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Vaccines, Blood & Biologics

11/24/2008 Email

From: Miller, Daryll L
Monday, November 24, 2008 2:38 PM
Daemer, Richard J.
RE: Telecon Follow-Up

Hi Paul,

A few people have asked me to have you send a translation of the German file you sent because none of us can read it. I see you have sent another e-mail within the last half hour and I will respond to that one also.


From: Paul WILSON []
Sent: Monday, November 24, 2008 10:50 AM
To: Miller, Daryll L
Cc: Daemer, Richard J.
Subject: Telecon Follow-Up

Hi Daryll:

I hope you had a good weekend. Thanks again to you and others at the Agency for the telecon on Friday. The discussion was most productive and we believe went a long way towards developing a mutually acceptable PI.

As a follow-up, I am sending you the subject record summaries and test / lab results of the two subjects discussed during the telecon. FYI, I have attached information on one subject (dermatomyositis) here & will send the 2nd subject’s information in a separate email. As you recall, Jeff Roberts stated that this information was the most time-sensitive, so we wanted to get it to the Agency ASAP. I acknowledge that the test / lab results are in German, but hope the total information will be adequate to address Jeff’s questions. Please let us know if you have further questions.


Best, Paul

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