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Old 01-21-2012, 04:01 PM
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Riverwild Riverwild is offline
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Join Date: May 2007
Location: Heah!
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15 yr Member
Riverwild Riverwild is offline
Magnate
Riverwild's Avatar
 
Join Date: May 2007
Location: Heah!
Posts: 2,921
15 yr Member
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OK, so some news posted in the past few days that is of interest to those of us on Tysabri:

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
http://www.fda.gov/NewsEvents/Newsro.../ucm288471.htm


Biogen and Elan win FDA Approval of label change for Tysabri
http://www.businessweek.com/news/201...r-tysabri.html


and a summary of Biogen's PML monthly update:
As of January 4, 2012, there have been 201 PML cases, of which 116 have been in the European Economic Area, 75 in the US and 10 in rest of world.
As of January 4, 2012, 42 of the 201 patients with PML have died.

As of January 4, 2012, in 47 natalizumab-treated MS patients who developed PML and in whom serum samples were available 6.5-187 months prior to the onset of PML, all 47 patients had anti-JCV antibodies detected.

As of January 4, 2012, samples were available from 74 patients at the time of PML diagnosis and all 74 tested positive for anti-JCV antibodies.
In addition, one sample, collected from a patient at the time of PML diagnosis following a cycle of plasma exchange tested negative for anti-JCV antibodies.

Because this sample was collected immediately following plasma exchange, and plasma exchange removes antibodies from the circulation, the information obtained from this sample is unreliable.

**One patient tested anti-JCV antibody positive two months before PML diagnosis. Previously, the patient had tested anti-JCV antibody negative 15 months prior to PML diagnosis, indicating that they had been exposed to the JC virus at some point between the two tests.

(** means even with a negative Stratify test, you should remain vigilant for any changes in affect, thinking, vision, weakness on one side or the other, etc. If you are unsure of the signs and symptoms of PML, please discuss them with your neurologist so you know what to look for. It is not known how people are exposed to the JC virus, and until they figure out how we are exposed, it remains a risk.)
__________________
I know the sound the river makes, by dawn, by night, by day. But can it stay me through tomorrows that find me far away?


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I have this mental picture in my mind of you all, shaking bones and bells and charms, muttering prayers and voodoo curses, dancing around in a circle of salt, with leetle glasses and tiny bottles of cheer in the middle...myyyyyy friends!

diagnosed 09/03/2004
scheduled to start Tysabri 03/05
Tysabri withdrawn from market 02/28/05
Copaxone 05/05-12/06
Tysabri returned to market 06/05/06
Found a new neuro 04/07
Tysabri 05/25/07-present
Medical Marijuana legally 12/03/09
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Negative for JC virus antibodies!
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I'm doing alright and making good grades,
The future's so bright, I gotta wear shades!
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