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Re: Elvisdk post# 405596

Thursday, 09/30/2021 10:07:37 AM

Thursday, September 30, 2021 10:07:37 AM

Post# of 703622
Anyone saying that on Oct 6 Northwest has its first day of being too late to file trial results is wrong.

Standard submission deadline. In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.

The primary completion date on the DCVAX trial has come to past mid-august 2021 since it was mid-august 2020 and most probably weeks before that NWBO examined the last patient for the purposes of final collection of data for the primary outcome. In other words, Northwest is already legally late submitting trial results for weeks now.

Oct 5 has no legal meaning just a symbolic one

The video is wrong on several other points as well.



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