adds support for Bitlocker Device Encryption on more hardware than older versions of Windows, including PCs that originally shipped with Windows 10 Home. But you'll still need Windows 11 Pro (or Enterprise or Education) to use it.

Another difference is that this time around only Windows 10 Home Edition will be available in "S Mode," which is a version of Windows designed for computers with limited resources. For performance and security reasons, it prevents users from installing apps from sources other than the Microsoft Store and restricts users to using Microsoft Edge for the web browser. Customers who purchase a laptop with Windows 11 Home Edition in S Mode will be able to switch to Windows 11 Home for free, but the move is one-way: there's no option to revert to S Mode after you've switched to the full version of Windows.

Microsoft will also likely offer a few variations of these operating systems including Windows 11 IoT Enterprise, Windows 11 Pro for Workstations, and Windows

via Microsoft (1)(2)

The post Differences between Windows 11 Home, Pro, Enterprise, and Education appeared first on Liliputing.

academic2

Posted: 30 Sep 2021 06:57 AM PDT

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IIROC Trading Halt - DHT.UN

Posted: 30 Sep 2021 09:01 AM PDT

CatholicVote Education Fund Launches New Educational Initiative: EDIFY

Posted: 30 Sep 2021 09:10 AM PDT

CHICAGO, Sept. 30, 2021 /PRNewswire/ -- The CatholicVote Education Fund today launched its newest educational initiative, called EDIFY, featuring top experts from around the country to help Catholics and all people tackle the most complex hot-button issues of the day.

EDIFY is an entirely new educational platform created to address controversial issues through the lens of Catholic Social Teaching. EDIFY will share the truths of the Catholic faith and the foundational values of America through regular weekly five-minute animated videos, podcasts, and more. With an initial investment of $3 million, the new initiative is a continuation of CatholicVote's mission to inspire every Catholic in America to live the truths of our faith in public life.

Earlier this year, CatholicVote's President, Brian Burch, hired Scot Landry, a Catholic executive with leadership experience in several Catholic organizations, to direct EDIFY. "Brian invited me to imagine a PragerU for Catholics," Landry said. "EDIFY will equip every parent, grandparent, priest and concerned peer with easily shareable videos and more that address the most hot-button topics of the day."

Landry added: "Today in America there are many harmful ideas being pushed in our culture and onto our young people, such as critical race theory, gender ideology, socialism, aggressive secularism, and other destructive ideologies. American Catholics want resources to win the war of ideas and elevate the conversations that shape our families, workplaces, parishes, and communities."

"Politics can be an ideal doorway into the richness and breadth of the wisdom of the Church," Landry continued. "EDIFY is designed to help all Americans, and especially Catholics, to think with the Church and help make sense of our world."

EDIFY means "to teach in ways that enlighten, encourage and uplift individuals intellectually, morally, or spiritually." Landry noted: "EDIFY is a perfect name to describe what we are hoping to accomplish for our church and our country."

Today, EDIFY is debuting its first two five-minute videos . As a major educational platform for CatholicVote, EDIFY will grow over time to include additional features, including school civics programs, interactive interviews with thought leaders, and much more.

Burch commented: "We could not be more excited to announce the launch of EDIFY. Anyone engaged in American public life knows Catholics are often confused by what the Church teaches, or how to apply the wisdom of the Church to various issues. We wanted to create something bigger than a single election cycle, and address the challenge of being authentically Catholic in the messy world of politics. EDIFY is the answer."

Registration for EDIFY is free at EDIFY.us . For more information/ on EDIFY, please read its e-brochure .

EDIFY is an initiative of the CatholicVote Education Fund, a 501(c)3 organization dedicated to inspiring every Catholic in America to live out their faith in public life. CatholicVote and the CatholicVote Education Fund include over 400,000 members.

