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

0

GOOD

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:5/20/2013)... DIEGO , May 20, 2013  Dr. ... field of nucleic acid research, recently launched a new ... In with Zon ( zon.trilinkbiotech.com ), focuses on what,s ... include interviews with industry thought leaders, discussions of research ... and more. Dr. Zon (PhD Princeton ...
(Date:5/20/2013)... 20, 2013   Flexion Therapeutics , Inc. today ... to its management team as chief financial ... financial management experience with biotechnology and medical device companies. ... chief financial officer for Novavax (NASDAQ: NVAX ... than $250 million through a combination of investment funding ...
(Date:5/20/2013)... May 20, 2013 On 25-28 July, ... – in Paris - the beautiful city of lights. ... "Personalized Medicine is revolutionizing the medical world. Understanding and ... is the hallmark of this transformation. Much of the ... from the epidemiologic studies of large cohorts that do ...
(Date:5/19/2013)... Boston, MA (PRWEB) May 19, 2013 ... providing social media training online, has proudly announced that ... for small business has surpassed 175,000 views on YouTube. ... free social media and SEO tips and training for ... see my students find the YouTube tips helpful for ...
Breaking Biology Technology:Dr. Gerald 'Jerry' Zon Launches New Blog for TriLink BioTechnologies 2Flexion Therapeutics Names Frederick Driscoll Chief Financial Officer 2The International Congress on Personalized Medicine - Up Close and Personalized 2013 in Paris 2YouTube Channel on SEO Tips Surpasses 175,000 Views, Announces JM Internet Group 2
... Alfacell Corporation (OTC Bulletin Board: ACEL) today reported ... U.S. Food and Drug Administration (FDA) to discuss the ... ONCONASE rolling New Drug Application (NDA) for the treatment ... pre-NDA meeting, the FDA provided guidance to the company ...
... PUBLISHED BY UNIVERSAL , NETTLETON, Miss., Jan. 27 ... that certain unauthorized inaccurate information is being published ... website, potentially other websites and publications, and an ... company has found errors in statements concerning the ...
... Scheduled for Tuesday, February 3, 2009 SAN DIEGO, Jan. ... ) announced today that the Company will report its ... Nasdaq market closes on Tuesday, February 3, 2009. Neurocrine ... to discuss its financial results and provide a Company ...
Cached Biology Technology:Alfacell Provides ONCONASE(R) NDA Submission Update 2Alfacell Provides ONCONASE(R) NDA Submission Update 3Neurocrine Biosciences Announces Conference Call and Webcast to Present Fourth Quarter and Year End 2008 Financial Results 2
(Date:5/17/2013)... a group of proteins in the brain responsible for ... target that could increase cell survival. , The discovery, ... and published in the EMBO journal with ... new therapies for stroke and other brain diseases. , ... which identified a protein, known as SUMO, responsible for ...
(Date:5/17/2013)... An international team of scientists ... and cell movement inside a living frog embryo in ... new method to advance biological research and the search ... University and the Karlsruher Institut fr Technologie in Germany, ... U.S. Department of Energy,s Argonne National Laboratory, released the ...
(Date:5/16/2013)... ancient shorelines to predict the stability of today,s largest ice ... from three million years ago, for example when Earth ... be evidence of a high sea level due to ice ... scientists to think that if the world,s largest ice sheets ... same in our modern, progressively warming world. , However, ...
Breaking Biology News(10 mins):SUMO wrestling cells reveal new protective mechanism target for stroke 2New X-ray method shows how frog embryos could help thwart disease 2World's biggest ice sheets likely more stable than previously believed 2
... Technological University (NTU), and Israel,s number one university, ... new collaboration to jointly offer a Doctor of ... PhD degree programme is a university-wide agreement and ... Bioengineering. Significantly, the joint PhD degree will also ...
... the study and manipulation of human embryonic stem cells ... competition for a Hebrew University of Jerusalem researcher. ... Benvenisty of the Silberman Institute of Life Sciences was ... the Hebrew University of Jerusalem Board of Governors 73rd ...
... Guam,s territorial entomologist and Aubrey Moore, UOG extension entomologist, ... early June. Jackson was invited to assist in ... (Oryctes rhinoceros) population. This virus only infects rhino ... of the pest on other Pacific islands. The ...
Cached Biology News:NTU ramps up collaboration with Israel's top university 2NTU ramps up collaboration with Israel's top university 3Research on stem cells wins first prize for Hebrew University researcher 2Research on stem cells wins first prize for Hebrew University researcher 3Unusual rhino beetle behavior discovered 2