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Biotech / Medical : SNRS- Sunrise Technologies
SNRS 0.0000010000.0%Jun 6 11:01 AM EST

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To: bob beck who wrote (3463)11/30/1999 4:51:00 PM
From: Kevin Podsiadlik  Read Replies (1) of 4140
 
The original 300 request was ridiculous and the FDA agreed.

Is there any official source for this remark or was this just part of the "biased panel" theory?

You don't really think the FDA would let them back before the panel if they hadn't met their requirements, do you??

I doubt the July panel had a direct say-so on when SNRS would be granted a second review. All they could do was suggest what SNRS should have to prevent the next trip from being a waste of everybody's time. SNRS obviously met the "entrance requirements" for a panel review in July, so I see no reason why they wouldn't meet those same requirements in January.
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