Replies to post #394492 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

anders the one-year FDA disclosure period has not expired as the final data was obtained on October 5. I don’t recall thermo’s turn of phrase but I am confident of this statement. Also, and I am not aware of the specifics, other informed persons on this Board opine that this rule is subject to exceptions and/or interpretation. I express no opinion on that view.

Uhm, first the rule does not apply if the company asserts they are planning on filing a BLA for a previously unapproved product.

Second, the clock starts with the last data collection from a patient, not the data lock. We do not know when that was, but certainly well over a year ago.

Third, this is the same body of law that LP has violated for years. There is basically no enforcement.

OH, and one just for fun. It does not apply if the primary completion date was pre Jan 17, 2017. And what exactly does the US trial registry state on that subject?

[anders2211]

I have to agree with ex on this:

Second, the clock starts with the last data collection from a patient, not the data lock. We do not know when that was, but certainly well over a year ago.

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.

Source: https://www.law.cornell.edu/cfr/text/42/11.44#b_1

Then what is the primary completion date well:

The final rule in 42 CFR 11.10(a) defines "[primary] completion date" for a clinical trial as the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated"
source: https://clinicaltrials.gov/ct2/manage-recs/faq

so the question is thus when was the primary completion date that the last DCVAX L patient was examined or received an intervention for the purposes of final collection of data for the primary outcome? I dont think that was on Oct 4th, 2020 but around well now...

But I agree with ex we don't know that for sure