View original content: https://www.prnewswire.com/news-releases/catholicvote-education-fund-launches-new-educational-initiative-edify-301389086.html

SOURCE CatholicVote

BizVibe Highlights Key Challenges Facing The Nonferrous Metal Production And Processing Industry | Monitor Business Risk And View Company Insights

Posted: 30 Sep 2021 08:33 AM PDT

https://t.me/enacademicgroup/6613519

Posted: 30 Sep 2021 08:01 AM PDT

Русский: IBM Academic Initiative - Инструмент управления доступом (A2MT)

IBM Academic Initiative - Инструмент управления доступом (A2MT)
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Francis Lai — Concerto Pour La Fin D'un Amour (1969)

Posted: 30 Sep 2021 09:44 AM PDT

https://youtu.be/rUUo7RTnaBk

Un miracle de nostalgie comme seul Claude Lelouch est capable de le filmer, servi par la musique géniale de Francis Lai et une Annie Girardot au summum de son art. Le cinéma sans Claude Lelouch, cela n'est pas le cinéma.

Написал asergj на french_song.d3.ru / комментировать

Извините за, наверное глупый вопрос. А почему я плачу налог каждый год за машину?

Posted: 30 Sep 2021 09:38 AM PDT

Извините за, наверное глупый вопрос. А почему я плачу налог каждый год за машину?

Написал BigBoy на economics.d3.ru / комментировать

Bluepoint всё-таки присоединилась к Sony — следующая игра студии будет оригинальной

Posted: 30 Sep 2021 09:10 AM PDT

Вслед за июньской утечкой президент PlayStation Studios Хермен Хюльст (Hermen Hulst) на сайте официального блога PlayStation подтвердил присоединение к внутренним студиям Sony Interactive Entertainment коллектива Bluepoint Games. Источник изображений: Sony Interactive Entertainment

academic2.ru

Posted: 30 Sep 2021 09:01 AM PDT

trajk

Posted: 30 Sep 2021 09:29 AM PDT

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Posted: 30 Sep 2021 09:01 AM PDT

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Posted: 30 Sep 2021 08:01 AM PDT

Article: العربية: برقية القطعة (Клуб поклонников Фёдора Бондарчука)

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Republicans won't raise the debt ceiling because it will "hike the deficit"

Posted: 30 Sep 2021 07:21 AM PDT

submitted by /u/MoniMokshith to r/PoliticalHumor
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untitled العربية: برقية القطعة External link: t

Posted: 30 Sep 2021 09:29 AM PDT

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العربية: برقية القطعة
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Enacademic

Posted: 30 Sep 2021 09:01 AM PDT

Marine Stewardship Council Encourages Americans To Come Together For A Big Blue Future This National Seafood Month

Posted: 30 Sep 2021 08:33 AM PDT

Light Joins Partners For Automated Vehicle Education (PAVE)

Posted: 30 Sep 2021 09:14 AM PDT

SILICON VALLEY, Calif., Sept. 30, 2021 /PRNewswire/ -- Light , a leading provider of depth perception for vehicles,, announced today that it joined the Partners for Automated Vehicle Education (PAVE) coalition, a coalition of business, nonprofits and academics that share the common goal of informing the public about automated vehicles to help shape the future of transportation. In joining PAVE, Light further commits to not only the development of more advanced and safer vehicles for the future, but also the education of consumers about those systems for public trust.

"The future of transportation will be driven by technological advancements that will require an informed public to fully understand and trust these advanced driver systems," said Dave Grannan, CEO, Light. "We share PAVE's ideas of sensible regulation and safe, responsible testing of advanced vehicles and autonomous driving systems. We look forward to collaborating with them on our shared goal."

Light's Clarity platform uses cameras, working in tandem, to enable vehicles to see 3D structures in the road from 10 centimeters up to 1000 meters away. Allowing advanced driver assistance and autonomous driving systems the ability to see farther and better, Clarity outperforms the range of best-in-class lidar. Clarity provides far greater detail by seamlessly combining image detail with measured depth across the camera's field-of-view. The result is safer and more capable automatic braking, adaptive cruise control, and lane-keeping systems on vehicles by 2023, and entirely new capabilities in the vehicles of the future.

