On Friday, two major drugmakers got the wrong end of the Food and Drug Administration's wishbone for drug applications. Both plan to resubmit their applications for approval in the first half of next year, but the delays likely will have different effects on the companies.
First, the FDA sent AstraZeneca
The delay shouldn't hurt AstraZeneca much because motavizumab likely will just replace sales of Synagis, its current RSV treatment. AstraZeneca eventually needs to get the more-effective motavizumab approved to compete with up-and-coming drugs like Alnylam Pharmaceuticals'
Second, Eli Lilly
Sales of Cymbalta have trounced other depression drugs like Pfizer's
When investors value label expansions or drugs in a company's pipeline, they need to factor in the possibility of a delay -- especially in this regulatory environment. More importantly, you've got to know how much a delay is going to hurt the company if the drug isn't approved on its first go-round.
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