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Biotech / Medical
Psivida (PSDV) PDUFA Date on October 17. 2013
An SI Board Since August 2013
Posts SubjectMarks Bans Symbol
1 0 0 PSDV
Emcee:  BioHero Type:  Moderated
Your big Opp to make quick money with upcoming FDA decision . GL

This Low Float Stock will hit $6++ before FDA decision on October 17 ...PSDV will move into double digits easily with FDA approval for Blockbuster Candidate Iluvien .There is NO FDA approved drugs for DME (Diabetic Macular Edema) .

Upon US approval of Iluvien, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug by Alimera.

DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.The U.S. market for DME is $1.5 billion to $4 billion.

Iluvien was launched commercially in the United Kingdom and Germany in April and May 2013, respectively, and Alimera expects to launch Iluvien in France in the first quarter of 2014.

Psivida (PSDV)

Market Cap: $83 M
Cash: $24 M
Price: $3.56

Shares Out: 26.8 M ( 10.4 M shares held by Insiders & Institutions)

Slide Presentation (July 2013)

files.shareholder.com

From latest Q-results :

“We are very pleased that the FDA has accepted Alimera Sciences’ recently resubmitted New Drug Application for ILUVIEN® for chronic Diabetic Macular Edema (DME) and has set a PDUFA target date of October 17, 2013. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera,” said Dr. Paul Ashton, President and CEO of pSivida. “Further good news was Alimera’s recent announcements of the commercial launch of ILUVIEN in Germany and for private pay and privately insured patients in the U.K. Alimera also reported that a simple patient access scheme for ILUVIEN is being evaluated by the UK’s National Institute for Clinical Excellence (NICE), and, if accepted, ILUVIEN would be funded throughout England and Wales by the National Health System.”

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Institutions Buying :

data.cnbc.com

Top Four Shareholders in PSDV

Allan Gray ...2.6M
Orbis Investment ...2.2M
Pfizer Inc ....1.9M
North Run ...1.6M

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