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Repligen Announces FDA And EMA Approval Of Re-analysis Of Images From Phase 3 Trial O
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<blockquote data-quote="tD33NAt" data-source="post: 2171242" data-attributes="member: 124445"><p>Repligen Corporation (Nasdaq: RGEN) announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved the Company's proposal to re-analyze the images from our Phase 3 study to establish the utility of RG1068, synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas (Phase 3 re-read). The FDA and EMA have agreed to the Phase 3 re-read based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 data...<a href="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/0/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/0/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a></p><p><a href="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/1/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/1/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a></p><p></p><p><img src="http://feeds.feedburner.com/~r/mnt/healthnews/~4/fOfDDCBq01E" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></p><p></p><p><a href="http://feedproxy.google.com/~r/mnt/healthnews/~3/fOfDDCBq01E/3Dh4" target="_blank">More...</a></p></blockquote><p></p>
[QUOTE="tD33NAt, post: 2171242, member: 124445"] Repligen Corporation (Nasdaq: RGEN) announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved the Company's proposal to re-analyze the images from our Phase 3 study to establish the utility of RG1068, synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas (Phase 3 re-read). The FDA and EMA have agreed to the Phase 3 re-read based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 data...[URL="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/0/da"][IMG]http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/0/di[/IMG][/URL] [URL="http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/1/da"][IMG]http://feedads.g.doubleclick.net/~a/iF2ObpFaQuux94yg9hW3ZeX0FFQ/1/di[/IMG][/URL] [IMG]http://feeds.feedburner.com/~r/mnt/healthnews/~4/fOfDDCBq01E[/IMG] [url=http://feedproxy.google.com/~r/mnt/healthnews/~3/fOfDDCBq01E/3Dh4]More...[/url] [/QUOTE]
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