UPDATE: Amarin (AMRN) Said Website on AMR101 "Inadvertent", "Outdated"
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(Updated - July 19, 2012 1:51 PM EDT)
Amarin Corporation plc (Nasdaq: AMRN) said website data on AMR101 was "inadvertent, "outdated."
From the filing:
On July 19, 2012, information related to AMR101, Amarin Corporation plc’s (“Amarin”) lead product candidate, and its pending regulatory review with the U.S. Food and Drug Administration (“FDA”) was inadvertently published through a draft website that is under design by third parties on behalf of Amarin. The information was outdated and should not be relied upon as accurate. AMR101 review at FDA is still pending. No determinations have been made by FDA on its review of the AMR101 New Drug Application (“NDA”).
Amarin plans to announce news related to a final determination by FDA on the pending AMR101 NDA when appropriate. As previously announced, the FDA has assigned a Prescription Drug User Fee Act date of July 26, 2012 as the target date for the completion of FDA review of the pending AMR101 NDA. Please refer to Amarin’s other filings with the U.S. Securities and Exchange Commission for a complete discussion regarding the risks and uncertainties regarding the pending AMR101 NDA.
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Amarin Corporation plc (Nasdaq: AMRN) said website data on AMR101 was "inadvertent, "outdated."
From the filing:
On July 19, 2012, information related to AMR101, Amarin Corporation plc’s (“Amarin”) lead product candidate, and its pending regulatory review with the U.S. Food and Drug Administration (“FDA”) was inadvertently published through a draft website that is under design by third parties on behalf of Amarin. The information was outdated and should not be relied upon as accurate. AMR101 review at FDA is still pending. No determinations have been made by FDA on its review of the AMR101 New Drug Application (“NDA”).
Amarin plans to announce news related to a final determination by FDA on the pending AMR101 NDA when appropriate. As previously announced, the FDA has assigned a Prescription Drug User Fee Act date of July 26, 2012 as the target date for the completion of FDA review of the pending AMR101 NDA. Please refer to Amarin’s other filings with the U.S. Securities and Exchange Commission for a complete discussion regarding the risks and uncertainties regarding the pending AMR101 NDA.
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