Refusal

Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia

Retrieved on: 
Thursday, March 28, 2024
PSVT, Letter, Refusal, Paroxysmal supraventricular tachycardia, New Drug Application, Patient, NDA, Aes, RTF, Agency, Safety, FDA, Food, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).

Key Points: 
  • MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company’s lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
  • “We appreciate FDA’s guidance through the resubmission process.
  • We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the Agency as it reviews our application,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals.
  • The resubmission package included restructured data sets that captured timing of reported AEs and certain data files reformatted to facilitate FDA’s analyses.

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Research, American Heart Association, Letter, Arrhythmia, Refusal, Offering, Paroxysmal supraventricular tachycardia, Safety, Atrial fibrillation, New Drug Application, Patient, Shanda, NDA, Aes, Science, Net, RTF, Investment, AHA, Milestone, Revera, FDA, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.

Key Points: 
  • - FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024
    MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) --  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update.
  • There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022.
  • Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period.
  • For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period.

Milestone Pharmaceuticals Announces Plan to Resubmit NDA for Etripamil for the Treatment of PSVT

Retrieved on: 
Monday, February 26, 2024
New Drug Application, Aes, FDA, Food, Paroxysmal supraventricular tachycardia, PDUFA, Refusal, PSVT, Patient, Type, NDA, Pharmaceutical industry

MONTREAL and CHARLOTTE, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT).

Key Points: 
  • Following the previously announced receipt of a Refusal to File letter , Milestone held a Type A Meeting with FDA.
  • FDA indicated that the timing of adverse events (AEs) in question had minimal impact on the overall characterization of the etripamil safety profile.
  • The Company expects a standard NDA review period following resubmission of the NDA for etripamil for PSVT, which is planned for 2Q2024.
  • "We thank FDA for its thoughtful consideration of our materials and direction on the NDA resubmission," said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals.

Stevens Nation Responds to FDA's Refusal to File Letter, NurOwn Recipients Call for Advisory Committee Meeting

Retrieved on: 
Tuesday, November 22, 2022
Authorization, Muscle weakness, CDER, Brainstorm, Therapy, Camping, Atrophy, Eating, Refusal, FDA, Amyotrophic lateral sclerosis, Pulmonology, EAPS, Spinal cord, University of California, Irvine, Expanded access, RTF, UC, Advisory Committee, CDC, Patient, Phase, Aerospace, Walking, Motor neuron, Neurology, Brain, Life expectancy, Letter, Food, Exercise, Disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, EAP, Pharmaceutical industry, Medical device, Renewable energy, ALS

WASHINGTON, Nov. 21, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics is seeking FDA approval of its mesenchymal stem cell therapy called NurOwn for the treatment of ALS. In response to the FDA's Refusal to File letter, and as people who participated in the NurOwn trials and its Expanded Access program ("EAP"), we support Brainstorm's efforts to seek an Advisory Committee ("AdCom") meeting.

Key Points: 
  • In response to the FDA's Refusal to File letter, and as people who participated in the NurOwn trials and its Expanded Access program ("EAP"), we support Brainstorm's efforts to seek an Advisory Committee ("AdCom") meeting.
  • We must insist that the FDA allow testimony about the "clinically meaningful" changes that occurred when we received NurOwn.
  • However, the Phase III trial did meet a pre-specified secondary endpoint in a subgroup of patients with less advanced ALS.
  • The best people to attest to how NurOwn made them "feel and function" are the people who received NurOwn.

Lost Money in Y-mAbs Therapeutics, Inc.?

Retrieved on: 
Monday, October 31, 2022
Class Action Lawsuit, Professional Services, Legal, Lawyer, News, Neuroblastoma, Refusal, NASDAQ, Therapy, FDA, Woman, Medical device, Private investigator, Pharmaceutical industry, Real estate, MarketWatch

Gibbs Law Group is looking into a potential Y-mAbs Therapeutics (YMAB) Securities Class Action Lawsuit on behalf of shareholders who lost money in Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB).

