K-1 visa

Bonumose says FDA Sides With High Fructose Corn Syrup Producers and Against Consumers, By Suppressing Truthful Information About Tagatose

Retrieved on: 
Thursday, May 19, 2022
Diabetes, Chinese Academy of Sciences, HFCS, Public health, Tooth decay, Bias, Freedom of Information Act 2000, Dentistry, Tagatose, Food, NFP, Sickle cell disease, Solution, Health, Psicose, World Economic Forum, Crop protection, Infant, Method, FDA, Philosophy, Hyperglycemia, Industry, Ice cream, K-1 visa, Time, Information, Dietary fiber, Dietary supplement, Immunity, Freedom, Dental plaque, Adoption, HMF, POLITICO, Clostridioides, Fructose, Science, Internal, CEO, Pharmaceutical industry

Internal FDA documents discovered via the Freedom of Information Act indicate a potential FDA bias against health-focused innovation and in favor of industrial corn sweetener producers.

Key Points: 
  • Internal FDA documents discovered via the Freedom of Information Act indicate a potential FDA bias against health-focused innovation and in favor of industrial corn sweetener producers.
  • Tagatose feeds beneficial bacteria in the gut, which makes it healthy for the gut microbiome.
  • If the FDA actually cared about human health, it would encourage, not discourage, the broad adoption of tagatose.
  • Beyond food ingredients, Bonumose also is developing enzyme solutions for dietary supplements, crop protection, animal nutrition, and other globally-significant industries.

United Therapeutics Corporation Reports First Quarter 2022 Financial Results

Retrieved on: 
Wednesday, May 4, 2022
Research, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Pulmonary hypertension, U.S. Securities and Exchange Commission, CRL, Forward-looking statement, Private Securities Litigation Reform Act, Eli Lilly and Company, Employment, K-1 visa, Pharmacokinetics, Transplant, FDA citizen petition, Idiopathic pulmonary fibrosis, Company, NDA, Safety, PAH, WHO, Patient, FVC, Trial of the century, Security (finance), Review, Chronic obstructive pulmonary disease, Webcast, Program, Creativity, United Therapeutics, FDA, Degenerative disease, Risk, Annual report, Exhibit, PBC, STAP, ETR, IPF, Income, Sale, Hypertensive emergency, Citizenship, SEC, Goal, Research, Nature, Online gambling, Pharmaceutical industry, Medical device, Treprostinil

Income tax expense for the three months ended March 31, 2022 and 2021, was $68.8 million and $4.2 million, respectively.

Key Points: 
  • Income tax expense for the three months ended March 31, 2022 and 2021, was $68.8 million and $4.2 million, respectively.
  • We will host a webcast to discuss our first quarter 2022 financial results on Wednesday, May 4, 2022, at 9:00 a.m. Eastern Time.
  • ORENITRAM, REMODULIN, REMUNITY, TYVASO, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.
  • TYVASO DPI is a trademark of United Therapeutics Corporation.

Update on Tyvaso DPI™ New Drug Application

Retrieved on: 
Thursday, February 24, 2022
GLOBE, United Therapeutics, Investor, Pharmacy, MannKind Corporation, Regulation of tobacco by the U.S. Food and Drug Administration, New Drug Application, Internet, Therapy, Company, Review, Professional corporation, Food, Eastern Time Zone, FDA, Patient, NDA, K-1 visa, SEC, Pharmaceutical industry, Treprostinil

This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the timing for FDA action regarding Tyvaso DPI.

Key Points: 
  • This press release contains forward-looking statements that involve risks and uncertainties, including statements regarding the timing for FDA action regarding Tyvaso DPI.
  • Tyvaso DPI is an investigational combination product that is not approved for any use in any country.
  • The Tyvaso DPI tradename is pending final FDA review.
  • TYVASO DPI is a trademark of United Therapeutics Corporation.

FDA Denies Citizen Petitions Filed on Behalf of Short Selling Clients

Retrieved on: 
Thursday, February 10, 2022
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FDA also denied four supplements to the August 2021 Citizen Petition.

Key Points: 
  • FDA also denied four supplements to the August 2021 Citizen Petition.
  • FDA also denied a September 2021 Citizen Petition, and a supplement, that were also filed by the same attorney on behalf of short-selling clients.
  • I think the message may be that the FDAs citizen petition privilege is not to be trifled with by stock market participants.
  • This Phase 3 program is being conducted under Special Protocol Assessments (SPA) from FDA.

Science Journal Finds No Evidence to Support Claims of Data Manipulation in 2005 Publication

Retrieved on: 
Tuesday, December 21, 2021
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Editor-in-Chief States: After Careful Examination of These Original Material, Neuroscience [Journal] Found No Evidence of Manipulation of the Western Blot Data or Other Figures of This Publication.

