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biosectinvestor

01/27/22 12:58 PM

#439205 RE: eagle8 #439194

Thanks Eagle. Interesting, though the EMA official website still says what it said, even though the trial clearly continued to completion minus the rest of the placebo patients. I think that is a hint from the time though that all was not exactly what it seemed as they were saying patients are still getting the drug, etc.

I think there was much confusion as to what and how to communicate exactly what was occurring. I think they were trying to explain, but it was just not easy to explain and by the time I came along everyone had settled on the description that it was a partial halt. I came along after that PR. I have monitored NWBO since 2008, but not closely at that time.

I think it just speaks to the confusion of the explanation of what was really going on, who was listing what and would or would not ultimately change their listing.

EudraCT Number: 2011-001977-13
Sponsor's Protocol Code Number: 020221
National Competent Authority: Germany - PEI
Clinical Trial Type: EEA CTA
Trial Status: Temporarily Halted
Date on which this record was first entered in the EudraCT database: 2013-02-11
Trial results



I also thought we determined that the company does not update or change that site, the regulator does.
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ATLnsider

01/27/22 1:07 PM

#439209 RE: eagle8 #439194

thanks eagle8, I also think that the words directly from NWBio, on page 14 of its 2018 10-K, provides a direct clue of what happened:

In addition, our Phase III trial of DCVax-L was placed on a partial clinical hold for new screening for enrollment in 2015. Although the FDA lifted its hold in February 2017 as previously reported by the Company, the Company had already closed enrollment with 331 of the planned 348 patients.


https://www.sec.gov/Archives/edgar/data/1072379/000114420419017803/tv517288_10k.htm