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To: john.d who wrote (6901)3/7/2001 9:03:04 PM
From: Mark Bartlett  Read Replies (2) | Respond to of 14101
 
john,

<<I suspect it might be the part were Kuhne mentions that they are going to show the unblinded results to the FDA.>>

Maybe I am the one blinded, but the only reference I see, regarding showing the FDA any data is:

A blinded interim analysis of this trial will be conducted soon and presented to the FDA

Is there something I missed, because the copy I have says BLINDED? I am not trying to be funny here, I really am asking if I missed something in the PR.

Assuming I did not, showing the FDA a blinded interim study would, IMO, only be done if there were two very clear and distinct groups emerging in the trial. I personally believe that to be the case.

If I missed something, please let me know.

Best to all,

Mark



To: john.d who wrote (6901)3/8/2001 1:00:00 AM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
Hi John,

Personally, I don't see that reference to the FDA as being too sensitive. Who knows what is going on behind the scenes right now though?

I noticed that release can still be found when searching the web:

oxochemie.com

They've just taken away the link to it.

joe