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Biotech / Medical : SNRS- Sunrise Technologies

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Nov 25 9:30 AM EST

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To: Kevin Podsiadlik who wrote (3473)	12/1/1999 8:42:00 PM
From: Joe	Read Replies (1) of 4140

No, I am not talking about page 101. While the original guidance document did not include hyperopia, the draft guidance did. That is part of what he was telling the panel regarding LTK. If you have found the guidance document at the FDA website, the draft guidance is available in the same place. Also go back to the ODP meeting addressing the guidance and review the transcript. My DD included travel from California to D.C. to attend the ODP so that I would have a first hand understanding of what transpired and gain insights from the participants. Of course, I thought the trip would include a significant party. Well, a six month delay has not been too bad. Kevin, I am not going to pull all the links to the FDA's site for you. That would be aiding and abetting the enemy, but I do appreciate the reasoned dialog as compared to Tony's yelling 'POS, cover at $1'. Joe

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