What is the medical procedure for NDA
Duska Therapeutics plans NDA application for ATPace (TM) according to 505 (b) (2)
LA JOLLA, Calif., Feb. 7 / PRNewswire / - Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) (hereinafter "Duska" or the "Company"), a biotechnology company that manufactures medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor processes , announced today that the company's senior management and clinical and regulatory advisories met on April 16 with members of the US Food and Drug Administration's Cardiovascular and Renal Drugs Division. The purpose of the meeting was to discuss a suitable approval process for the application for approval for the sale of ATPace (TM) as an antiarrhythmic drug. The drug is intended to directly counteract acute paroxysmal supraventricular tachycardia (PSVT).
Based on the discussions during the meeting and the previous written correspondence between Duska and the FDA, the company has come to the conclusion that the FDA has submitted an NDA (New Drug Application) application for ATPace (TM) pursuant to Section 505 (b) (2) on condition that the company provides further clinical data. An NDA application under 505 (b) (2) is based in part on relevant, published results that come from third parties and not from the company itself.
Dr. James Kuo, Duska Chairman and CEO, stated, "I am delighted to announce that the meeting with the FDA has been positive and constructive. We have already taken action with Cato Research, Inc., our contract research organization in order to provide the further data required by the FDA. An NDA application according to 505 (b) (2) would significantly accelerate the possible approval of ATPace (TM), "continued Kuo.
Dr. Amir Pelleg, President and Chief Scientific Officer of Duska, said: "Our goal was to bring the first ATP-based drug to market in the United States, and I think after this meeting that we are now very much on that goal Various formulations of ATP, the active ingredient in ATPace (TM), have been used in Europe to treat PSVT for over 50 years and I am confident that our drug will have a safety and efficacy profile similar to the European formulation . "
Information about ATPace (TM)
ATPace (TM) is Duska's intravenous pharmaceutical formulation of ATP for the acute treatment of paroxysmal supraventricular tachycardia (PSVT). Numerous published clinical studies have shown that the heartbeat slowing effect of ATP, in particular its temporary blocking of the atrioventricular node conduction, counteracts a re-entry PSVT in which the atrioventricular node is affected.
Information about the PSVT
Paroxysmal supraventricular tachycardia (PSVT) is a fast, regular heartbeat that originates in the atrium of the heart. There are an estimated 89,000 new cases annually in the United States alone. PSVT is one of the most common cardiac arrhythmias.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc., an emerging biotechnology company based in La Jolla, California, specializes in the development of therapeutics, medical devices, and diagnostics related to adenosine 5'-triphosphate (ATP) and cell surface P2 receptors ( P2R). Duska owns or has exclusive licensing rights to a number of proprietary products, four of which are currently in various stages of development for treating and diagnosing certain cardiac arrhythmias, improving sperm motility, treating chronic obstructive pulmonary disease, and reducing the toxic effects of radiation exposure are located. Additional information is available on the Duska website at http://www.duskatherapeutics.com.
This press release contains forward-looking statements within the meaning of Section 21E of the applicable version of the Securities Exchange Act of 1934 that are subject to risks and uncertainties that could cause actual events or results to differ materially from those anticipated in the forward-looking statements Events or results described may differ from statements. The forward-looking statements are based on current expectations, estimates and forecasts of the company management. For forward-looking statements, Duska claims the protection of the "Safe Harbor" provisions for forward-looking statements. Such forward-looking statements can be identified by words such as "expects," "anticipates," "intends," "plans," "believes," "seeks", "estimates" and variations thereof. All statements in this press release that relate to Duska's future prospects are forward-looking statements, including statements that the company believes the FDA will submit a New Drug Application (NDA) under Section 505 (b) ( 2) will review for ATPace (TM) subject to the Company providing additional clinical data. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements. Additional risks and uncertainties are set out in Duska's most recent filings with the SEC, such as the most recent annual report on Form 10-KSB, all quarterly reports on Form 10-QSB, and all current reports on Form 8-K that have appeared since the last report Form 10-KSB submitted. Copies of these filings are available on the SEC's website at http://www.sec.gov. All forward-looking statements are based on information that was available to Duska at the time of their publication. Duska assumes no obligation to publicly update forward-looking statements as a result of new information, future events or for other reasons, unless this is required by law.
Inquiries & contact:
Dr. med. James S. Kuo, M.B.A., Duska Chairman and CEO
Therapeutics, Inc., Tel: + 1-858-551-5700, Fax: + 1-858-551-5704,
Email: [email protected]
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