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06-14-2010, 08:56 AM
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Magnate
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Thanks for posting this Natalie!
The FDA usually follows the recommendation of the advisory committee, but not always. There are a lot of safety concerns with this drug, but the advisory committee voted to approve because with monitoring, they feel the benefits will outweigh the risks shown in study information. The FDA may require a trial for an 0.25 mg dose to be run to see if a lower dose is less risky, if they approve the 0.5 mg dose. It's thought that they may require a program similar to "Touch" for approval. Hopefully no weird stuff pops up after approval!! It looks like orals may actually be here! 
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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 diagnosed 09/03/2004 scheduled to start Tysabri 03/05 Tysabri withdrawn from market 02/28/05 Copaxone 05/05-12/06 Tysabri returned to market 06/05/06 Found a new neuro 04/07 Tysabri 05/25/07-present Medical Marijuana legally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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