12/5/2008 Email

From: Miller, Daryll L
Sent: Friday, December 05, 2008 3:45 PM
To: 'Paul WILSON'
Subject: Need more information about the 2 AE subjects

I have been asked to ask you for " a good faith effort to document the clinical outcome // final diagnosis" of the 2 subjects we have been discussing, the one with DM and the one with MS. Please ask the investigators to provide any final data, especially about the change in diagnosis to Neuroborreliosis.

Daryll L. Miller, M.A.
Regulatory Health Project Manager
FDA/CBER/OVRR/DVRPA
HFM-478
1401 Rockville Pike, Suite 370N
Rockville, MD 20852
Telephone: 301-827-3070
Fax: 301-827-3532

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