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Originally Posted by retired_at_40_01
I am now registered on this board as well as "this is MS" board. Whatever works. That's all I'm trying to say. We all have to take a risk doing something.
Laying back because somebody said X might happen is for the birds. As you can tell, I'm very proactive. Do something as long as it is not to harmful. The FDA is and has to be VERY conservative. Tysabri did not have to beg to be put back on the market. The #'s spoke and low and behold, it has worked for some. Isin't 1 worth it?
Pete
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Biogen indeed did have to "beg" to get Tysabri back on to the market. The FDA held public hearings and invited MS patients to speak at these hearings. That is rarely done. They also pushed up the time frame by 4 months for the appeal process. There was a lot going on in the background with Tysabri and the huge amount of money at issue with its re-approval certainly didn't slow things up.
The biggest problem Tysabri had and still has is the fact that nobody knows the correlation between it and possibility of contracting PML. And when the docs can't tell the FDA, the FDA gets twitchy!
Harry