Key Points: 
  • Gibbs Law Group is looking into a potential Y-mAbs Therapeutics (YMAB) Securities Class Action Lawsuit on behalf of shareholders who lost money in Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB).
  • To speak with an attorney regarding this class action lawsuit investigation, click here or call (888) 410-2925.
  • Following this news of the FDAs vote, y-mAbss stock price closed at 59% on October 31, 2022, causing significant harm to investors.
  • Our investigation concerns whether y-mAbs Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors.

Lost Money in Y-mAbs Therapeutics, Inc.?

Retrieved on: 
Thursday, October 27, 2022
Class Action Lawsuit, Professional Services, Legal, Lawyer, NASDAQ, Woman, FDA, Therapy, Refusal, News, Neuroblastoma, Private investigator, Pharmaceutical industry, Real estate

Previously, in October of 2020, the FDA had issued a Refusal to File letter for omburtamab.

Key Points: 
  • Previously, in October of 2020, the FDA had issued a Refusal to File letter for omburtamab.
  • Gibbs Law Group is looking into a potential Y-mAbs Therapeutics (YMAB) Securities Class Action Lawsuit on behalf of shareholders who lost money in Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB).
  • To speak with an attorney regarding this class action lawsuit investigation, click here or call (888) 410-2925.
  • Our investigation concerns whether y-mAbs Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors.

CytoDyn Cancels Webcast and Live Q/A Scheduled for Today

Retrieved on: 
Thursday, January 13, 2022
Oncology, AIDS, Health, Infectious Diseases, Pharmaceutical, Biotechnology, Biomarker, Calendar, Forward-looking statement, HIV, Patient, Fatty liver disease, HIV/AIDS, Human, Vaccine, Inflammation, Clinical trial, Government budget balance, Fast Track, OTCQB, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Form 10-K, BLA, COVID-19, Social conditions in Honduras, ME/CFS, Partnership, SARS, Optimism, Cirrhosis, XV, Triple-negative breast cancer, CCR5, Refusal, Standard of care, Common, NASH, Securities and Exchange Commission (Philippines), Sleep, PASC, Fatigue, HAART, Myalgia, Degenerative disease, Company, Viral load, Food, Fibrosis, NAFLD, Biologics license application, FDA, 100,000, Cell, Compliance, Security (finance), Immunoglobulin G, Risk, Pharmaceutical industry, R5, Leronlimab

CytoDyn Inc. (OTCQB: CYDY) (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced it has canceled its webcast scheduled for today, Thursday, January 13, 2022 and will provide an update at a future date.

Key Points: 
  • CytoDyn Inc. (OTCQB: CYDY) (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced it has canceled its webcast scheduled for today, Thursday, January 13, 2022 and will provide an update at a future date.
  • Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV.
  • About 30 to 40 percent of adults in the U.S. live with NAFLD, and 3 to 12 percent of adults in the U.S. live with NASH.
  • CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used as a once-weekly monotherapy for HIV-infected patients.

Government of Canada implements key measures with the Government of Quebec to address labour shortages

Retrieved on: 
Monday, January 10, 2022
Education, Agriculture and Agri-Food Canada, Growth, Temporary, ESDC, Canada Gazette, Agreement Respecting a New Relationship Between the Cree Nation and the Government of Quebec, Government, Policy, Temporary foreign worker program in Canada, Partenaires pour la souveraineté, Workforce, Minister of Employment, Workforce Development and Disability Inclusion, Municipal government in Canada, Awareness, Program, TFW, Advertising, Pressure, Attention, Employment, Refusal, COVID-19, Compliance, Commission, Occupation, Health insurance, Animal, Ridesharing company, QC, Agriculture

The occupations and sectors selected by Quebec for pilot measures have been identified following consultations with labour market stakeholders part of the Commission des Partenaires du March du Travail.

