Dendreon construction poses approval timing questions (DNDN)
June 23, 2009 · Filed Under General
Dendreon (DNDN) shares are weak this morning as market participants appear to be questioning whether the company’s key Provenge drug can be approved before there’s a plant buildout.
Late yesterday, biohealthinvestor.com noted that the company has contracted to build a manufacturing plant in New Jersey. See previous post for full details.
What appears to be happening now is that some are questioning whether FDA approval for Provenge will happen after the fourth quarter of 2009, when the second phase of the construction is scheduled to be completed.
If that happens, the drug would be considered late to market. Analysts have been expecting Provenge to be approved by the iddle of 2010. — Mike Tarsala
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