"We are delighted to have Light join PAVE in our mission to raise the level of public understanding about automated vehicles and the potential they offer," said PAVE Executive Director Tara Andringa. "Light's expertise in vehicle depth perception will augment PAVE's educational mission to help demystify AV technology. We are thrilled to work with the Light team to share with the public the transformative potential of AV technologies to improve the safety of our roadways."

About Light

Light is pioneering real-time 3D perception to redefine how vehicles see the world. By combining the company's breakthroughs in computational imaging with multi-camera calibration and advanced machine learning, Light's technology provides accurate depth at both near and far distances in real-time. Founded in 2013, Light is headquartered in Redwood City, CA. See more at https://light.co

About PAVE

Partners for Automated Vehicle Education is a coalition of industry, nonprofit and academic institutions with one goal: To inform and educate the public and policymakers on the facts regarding automated vehicles so that they can fully participate in shaping the future of our roads and highways. PAVE's members, led by co-chairs Audi of America and the National Safety Council, believe that the public needs factual information about AV technology in order to fully realize the potential benefits the technology can offer to increased safety, mobility and sustainability. Launched in January 2019, PAVE's activities include hands-on public demonstration events, policymaker workshops, developing educational materials for dealer and customer-service personnel and active online and social media channels. For more on PAVE: Visit pavecampaign.org, Facebook: @PAVEcampaign; Twitter: @PAVEcampaign, and Instagram: account @PAVEcampaign.

View original content: https://www.prnewswire.com/news-releases/light-joins-partners-for-automated-vehicle-education-pave-301389090.html

SOURCE Light

As Businesses Struggle To Attract Workers, ADP Research Institute Study Pinpoints Human Resources' Impact On A Company's Talent Brand With New Metric To Measure HR Performance

Posted: 30 Sep 2021 09:15 AM PDT

ROSELAND, N.J., Sept. 30, 2021 /PRNewswire/ -- In a first-of-its-kind study, ADP Research Institute (ADPRI) uncovered the HR XPerience Score (HRXPS) metric to measure HR service quality and the impact of the human resources (HR) function, as well as identified the key factors that directly correlate to a strong talent brand as seen through the lens of the employee's experience. This 25-country study of more than 32,000 respondents offers studied intel on the importance of HR to the talent brand based on key interactions during an employee's talent journey, providing new insights for the HR and business community as the workforce refocuses efforts on engaging, hiring and retaining talent.

To better understand what influences a company's talent brand - the likelihood an employee would recommend their company to a family member or friend as a place to work - the study set out to pinpoint the factors that influence the talent brand and generate a high HRXPS. It also identified what exactly will influence an employee's intent to leave, and influence people to actually leave.

Generating a strong HRXPS is influenced by an employee's relationship with HR and frequency of interaction. Employees who have a single point of contact with HR are twice as likely to say HR is Value-Promoting than those with multiple HR contacts, and 5 times more likely than employees who have no HR. Additionally, the number of interactions matter as employees are 7.4 times more likely to say HR is Value-Promoting when they experience at least seven interactionswith HR compared to no interactions. In fact, the study found the more services that are used by an employee, the higher the HRXPS, and those who use five services from HR are 11 times more likely to say HR is Value-Promoting than those who don't use any services. The research indicates that onboarding, performance attention and health benefits are the specific HR services that influence a higher HRXPS.

"While companies have always tried to better understand what contributes to the talent brand, we now have a studied metric to effectively measure the HR function," said Marcus Buckingham, head of people and performance research at the ADP Research Institute. "Our research found that the HR function is critical to the talent brand - so much that every employee interaction that takes place, specific services used and a personalized feel with a single point of contact are what influences a higher HRXPS. In fact, this high-ranking, single point of contact upends the current industry trend of doing away with HR."

