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Biotech / Medical : PSDV - pSivida Limited -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (200)	9/29/2009 1:34:12 PM
From: Arthur Radley	Read Replies (1) \| Respond to of 421

My take! 1) PSDV agreed to a 24 month time frame. 2) The issue isn't about efficacy as the drug already has a history. The issue is safety and for extended dosage regime that PSDV has agreed. 3) PSBV story is long term efficacy and safety.....without both...marketing of drug will be difficult even assuming the FDA gives them approval. As I've stated ...OP issue has to be resolved before the FDA is going to approve.(IMO) Bottomline.......in the end result the FDA is going to demand full data on ALL patients and for the extended period of time. PSDV doesn't have wiggle room.......take a look at SQNM and see what happens when a company starts fudging trial data......would be ugly for PSDV to now start touting 12 month data....a protocol has been agreed to between PSDV and the FDA.......can't change now and expect approval. (IMO)