Navigation Links
Arpida Provides Update on Progress of New Drug Application for Intravenous Iclaprim
Date:2/26/2008

REINACH, Switzerland, February 26 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today reported that the rolling submission of the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI) will be completed within the next few weeks.

Arpida has agreed with the U.S. Food and Drug Administration (FDA) to file the NDA in a rolling process. Using a 'rolling NDA' allows modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Both the rolling NDA and the electronic format could potentially facilitate the review process.

Dr Khalid Islam, President and CEO of Arpida Ltd., commented: "Completing the submission of the NDA as soon as possible, while at the same time maintaining high standards of quality, remains our highest priority. Unfortunately, some of the data to be included in the NDA package were delivered later than anticipated. These delays were amplified by the additional processing steps that need to be taken for the electronic format in which we are filing, such as the incorporation of hyperlinks between the different parts of this huge and complex data package. We have only limited reference data regarding such projects and we underestimated the magnitude of the additional processing steps. Our development team and our external partners have been doing their utmost to complete the project within the February timeline. Rushing through the final processing procedure could jeopardise the quality. We strongly believe that safeguarding a high quality level at this crucial stage of iclaprim's development process is in the best interest of our stakeholders in the longer term. Based on the current status of the project, we anticipate the filing to be completed within the next few weeks."

Conference Call

Arpida will host a conference call to discuss this news release, 27

February
'/>"/>

SOURCE Arpida Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Arpida Interim Results for six Months to 30 June 2007
2. Arpida Invited to Present Preclinical Data on Novel Topical Antibiotic AR-2474 at ICAAC
3. Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC
4. Arpida Presents Preclinical Data on AR-2474 at ICAAC
5. Arpida Presents Data on Iclaprim at Scientific Congress in Germany
6. Arpida-Supported CME Symposium Available Online
7. Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim
8. Arpida Reports Progress in Pivotal Phase III Trial With TLT Treatment in Onychomycosis
9. CardioDynamics Provides 2007 Shareholder Meeting Update
10. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
11. NxStage Medical Provides Update on Medisystems Acquisition
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... September 30, 2014 Fast, ... of chemistry in documents ChemAxon ... and consulting services for life science research, launches ... generate Markush structures from documents. Markush ... property, however generating and understanding Markush structures is ...
(Date:9/30/2014)... Los Angeles, CA (PRWEB) September 30, 2014 ... Separation (EWS), the high-speed, chemical-free process to clean up ... letter to shareholders, CEO Riggs Eckelberry reported on the ... West Texas, at a site provided by partner ... ramped up to 1000 barrels per day (bpd) and ...
(Date:9/30/2014)... 30, 2014 BioHealth Innovation, Inc. ... biohealth innovations and increasing access to early-stage funding in ... venture capitalist, Tania Fernandez , Ph.D., has joined ... will be a member of the management team for ... to $50 million in seed and early-stage equity investments ...
(Date:9/30/2014)... Boston, MA (PRWEB) September 30, 2014 ... Core Facility Management Benchmarking study which focuses on ... the common challenges core managers face today. , In ... were revealed. One of note is the year-over-year decrease ... contributions. Core managers appear to be feeling the constraints ...
Breaking Biology Technology:ChemAxon Introduces ChemCurator for Chemical Information Extraction and Markush Structure Creation 2OriginOil, Inc. Report to Shareholders: Blue Gold in West Texas 2Seasoned Life Sciences Venture Capitalist Tania Fernandez Joins BHI to Help Manage New BioHealth Gap Fund 2iLab Solutions Announces the Results of the 2014 Core Facility Benchmarking Study 2iLab Solutions Announces the Results of the 2014 Core Facility Benchmarking Study 3
... Inc. (Nasdaq: INSM ), a developer of follow-on ... 23, 2009, NASDAQ issued a notice further extending the suspension ... and those rules requiring a minimum market value of publicly ... through Friday, July 17, 2009, and the original rules will ...
... CALGARY, March 25 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ... the completion of patient enrolment in its U.K. ... intravenous administration of REOLYSIN(R) in combination with gemcitabine ... and head and neck. The principal investigators are ...
... 25 Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: ... of Shareholders held on Tuesday, March 24, 2009.At the ... of shares of authorized stock (including an increase in ... proposal to increase the number of shares available for ...
Cached Biology Technology:Insmed Announces That NASDAQ Further Extends Temporary Suspension of Minimum Bid Closing Price Rule 2Oncolytics Biotech(R) Inc. Completes Enrolment in Combination REOLYSIN(R)/Gemcitabine Trial 2Oncolytics Biotech(R) Inc. Completes Enrolment in Combination REOLYSIN(R)/Gemcitabine Trial 3Cell Therapeutics, Inc. Reports Outcome of Special Meeting of Shareholders 2
(Date:9/30/2014)... scientists and engineers, led by Clemson University associate ... million grant from the U.S. Department of Energy,s ... a direct positive impact on South Carolina in ... radioactive contaminants. , "Understanding the scientific and engineering ... aspects of nuclear technologies is imperative if South ...
(Date:9/30/2014)... England Journal of Medicine reports positive results of ... against the subset of lung cancer marked by rearrangement ... 50 patients with advanced non-small cell lung cancer testing ... 72 percent, with 3 complete responses and 33 partial ... for the disease to resume its growth after being ...
(Date:9/30/2014)... in German . ... expensive foods in the world. Because they grow underground, people ... distinctive smell of truffles is not only of interest to ... direction of the Goethe University Frankfurt have discovered that the ... which are trapped inside truffle fruiting bodies. , White truffles ...
Breaking Biology News(10 mins):Researchers get $5.25 million to advance nuclear technologies in South Carolina 2NEJM: Crizotinib effective in Phase 1 trial against ROS1 lung cancer 2On the trail of the truffle flavor 2
... the heels of his discovery in Montana of the first ... Martin has found evidence of more dinosaur burrows this ... Australia. The find, to be published this month in ... dinosaurs of different species, in different hemispheres, and spanned millions ...
... BIRMINGHAM, Ala. The American Heart Association has pledged ... at Birmingham (UAB) biomedical engineering undergraduate students who are ... using hand-held remote controls from the Nintendo Wii video ... Islam and Zach Clark began work on the project ...
... available in German . , Infections ... often caused by bacteria called Pseudomonas aeruginosa. Once they ... virulence factors and can enter into a slimy state, ... of quorum sensing, which cells use to "sense" cell ...
Cached Biology News:Down Under dinosaur burrow discovery provides climate change clues 2Down Under dinosaur burrow discovery provides climate change clues 3UAB students' Nintendo Wii CPR earns American Heart Association support 2A matter of density, not quantity 2
DryStrip aligners, 4. Category: Electrophoresis Systems & Standards & Reagents, IEF & SDS-PAGE & 2-D Electrophoresis, Multiphor II Kits & Components and Accessories....
...
... deuterium atoms at the 3, 3', 4, ... use as an internal standard for the ... spectrometry. PGE1 is the theoretical cyclooxygenase metabolite ... virtually undetectable in the plasma of normal ...
Assay Diluent Trial Pack, 4 x 100 mL...
Biology Products: