CRIS, Curis (formerly CBMI) Message Board

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Biotech / Medical : CRIS, Curis (formerly CBMI)

CRIS 1.200

+2.6%

10:06 AM EST

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To: Thomas Stewart who wrote (210)	7/17/1999 12:26:00 AM
From: David Evans	Read Replies (1) of 668

>>The FDA and the EMEA have up to 45 days to decide if the submissions are acceptable for filing." I believe the 45 days is to determine if all the information submitted is sufficient to make a ruling later in the year. October keeps getting mentioned on the yahoo board as a general time frame for approval or disapproval. The 45 day ruling would be significant because it would signal the end of the delays OP-1 has had, leaving the ball in the FDA'a hands. Dave

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