"The workforce remains hyper-focused on the need for talent, as job vacancies soar and competition for top talent remains high," said Sreeni Kutam, chief human resources officer, ADP. "At the center of driving talent, both in acquisition and retention, as well as the talent brand, sits HR. Its importance can now be measured with an industry benchmark to gauge the strength of an organization's HR function. As companies continue to ramp up hiring, HR has an opportunity to refocus efforts on the onboarding process as this is a critical touchpoint, as uncovered in the study. A company's talent is vital and this study shows where and how HR can make a direct impact on the talent brand of an organization."

Real-world actions and behaviors that support HRXPS :

What influences HRXPS: As part of the study, ADPRI created a metric to measure and categorize the HR function of a company as Value-Promoting, Value-Performing and Value-Detracting, which can be used as an industry benchmark of comparison to the national and global level of a company's HR function.

A positive perspective of HR:

When an employee thinks HR is Value-Promoting, they are 8 times more likely to be a talent brand promoter.

Likelihood of intent to leave:

Employees who are Value-Promoting are 3.7 times more likely to have no intent to leave compared to Value-Detracting.
However, for employees who are Value-Detracting according to HRXPS, they are 3.4 times more likely to be actively searching for a new job compared to Value-Promoting.

Timeline to actual voluntary terminations:

Employees who voluntarily leave are 1.6 times more likely to see HR as Value-Detracting three months prior to leaving the company.

Key factors that influence HRXPS: The global study found that overall, HR interactions and the human experience have a dramatic effect on a company's talent brand and can influence retention.

A single point of contact:

Employees who have a single point of contact with HR are twice as likely to say HR is Value-Promoting than employees with multiple HR contacts, and 5 times more likely than employees who have no HR at all.

Frequency of HR Interaction:

Employees who had seven interactions with HR are 7.4 times more likely to say HR is Value-Promoting than those who have had no interactions.
The more services used by an employee, the higher the HRXPS; an employee who uses five HR services is 11 times more likely to say HR is Value-Promoting than an employee who doesn't use any services.

Top HR services that influence HRXPS:

Onboarding:

Employees that experience a formal onboarding process are 8.5 times more likely to say HR is Value-Promoting compared to those who had no formal onboarding.

Performance Attention:

Employees who receive the most frequent attention on their performance are 4.4 times more likely to say HR is Value-Promoting than those who receive no performance attention.

Health Benefits

Employees who receive health benefits and use them are 3.5 times more likely to say HR is Value-Promoting than those not offered health benefits.

Employee characteristics that do not relate to HRXPS :

The study further analyzed additional factors and characteristics that do not relate to HR's service quality. Employment status, whether full time or part time, does not increase the likelihood of any one of the HRXPS categories. The average HRXPS is relatively equal between full time and part time workers. Being a certain gender or agedoes not increase one's likelihood to view HR as Value-Promoting or Value-Detracting, nor does an employee's level of education. High school graduates are just as likely to rate HR as Value-Promoting as a college graduate. While an employee's tenure with an organization has been found to be a driver for many outcomes, such as Engagement, length of employment does not increase the likelihood of being in any one of the HRXPS categories. Company size has also been found to not impact the HRXPS.

For a more detailed look and to download ADP Research Institute's HRXPS, visit ADPRI.org.

About the ADP Research Institute The mission of the ADP Research Institute is to generate data-driven discoveries about the world of work, and to derive reliable economic indicators from these insights. We offer these findings to the world at large as our unique contribution to making the world of work better and more productive, and to bring greater awareness to the economy at large.

About ADP (ADP) - Get Automatic Data Processing, Inc. ReportDesigning better ways to work through cutting-edge products, premium services and exceptional experiences that enable people to reach their full potential. HR, Talent, Time Management, Benefits and Payroll. Informed by data and designed for people. Learn more at ADP.com.

ADP, the ADP logo, Always Designing for People and ADP Research Institute are trademarks of ADP, Inc.

