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Re: longusa post# 3236

Tuesday, 01/07/2014 2:57:31 PM

Tuesday, January 07, 2014 2:57:31 PM

Post# of 700532
Long,

The NDA filing for 2nd generation DCVax-L under your proposed timeline is why I think our congress needs to look at updating their stem cell and immunotherapy dendritic cell (autologous) approval legislation. Japan has done this, and the procedure you propose -- including a mandatory post market confirmation study -- would be allowed. IMHO. If things go well for the current versions of DCVax-L and Direct, I hope NWBO does not have to go to Japan first to get early approval for 2nd generation L.
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