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To: Rick Strange who wrote (1386)10/11/1998 1:20:00 AM
From: yosi s  Respond to of 1491
 
There were some studies that were monitored, which due to efficacy shown were halted in the middle and were approved.

It would be very intresting to see te results of the last cohort of phase 2, now on going, if it continue with the same then it will be very intresting. as the severly affected patients outcome was bordering significant numbers. and by adding 20 more patients thing will be more evident. and easy going into phase 3.It will almost be a formality. (though it still has to take place.)



To: Rick Strange who wrote (1386)10/12/1998 12:20:00 AM
From: Ariella  Read Replies (2) | Respond to of 1491
 
Dear Rick -- The Orphan Drug Act defines orphan products as ones used to treat diseases or conditions affecting fewer than 200,000 persons in the United States. Such small patient populations reduce profit potential for sponsors, so the act grants special privileges and
marketing incentives. <-- see quoted material
fda.gov

If we so tightly defined the target audience of HU-211 to fit this category, we would slice away much of the eps growth projected for the company in 3 to 5 years.