View original content to download multimedia: https://www.prnewswire.com/news-releases/as-businesses-struggle-to-attract-workers-adp-research-institute-study-pinpoints-human-resources-impact-on-a-companys-talent-brand-with-new-metric-to-measure-hr-performance-301388899.html

SOURCE ADP, Inc.

https://t.me/enacademicgroup/6613532

Posted: 30 Sep 2021 08:01 AM PDT

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IIROC Sanctions Alfred Drose

Posted: 30 Sep 2021 09:11 AM PDT

TORONTO, Sept. 30, 2021 /CNW/ - A Hearing Panel of the Investment Industry Regulatory Organization of Canada (IIROC) imposed the following penalty on Alfred Drose:

(a) a fine of $137,171, which includes disgorgement of $112,171;

(b) a 24-month prohibition on approval of registration with IIROC in any capacity;

(d) a 12-month period of strict supervision upon any approval with IIROC.

Mr. Drose is also required to pay costs in the amount of $35,000.

The penalty decision dated September 17, 2021 can be found at:

Re Drose, 2021 IIROC 17

In an earlier decision dated July 6, 2021, the Hearing Panel found that Mr. Drose was liable for failing to know his client and excessive trading that was outside the bounds of good business practice.

The decision on Liability can be found at:

Re Drose, 2021 IIROC 14

IIROC formally initiated the investigation into Mr. Drose's conduct in December 2019. The violations occurred while he was a Registered Representative with the Toronto branch of Chippingham Financial Group, formerly an IIROC-regulated firm. Mr. Drose is no longer a registrant with an IIROC-regulated firm.

All information about disciplinary proceedings relating to current and former member firms is available in the Enforcement section of the IIROC website.

Background information regarding the qualifications and disciplinary history, if any, of advisors currently employed by IIROC-regulated firms is available free of charge through the IIROC AdvisorReport service. Information on how to make investment dealer, advisor or marketplace-related complaints is available by calling 1 877 442-4322.

IIROC investigates possible misconduct by its member firms and/or individual registrants. It can bring disciplinary proceedings which may result in penalties including fines, suspensions, permanent bars, expulsion from membership, or termination of rights and privileges for individuals and firms.

IIROC is the pan-Canadian self-regulatory organization that oversees all investment dealers and their trading activity in Canada's debt and equity markets. IIROC sets high quality regulatory and investment industry standards, protects investors and strengthens market integrity while supporting healthy Canadian capital markets. IIROC carries out its regulatory responsibilities through setting and enforcing rules regarding the proficiency, business and financial conduct of 174 Canadian investment dealer firms of varying sizes and business models, and their more than 31,000 registered employees. IIROC also sets and enforces market integrity rules regarding trading activity on Canadian debt and equity marketplaces. For more information,visit www.iiroc.ca.

SOURCE Investment Industry Regulatory Organization of Canada (IIROC) - General News

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Posted: 30 Sep 2021 09:01 AM PDT

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Catalyst Pharmaceuticals Receives Positive Decision From Appeals Court That Supports Orphan Drug Exclusivity For Firdapse® For LEMS

Posted: 30 Sep 2021 09:08 AM PDT

CORAL GABLES, Fla., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that it has received a positive decision from the 11 th Circuit Court of Appeals in its appeal to overturn a District Court decision upholding the U.S. Food and Drug Administration's (FDA) approval of another amifampridine product, Ruzurgi ®, for pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) despite existing Orphan Drug exclusivity for Catalyst's Firdapse ® (amifampridine) Tablets 10 mg.

With this ruling, the 11 th Circuit Court panel has reversed the District Court's decision and remanded the matter to the District Court with instructions to enter summary judgment for Catalyst. The Court's decision adopted Catalyst's core argument that the FDA's approval of Ruzurgi ® violated Catalyst's rights to Orphan Drug Exclusivity.

