It's probably going to teeter totter around the $3.90-$4.10 range until the last hour or so then I say a close around $4.50. JMHO
Alimera: Iluvien To Enter National Phase Of Approval Process In Europe
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9:06 AM ET 2/28/12 | Dow Jones
DOW JONES NEWSWIRES
Alimera Sciences Inc. (ALIM) said its most advanced product, Iluvien, received a positive final assessment report from the Medicines and Healthcare products Regulatory Agency of the U.K., and will move to the next step in the approval process in Europe.
Several other countries also agreed that Iluvien, a treatment for diabetic macular edema, is approvable, the biopharmaceutical company said. The disease involves fluid retention in the back of the eye, impairing vision.
Shares of Alimera jumped 71% to $3.96 premarket while shares of its licensor pSivida Corp. (PSDV) rose 26% to $2.71.
Alimera said Iluvien will now enter the national phase of the decentralized procedure, in which the U.K. and the concerned member states of Austria, France, Germany, Italy, Portugal and Spain will each grant it a national license.
"Achieving a favorable conclusion for Iluvien in Europe is a significant milestone for Alimera and very encouraging for the many patients with this challenging chronic disease," said President and Chief Executive Dan Myers, president and chief executive. "We will continue to work closely with the U.K. and the concerned member states to ensure that Iluvien is made available to patients as soon as possible."
Alimera licensed Iluvien from pSivida, which will receive 20% of the net profit on sales if the drug is approved, plus a $25 million milestone payment.
In November, Alimera said the U.S. Food & Drug Administration has again requested additional safety and efficacy data to approve the application for Iluvien.
-By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com
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