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Magnate
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Natalie,
You mentioned that you felt that Biogen should have sent something out after the PML cases were reported. They had conferences for the neurologists who are prescribing Tysabri and in most cases the doctors then take the information gained from those conferences back and share them with the patients. I doubt they have had one yet for the US PML patient yet, it just happened. The two patients this summer were conferenced, my doc was on the first conference call and that was two weeks after the report. Biogen has stated that they will no longer be reporting PML cases the way they have in the past. They reported the EU cases because they were the first since return to market. They reported on the US case because the SEC required them to file an adverse event report (8K) with the SEC because it could affect the value of shares, and it was the first US patient since the return to market. They will be leaving it to the doctors to file adverse event reports with the FDA, since the labeling already reports the rate of 1:1000 chance of PML, and the rate so far is well below that. It will be interesting to see what actually comes from investigation of these patients and their drug histories.
__________________
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? . 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 diagnosed 09/03/2004 scheduled to start Tysabri 03/05 Tysabri withdrawn from market 02/28/05 Copaxone 05/05-12/06 Tysabri returned to market 06/05/06 Found a new neuro 04/07 Tysabri 05/25/07-present Medical Marijuana legally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 . Negative for JC virus antibodies! . I'm doing alright and making good grades, The future's so bright, I gotta wear shades! . |
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