"The companies have been informed by the FDA that the Agency requires additional time to review information regarding the Tysabri risk management plan," Tysabri creators Biogen and Elan noted in a joint statement.

This is a not altogether surprising development and does not seem to jeopardize the return of the drug in any way. 90 days seems like a long time, but it is actually the minimum amount of time the FDA will grant for extensions in these cir*****stances-- in other words, they may not need the full amount of time. Furthermore, it seems quite ambitious in retrospect for a governmental agency to finalize a complex and critical risk management plan in the mere three weeks between the advisory committee meeting and the previous committed decision date of March-end.

In short, with this move the FDA has certainly delayed Tysabri''''s re-introduction to market, but this delay does not seem to be a point of concern in terms of the FDA preventing the drug from coming back altogether.

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