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Biotech / Medical : SNRS- Sunrise Technologies

SNRS 0.000001000

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Nov 25 9:30 AM EST

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To: Joe who wrote (3466)	11/30/1999 8:02:00 PM
From: Kevin Podsiadlik	Read Replies (1) of 4140

I took another look at the transcript of the panel meeting but I didn't find that remark you attributed to Dr. Mascai. Nor did I find your direct quote. The person who quoted 300 eyes, 90% at 24 months was Dr. McCulley. Most interestingly, Dr. McCulley referred to the 300/24 months/90% figure as request from prior to the JULY meeting. In other words, Sunrise knew (or should have known) what the panel would ask for in terms of data and went into that meeting with considerably less than that amount. If there was some remark from Dr. Macsai to the effect of the FDA telling the panel "what is needed", I believe she was talking about an official guidance document regarding the standards for approvability. I found no such document, and as such see no reason to believe the July standards will not be intact for the January meeting. Finally, I think it's just common sense that the FDA panel would not presume to judge the content of Sunrise's presentation prior to seeing it. We as investors, however, are not bound to ignore past history and as such can make finer judgements as to the likelihood of SNRS presenting an approvable case. And so many of us have.

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