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vator

01/28/15 4:16 PM

#28731 RE: gnawkz #28729

Baloney! "L" is still a great product for all operable rumors. It will just take longer than Direct for approval here in the US.

"L" still has HE and PIM. I am sure the manufacturing facilities will handle Direct as well as "L" but "L" acceptance in Germany and the UK has pushed the product entry there.
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longusa

01/28/15 4:49 PM

#28733 RE: gnawkz #28729

Gnawkz, DCVax-Direct may receive AA, with either PhI or PhII data, before DCVax-L gets to a PDUFA date. That is one of the imports of my previous post on the topic today.

Given that it would likely be the case that DCVax-Direct would have a larger label (larger market available) than DCVax-L at any given point in time due to i) a much more rapid protocol for label expansion trials, and ii) initial label in cancers with larger markets, if the unlikely outcome of DCVax-L failure and DCVax-Direct success occurs, NW (IMO) would still be immensely successful.