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Biotech / Medical : Texas Biotech (TXB)
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To: Dave Yenne who wrote (544)1/30/1998 9:15:00 PM
From: Marshall  Read Replies (2) of 834
 
I really know very little about these FDA matters but from what I can see it appears TXB had some additional data from another study they wanted to add for consideration and the FDA cut some slack on an allowable time limit, not an actual date at which they would decide.

>>>" The FDA has extended the review time in order to consider new data from a follow-on study (ARG-915) in the same patient population as those participating in the pivotal study, ARG-911. Based upon the extension to review additional data, the Company still expects to receive a decision from the FDA within its original time frame of the end of second quarter 1998."

Someone around here is bound to be able to put it into simple wording.
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