Key Points: 
  • The occupations and sectors selected by Quebec for pilot measures have been identified following consultations with labour market stakeholders part of the Commission des Partenaires du March du Travail.
  • At the conclusion of the pilot project, the Government of Canada will evaluate outcomes to help inform its future decisions.
  • That's why our government is updating the Temporary Foreign Worker Program to help address labour shortages in Quebec immediately.
  • In July 2021, the Government of Canada proposed regulations to improve protection of temporary foreign workers, which were pre-published in the Canada Gazette, Part I.

Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Retrieved on: 
Wednesday, December 8, 2021
U.S. Securities and Exchange Commission, Central nervous system, Apomorphine, NDA, ADHD, Company, Torticollis, GLOBE, OFF, Refusal, Letter, Prescription, Growth, Security (finance), Safety, Private Securities Litigation Reform Act, Food, Patient, CEO, Securities Exchange Act of 1934, New Drug Application, Epilepsy, Migraine, Depression, CNS, Central nervous system disease, Adult, FDA, NASDAQ, Regulation of tobacco by the U.S. Food and Drug Administration, Section 13, Risk, Dyskinesia, Government, RTF, Pharmaceutical industry

The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.

Key Points: 
  • The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021.
  • SPN-830 is an important product candidate which, if approved by the FDA, represents a novel approach for PD patients, said Jack Khattar, President and CEO of Supernus Pharmaceuticals.
  • We believe the continuous subcutaneous infusion of apomorphine for the treatment of motor fluctuations (OFF episodes) can be an attractive alternative for patients who are seeking less invasive options.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

CytoDyn Announces FDA Accepts Revised Rolling Review Timeline for Resubmission of its BLA

Retrieved on: 
Thursday, October 28, 2021
Fatty liver disease, Vaccine, Partnership, THE, BLA, U.S. Securities and Exchange Commission, SARS, PASC, Triple-negative breast cancer, Government budget balance, Clinical trial, Biomarker, COVID-19, Inflammation, GLOBE, Sleep, HIV, Cros, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HIV/AIDS, BLUE, Human, Cirrhosis, Security (finance), HAART, Food, Company, Biologics license application, ME/CFS, Degenerative disease, Social conditions in Honduras, Viral load, Fibrosis, Immunoglobulin G, Compliance, DRS, Common, Fast Track, Myalgia, Calendar, Suite, SEC, OTCQB, Refusal, Optimism, CMC, Fatigue, XV, Risk, Annual general meeting, Main Street, Cancer, NAFLD, CCR5, Patient, FDA, 100,000, Forward-looking statement, Standard of care, Cell, Form 10-K, NASH, Pharmaceutical industry

VANCOUVER, Washington, Oct. 27, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s revised “Rolling Review” timeline for the Company’s upcoming resubmission of its Biologics License Application (“BLA”) for leronlimab as a combination therapy for highly treatment experienced HIV patients. Rolling review enables a drug company to submit completed sections of its BLA for contemporaneous review by the FDA, rather than waiting until every section of the BLA is complete before the entire application is reviewed. The Company also announced that it expects the non-clinical and CMC sections of the BLA to be resubmitted to the FDA in November and, as previously disclosed, the clinical section of the BLA is anticipated to be completed and resubmitted during the first quarter of calendar 2022.

Key Points: 
  • Rolling review enables a drug company to submit completed sections of its BLA for contemporaneous review by the FDA, rather than waiting until every section of the BLA is complete before the entire application is reviewed.
  • Nader Pourhassan, Ph.D., CytoDyns President and Chief Executive Officer, commented, We are very pleased with the continued rolling review status of our upcoming BLA resubmission, which is expected to reduce the overall review time.
  • Recknor and Ray, have remained so dedicated over the past several months to successful resubmission of our BLA, deserve kudos for this confirmation.
  • The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer.