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Biotech / Medical : biotech firesales
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From: John McCarthy10/18/2013 11:30:31 AM
   of 3661
 
PSDV down about 20% - the FDA rejected ILUVIEN again .....

6:35AM pSivida reports Complete Response Letter from FDA for ILUVIEN; NDA could not be approved in its present form; results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients ( PSDV) 3.80 : Co announced that its licensee Alimera Sciences (ALIM) as received a Complete Response Letter (CRL) for the New Drug Application (NDA) for ILUVIEN from the FDA. Identifying concerns regarding the benefit to risk and safety profiles of ILUVIEN, the FDA stated that the NDA could not be approved in its present form. To address the clinical and statistical deficiencies identified, the FDA indicated that results from a new clinical trial would need to be submitted, together with at least 12 months of follow-up for all enrolled patients. The FDA suggested that a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee may be of assistance in addressing the deficiencies identified above.
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