"We are extremely pleased with the 11 th Circuit Court's decision and are hopeful that it brings to a close this case that is not just important for Catalyst, but for all patients living with rare diseases who depend on medicines that would not be available if not for the efforts and investment of pharmaceutical companies willing to pursue these indications," said Patrick J. McEnany, Catalyst's Chairman and CEO. "The purpose of the Orphan Drug Act is to encourage pharmaceutical companies to make the R&D investments necessary to bring FDA-approved therapies to patient populations living with very rare diseases, and the biggest incentive the Orphan Drug Act provides is the ability to have an exclusive market within that rare disease for their drug for seven years once they obtain approval. The Orphan Drug Act has proven successful for the more than 350 rare diseases that now have an FDA-approved treatment, but there still remains about 6,500 rare diseases that do not have an approved therapy - and the incentives to develop drugs to treat these rare diseases need to remain intact. This decision increases the hope for the patients living with these diseases that one day soon an approved drug for their rare disease might be a reality. This is a goal that we feel we share with the FDA despite this dispute, and we look forward to working with the FDA in the future on these issues."

Mr. McEnany continued: "Now that the Circuit Court has ruled, we are aware that this will create questions and concerns among patients currently on Ruzurgi ® as well as the physicians treating them. Our priority has always been, and will continue to be, to treat patients needs first, and so we are prepared to address their questions and do everything we can to ensure that ALL patients will have uninterrupted access to amifampridine for treating their LEMS condition. Our patient-focused Catalyst Pathways ® team stands ready to provide information to patients currently being treated with Ruzurgi ® on how best to transition to Firdapse ®. Please find below information on how to reach a Catalyst Pathways ® team member to assist you with this transition."

Transitioning to Firdapse ® - Information for Prescribers and Patients Available at 1-833-422-8259 and www.yourcatalystpathways.com

Catalyst Pathways ®, as Catalyst's patient services program, is only open for adults LEMS patients to enroll, but its staff is available to answer questions from the parents of pediatric LEMS patients and the physicians treating them on available access for pediatric LEMS patients to obtain Firdapse ®. These include:

Catalyst's Expanded Access Program which can provide investigational product to pediatric LEMS patients.
Catalyst will provide support if a prescriber wishes to file an investigator initiated Investigational New Drug Application (IND) with the FDA, including Catalyst providing investigational product once the physician's IND is active.
In addition, Catalyst will approach FDA to discuss expanding the Firdapse ® approval to include pediatric LEMS, though any effort to do so will take time and is not guaranteed.

For the larger number of adult LEMS patients who have been receiving Ruzurgi ® off-label, prescribers should call 1-833-422-8259 in order to obtain information on transitioning those patients to Firdapse ® and the steps to enroll them in Catalyst Pathways ®.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for other rare diseases. Catalyst's New Drug Application for Firdapse ® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse ® is commercially available in the United States as a treatment for adults with LEMS. Further, in July 2020 Canada's national healthcare regulatory agency, Health Canada, approved the use of Firdapse ® for the treatment of adult patients in Canada with LEMS.

Firdapse ® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the extent to which this decision will affect the use of Firdapse ® by LEMS patients, (ii) whether the FDA and/or Jacobus exercises their opportunities to appeal this decision, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2020 and Catalyst's other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Media ContactDavid SchullRusso Partners(212) 845-4271david.schull@russopartnersllc.comCompany ContactPatrick J. McEnanyCatalyst PharmaceuticalsChief Executive Officer(305) 420-3200pmcenany@catalystpharma.com

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Posted: 30 Sep 2021 09:01 AM PDT

The Best Live TV Streaming Alternatives To YouTube TV

Posted: 30 Sep 2021 09:30 AM PDT

With YouTube TV potentially losing 13 NBCUniversal channels, and five of its regional sports networks on September 30, 2021, it might be a good time to check out the competition and potentially switch. That's the beauty of cord-cutting though. You can switch providers at any time. Unlike with Cable, where you can really only switch to one other company, as there's generally only two cable options in every city and town.

We have rounded up the best Live TV Streaming alternatives for YouTube TV. These all have NBC's channels, though some may require an additional package to get them – Sling TV for example won't have NBC, but will have its other channels available.

So let's go through the best alternatives and see if it is worth it to switch from YouTube TV. It's worth mentioning that YouTube TV is still one of the only services offering unlimited cloud DVR, and for free. DIRECTV Stream has it, for an additional $10 per month. While others don't offer it at all.

