Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: Joe who wrote (3466)	11/30/1999 7:49:00 PM
From: bob beck	Respond to of 4140

Thanks Joe. Saved me some digging. bob

To: Joe who wrote (3466)	11/30/1999 8:02:00 PM
From: Kevin Podsiadlik	Read Replies (1) \| Respond to 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.