I seem to remember reading that FDA approval hinges on demonstrating process/intent/ability to mass manufacture. So...I'm thinking that's already underway.
But (always the but)..as I see with Provenge, FDA approval doesn't mean insurance is ready to deal with it. Medicare is still assessing coverage issues post FDA approval.
Private payers mull restrictions on Provenge[IMG]chrome://searchshield/content/safe.gif[/IMG]
FiercePharma -
Tracy Staton - 2 hours ago
How are insurers likely to treat Dendreon's (NASDAQ: DNDN) new prostate cancer vaccine
Provenge? Very carefully, at least according to a new survey from
...
Dendreon (DNDN) 17% 4-Day Jump Raises Eyebrows; Is a Deal in the ... - StreetInsider.com (subscription) (blog)
all 2 news articles »Dendreon Falls As Govt Starts Provenge Analysis[IMG]chrome://searchshield/content/safe.gif[/IMG][IMG]chrome://searchshield/content/vrsn-secured-lsfo.gif[/IMG]
Wall Street Journal -
George Stahl - Jun 30, 2010
The answer to that debate--the latest hurdle in Dendreon's push to get
Provenge used--will affect sales of the costly treatment. If the Centers for Medicare
...
Dendreon: Medicare reviewing Provenge coverage - The Associated Press
Why is Medicare Reviewing Dendreon's Provenge? - Forbes (blog)
Medicare looking at Dendreon cancer vaccine - Re
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