Replies to post #3733 on Dendreon Corp fka DNDNQ

[invest in kids]

>> An approvable letter that requires the results from another clinical trial for the FDA to reconsider the application is a euphemism for a rejection. <<

According to section C in

http://www.fda.gov/cdrh/mdufma/guidance/1218.html#_Toc47768482

that would require a Major Deficiency Letter, would it not? Section B (Approvable Letter) states minor deficiencies.