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News Breaks
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December 27, 2010
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| 07:57 EDT |  | ALIM |
| theflyonthewall.com: | Alimera Sciences receives Complete Response Letter for ILUVIEN | | Alimera Sciences announced that it received a Complete Response Letter from the FDA regarding its New Drug Application for the investigational drug ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form. No new clinical studies were requested in the CRL. However, the FDA asked for analyses of the safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted to the FDA, to further assess the relative benefits and risks of ILUVIEN. The NDA included data through month 24. Alimera has completed month 36 of the study and is preparing the analyses the FDA requested. The FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera is in the process of compiling. :theflyonthewall.com |
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May 11, 2012
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| 06:51 EDT | | ALIM |
| | 06:50 EDT |  | ALIM |
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May 10, 2012
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| 14:50 EDT | | ALIM |
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