Macro Tsimmis

intelligently hedged investment

Élan (ELN) update #4

Posted by intelledgement on Mon, 15 Oct 07

Élan (ELN) and Biogen Idec (BIIB) jointly announced today that the FDA have informed them that regulators have decided to take up to another three months to review the companies’ application to market Tysabri to Crohn’s disease (CD) patients in the USA. According to the press release, “The companies have been informed by the FDA that the Agency requires additional time to review information regarding the proposed TYSABRI risk management plan for Crohn’s disease. Under this revised timeline, the companies anticipate action from FDA on or before January 13, 2008.”

Despite the 12-3 endorsement of the companies’s application by the FDA’s advisory committee in July, The Street had apparently been anticipating an FDA rejection in the wake of the rejection of a similar application by EU regulators, also in July. However, this delay is an indication that the application is being taken seriously and apparently the market calculus has shifted in favor of eventual approval, as ELN closed up 8% today on heavy volume.

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