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Biotech / Medical : IMNR - Immune Response
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To: margie who wrote (1379)6/8/1999 2:36:00 PM
From: barnsbox  Read Replies (1) of 1510
 
Thanks Margie for your interesting synopsis on the current status of Remune. Question.. I understand that if the Spanish trial shows a statistically significant reduction in viral load that this data may be used to file with the FDA in the USA also (in addition to Europe). I think that the FDA needs two trials that study viral loads as markers; and they already have the one from the recent halted trial (250 patient/preselected random). Can you comment on the possibility of filing in the United States without the need of the separate 48 week trial currently planned for next year if Spain data meets the viral load parameters? In other words could IMNR use the Spanish study in the domestic approval process? Thanks.
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