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To: twentyfirstcenturyfox who wrote (11921)1/22/2003 9:04:39 PM
From: DaveAu  Read Replies (1) | Respond to of 14101
 
Hi Fox,

Did you get those numbers for the SAP program from the HC site ?

Dave



To: twentyfirstcenturyfox who wrote (11921)1/25/2003 1:05:52 PM
From: Mark Bartlett  Read Replies (1) | Respond to of 14101
 
21st,

<<This is an open-label study, being conducted in Canada, with the express approval of HC. The purpose of the study is to allow patients to be treated with WF10 through Health Canada's controlled Special Access Programme (SAP). Dimethaid is conducting the program. Health Canada has
approved this study as a compassionate use protocol. As of May 22, 2001, 36 patients (22 males and 14 females) have been enrolled. The study is ongoing.>>

I was certainly aware that there was access via the SAP, but not specifically the open label study. However, when one thinks about it, it stands to reason that if HC is going to allow the use of the drug, it seems reasonable that one would collect data from that use -- if for no other reason than to ensure it is not having any serious, unanticipated side-effects.

I am wondering if this may even be a prerequisite to get SAP approval by HC.

MB