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Biotech / Medical : PSDV - pSivida Limited

PSDV 1.220

+14.0%

Mar 29 5:00 PM EST

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To: John McCarthy who wrote (360)	2/4/2011 11:55:30 AM
From: kenhott	Read Replies (1) of 421

Hey John and Boo. I still have a dog in this fight so I keep track of ALIM. I am not going to repeat the often stated issues with the ALIM application but I will say that they are real enough. And this update by this analyst.... as both of you well know, one has to be careful weighing the words of analysts. There are other less discussed issues with the ALIM data and I will point out one below: files.shareholder.com On page 15 you will find a chart showing baseline status, Pseudophakic vs. Phakic for patients in the drug arm of interest. You will see that for patients coming into the drug arm with natural lens (Phakic), there is JUMP up in the respond rate of about 12% between 18 months (~17%) and 24 months (~29%). This is a VERY BIG and LATE MOVE in the response rate after 18 months of drug. We know that many many more patients in the drug arm received cataract surgery than in the placebo arm during the trial period (75% surgery rate for drug vs. 23% surgery rate for placebo). It maybe reasonable to ask if cataract surgeries boosted the response rate of the drug arm? The placebo response rate at 24 months was 16%. Company is showing 24 months combined response rate of 29% for drug. We know 75% of the drug arm had cataract surgery. Baseline natural lens patient (drug) response rate was 17% at 18 months. This could be a problem. I think the EU decision is this month for this drug. Good luck and may the force be with you. I don't check this site much so this post is probably a little late.

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