Key Points: 
  • Editor-in-Chief States: After Careful Examination of These Original Material, Neuroscience [Journal] Found No Evidence of Manipulation of the Western Blot Data or Other Figures of This Publication.
  • AUSTIN, Texas, Dec. 21, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc., (Nasdaq: SAVA) a biotechnology company, has been informed by Neuroscience journal there is no evidence to support claims of data manipulation in a 2005 paper1 authored by the Company and its scientific collaborators.
  • After careful examination of these original material, Neuroscience found no evidence of manipulation of the Western blot data or other figures of this publication.
  • In November 2021, Cassava Sciences reported that a different science journal (i.e., Journal of Neuroscience) also found no evidence to support allegations of data manipulation in an article it published in 2012.

Review by Journal of Neuroscience Shows No Evidence of Data Manipulation in Technical Paper Foundational to Cassava Sciences’ Lead Drug Candidate

Retrieved on: 
Thursday, November 4, 2021
Safety, Science, LLP, Research, Ethics, COPE, FDA citizen petition, Drug development, The Journal of Neuroscience, Committee on Publication Ethics, FDA, Food, SEC, K-1 visa, Review, Risk, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Annual report, Company, Intention, CEO, COVID-19, Solution, News, Nasdaq, GLOBE, Journal, Pharmaceutical industry, Security (finance)

The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Companys lead drug candidate for the proposed treatment of Alzheimers disease.

Key Points: 
  • The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Companys lead drug candidate for the proposed treatment of Alzheimers disease.
  • In response to this and similar on-line allegations, the Journal of Neuroscience requested raw data for the article, including images of original, uncropped Western blots.
  • Having received that data and completed its review, the Journal of Neuroscience states: No evidence of data manipulation was found for Western blot data.
  • In response to allegations of data manipulation in JNeurosci 2012;32:9773-9784 the Journal requested raw data, including images of original, uncropped Western blots.

CASSAVA SCIENCES DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Cassava Sciences and Encourages Investors to Contact the Firm

Retrieved on: 
Monday, October 25, 2021
Legal, Professional Services, Cassava, Court, Person, NASDAQ, FDA, Telephone, K-1 visa, P.C, Cognition, District court, News, Lists of schools in England, Jeanne Eagels, FDA citizen petition, Pharmaceutical industry

Investors have until October 26, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until October 26, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Cassava Sciences lead therapeutic product candidate during the Class Period was simufilam, a small molecule drug designed to treat Alzheimers disease.
  • On this news, the price of Cassava Sciences common stock fell approximately 32%, damaging investors.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

CASSAVA DEADLINE ALERT: Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Cassava To Contact Him Directly To Discuss Their Options

Retrieved on: 
Sunday, October 24, 2021
LLP, Court, Patient, NASDAQ, FDA, Food, K-1 visa, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Company, Woman, Cognition, Clinical trial, Advertising, News, GLOBE, FDA citizen petition, Animal, Pharmaceutical industry

If you suffered losses exceeding $100,000 investing in Cassava stock or options between February 2, 2021 and August 24, 2021 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.

Key Points: 
  • If you suffered losses exceeding $100,000 investing in Cassava stock or options between February 2, 2021 and August 24, 2021 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Delaware, Pennsylvania, California and Georgia.
  • Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Cassavas conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

CASSAVA SCIENCES 96 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess Of $100,000 of Lead Plaintiff Deadline in Class Action Lawsuits Against Cassava Sciences, Inc. - SAVA

Retrieved on: 
Saturday, October 23, 2021
Legal, Professional Services, Court, Special warfare combatant-craft crewmen, Food, K-1 visa, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LLC, Company, District court, News, KSF, Lists of schools in England, Private investigator

These actions are pending in the United States District Court for the Western District of Texas.

Key Points: 
  • These actions are pending in the United States District Court for the Western District of Texas.
  • Cassava and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
  • On this news, the Companys stock price plummeted approximately $37 per share, or 32%, on unusually high trading volume.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nations premier boutique securities litigation law firms.

CASSAVA DEADLINE ALERT: Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Cassava To Contact Him Directly To Discuss Their Options

Retrieved on: 
Sunday, October 10, 2021
NASDAQ, Company, Conference, Food, GLOBE, Cognition, LLP, FDA, News, Advertising, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, K-1 visa, Patient, Clinical trial, Court, FDA citizen petition, Woman, Cryptocurrency, Pharmaceutical industry

If you suffered losses exceeding $50,000 investing in Cassava stock or options between February 2, 2021 and August 24, 2021 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.

Key Points: 
  • If you suffered losses exceeding $50,000 investing in Cassava stock or options between February 2, 2021 and August 24, 2021 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext.
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Delaware, Pennsylvania, California and Georgia.
  • Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Cassavas conduct to contact the firm, including whistleblowers, former employees, shareholders and others.