	Cost	Sign Up
DIRECTV Stream	$69/month	Sign Up
FuboTV	$65/month	7-Day Free Trial
Hulu + Live TV	$65/month	7-Day Free Trial
Sling TV	$35/month	$10 for the first month

DIRECTV Stream

Price: Starting at $69/month
Free trial available: No
Sign Up

DIRECTV Stream is the third iteration of AT&T's streaming Live TV service, and it offers a lot of channels that many of its competitors do not. Hence why it is priced higher than the others on this list.

Starting at $69/month, you can get 65+ channels. But if you really want or need a lot of channels, you can spend as much as $140/month for over 140 channels. However that price does include HBO MAX and Showtime. Making that price a bit more worth it.

Currently, DIRECTV Stream is the only streaming service that has all of the regional sports networks – from Bally Sports and NBC Sports. It also is only the second service that offers unlimited DVR, though it does cost you an additional $10 per month. Otherwise, everyone gets 20 hours of DVR for free.

It's a pricey service, but it's no doubt worth it with the features and channels that are included here.

FuboTV

Price: Starting at $65/month
Free Trial Available: Yes, 7-days
Sign Up

FuboTV has been marketed as the streaming service for sports fans. That's because there are over 50 sports channels available on FuboTV. And that does not include regional sports networks – though it's worth mentioning that Bally Sports is not available, only NBC Sports. Overall, there are 216 channels that are available on FuboTV right now. So there's plenty to watch.

For $65/month, you're getting a pretty good deal from FuboTV. That includes 108 channels, with over 130+ events in 4K. It also has 250 hours of Cloud DVR space, and you can share with your family allowing for up to three screens simultaneously.

FuboTV does allow you up to upgrade to its "Pro" plan which is $69.99/month and it increases the Cloud DVR to 1000 hours, and gives you unlimited screens.

FuboTV does also include most local channels, this will depend on your area of course.

Hulu + Live TV

Price: $65/month
Free Trial: Yes, 7-days
Sign Up

Hulu + Live TV is one of the more popular options, because a lot of people already have Hulu. Hulu + Live TV is available for $64.99 per month (currently they are running a promo that will get you $10 off for the first three months), there's one plan and then some add-ons available.

It has 75+ top channels, which includes all of our local channels. But again, the Bally Sports regional sports networks are missing here. NBC's regional sports networks are available, however.

One feature that Hulu has that a lot of these other options do not have, is the massive on-demand library that Hulu has built up over the years. So in addition to the cloud DVR that is included with Hulu + Live TV, you also get the Hulu on-demand library. Which kind of renders the cloud DVR useless. As almost everything is on Hulu already.

Sling TV

Price: Starting at $35/month
Free Trial: No
Sign Up

Sling TV is the cheapest, on the surface, but that is because it is an a la carte option. Basically, you have two options here, Sling Blue and Sling Orange, these are both $35 per month. or you can combine them for $50 per month. That's going to get you 51 total channels if combined, which is not a lot.

However, there are plenty of add-ons available here. There's the Sports Extra for $11/month, Comedy Extra for $6/month, News Extra for $6/month, Lifestyle Extra for $6/month and a few others too. There are also some bundles you can use to keep this cheaper. But you can get up to the $60-$70 prices of the other services on this list pretty quickly.

Sling TV does offer everything about 50 hours of DVR for free. Or you can upgrade to DVR Plus for around 200 hours of recording, and that will cost you $5 per month.

Premium channels are also available on Sling TV. This includes Showtime, Starz, Epix, Cinefest, Cinemoi, Comedy Dynamics and more.

The one big caveat for Sling TV is that local channels are not available. You will get on-demand content for FOX and NBC, that will depend on your market. As for CBS and ABC, you're out of luck. But you can get an OTA antenna and watch these for free. That's a big reason why Sling TV is so much cheaper than everyone else here.

The post The Best Live TV Streaming Alternatives To YouTube TV appeared first on Android Headlines.

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Posted: 30 Sep 2021 08:01 AM PDT

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