Dendreon CEO Mitchell Gold has had two years to study the FDA's rejection of Provenge back in 2007. Over that period Dendreon has patiently pieced together a positive set of new data supporting the prostate cancer vax. And Gold just doesn't believe that regulators can deny Dendreon once again.
"I think the regulatory risk for Provenge is low at this time," Gold told a healthcare conference. And he added that Dendreon is on track to file for an approval in the fourth quarter.
Dendreon shares tripled in the days after April 14, when the company released data showing that Provenge significantly improved the three-year survival rate of prostate cancer patients. There's still no word on how Provenge would be priced, but Gold put it in the same ballpark as other cancer biologics--which will likely translate as very, very high. He added that word of the therapy has already spread widely among cancer docs.
- read the report [1] from Reuters
Related Articles:
Is Dendreon a likely takeover target? [2]
Dendreon shares bounce on late-stage Provenge data [3]
Dendreon beefs up pipeline work with oral cancer drug [4]
Dendreon reveals Provenge data at AARC meeting [5]
Links:
[1] http://uk.reuters.com/article/marketsNewsUS/idUKN1231356620090512?pageNumber=2
[2] http://www.fiercebiotech.com/story/dendreon-likely-takeover-target/2009-04-30
[3] http://www.fiercebiotech.com/story/dendreon-shares-bounce-late-stage-provenge-data/2009-04-29
[4] http://www.fiercebiotech.com/story/provenge-beefs-pipeline-work-oral-cancer-drug/2009-04-21
[5] http://www.fiercebiotech.com/story/dendreon-reveals-provenge-data-aarc-meeting/2009-04-20