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beartrap12

05/28/19 11:38 AM

#229363 RE: reg2015 #229344

NWBO has run press releases before getting approval from all four countries. Germany was late, e.g., back in 2014. I think they would data lock and unblind with just the FDA. But I do think that if they plan to start manufacturing Direct again, that tells us they’re starting a new trial for Direct in 10 weeks, mid-July...which might just mean they expect datalock, or more, in L by then.

Kam8

05/28/19 12:17 PM

#229391 RE: reg2015 #229344

How long should take for Dcvax L be approved by 4 RAs after topline?