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Alimera & pSivida + ILUVIEN = Ouch

posted Nov 11, 2011, 2:48 PM by Bryce Istvan
Today Alimera (ALIM) provided a perfect example of what happens when the FDA says no, plummeting over 75%. They recieved a Complete Response Letter (CRL) which means that the FDA felt the drug was not approvable based on the application submitted. The FDA stated that it was unable to approve the ILUVIEN NDA because the NDA did not provide sufficient data to support that ILUVIEN is safe and effective in the treatment of patients with DME (Diabetic Macular Edema)." The requested two additional clinical trials to prove safety and efficacy. The drug is still in the approval process in Europe with a decision expected in mid 2012. However, some are saying "The only question now is who merges into $ALIM's empty public shell" as reported by Adam Feuerstein on Twitter. Also taking a big hit on the news was pSivida (PSDV), losing about 50%. Alimera had licensed ILUVIEN from pSivida, who retained an interest in the drug. The news release from Reuters is below.