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Replies to #64726 on Biotech Values
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masterlongevity

07/29/08 5:24 PM

#64738 RE: blackcat #64726

the FDA will have to wait for 3yr data to allow Elan to adjust the 1:1000 claim. 2 of the PMLs occurred at approx. 2.5 yrs.
It will be another 6 months before any commercial pts hit that mark. the next year will be important for tysabri
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zipjet

07/29/08 7:33 PM

#64745 RE: blackcat #64726

>>I don't believe anyone would say there won't be a case of PML somewhere. However - the label, which puts the potential at 1:1000 is high. If it were accurate, there would be about 30 cases of PML by now instead of zero.

It is still a bit early to tell how big an issue PML will be. I too think 1:1000 will prove high. But I would also bet that in time we will see PML in MS patients on T alone. I take some comfort in the T Risk Management Plan. My single point of contact with T-RMP shows they take the plan very seriously.

I do think the ability to clear the system of T, should that be advisable, in just one day will encourage the neuros to treat with T.

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