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."
Arpida will host a conference call to discuss this news release, 27
|SOURCE Arpida Ltd.|
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