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Biotech / Medical : Biotime-Nasdaq's best kept secret?
BTIM 0.00010000.0%Nov 5 1:26 PM EST
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To: Anaxagoras who wrote (818)4/2/1998 5:29:00 PM
From: CMason  Read Replies (1) of 1432
 
Care should be exercised in interpreting the changes in PDUFA. My understanding is that FDA is not required to reduce review times at all in 1998, but they need to do 25% of their reviews in 10 months or less in 1999, 50% in 2000, 75% in 2001, and achieve 100% 10 month performance in 2002. If that's correct, it's possible that Hextend will receive an FDA decision in less than 12 months, but there's no requirement on the Agency to achieve this. In my experience, FDA typically takes pretty much the full timespan they're allowed.

Also, keep in mind that the clock starts when FDA "accepts" the file, which is typically about a month after they physically receive it.

Hope this helps.

CMason
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