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Re: DewDiligence post# 75025

Thursday, 03/26/2009 1:11:10 AM

Thursday, March 26, 2009 1:11:10 AM

Post# of 257253
Sandrock's quote - " ......... since Tysabri's reintroduction the PML rate is about 1 in 4,000 over 12 months of exposure"

Dew's quote " 1 in 4,000 during the initial 12 months of treatment"


Actual facts - Since reintroduction ONLY ONE patient out of approx 40,000 currently on Tysabri or over 55,000 exposed has developed PML during the INITIAL 12 months of treatment. That ONE patient developed PML after the 12th infusion. The remaining 4 confirmed cases occurred (2) after 14 months, (1) after 17 months, and (1) after 26 months.


In summary, we have had 5 confirmed cases of PML out of approx 20,000-25,000 patients with greater than 12 months of exposure on drug (1 out of 4,000-5,000). No cases of PML have been confirmed in any patients with under 12 months of exposure.

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