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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

+14.0%

Mar 29 4:00 PM EDT

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From: John McCarthy	12/28/2010 12:47:07 PM
	of 421

Oppenheimer research report In the report, Oppenheimer writes "On 12/23, ALIM received an FDA complete response letter (CRL), delaying approval of Iluvien for diabetic macular edema (DME). Importantly, the FDA did not request an additional trial, suggesting the agency did not find major inadequacies with the ph.III FAME trials. The agency requested full 36-mo. FAME data, and we believe these results will likely be consistent with the positive 24-mo. results. Based on our discussions with ALIM, we believe the new data analyses, and resolution of outstanding manufacturing issues, should be completed for a late 1Q11 NDA refiling. Although the CRL is a real setback, we would buy ALIM on significant weakness, as we believe Iluvien will likely be approved by 4Q11." Oppenheimer maintains its Outperform rating and has lowered the price target from $16 to $14. messages.finance.yahoo.com

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