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Re: biosectinvestor post# 438016

Tuesday, 01/25/2022 8:45:54 AM

Tuesday, January 25, 2022 8:45:54 AM

Post# of 704164
Biosect, I believe that you and I are of like minds when it comes to appplying this SEC rule to biopharma companies. Although there is a nuance that I may come back to ask you about.

I am interested in your views on a tangent from the current discussion. Shorts state a belief that an IA was performed and they know the trial has failed, but continue to perpetuate a scam. This actually forms the basis of most short-side theory. This, however, cannot have happened, and forget SEC.

For this to have happened, it would have occurred before the August 2015 halt in new screening and here is where that argument falls apart. Investigators brochures must contain updated safety and lack of efficacy data. Evidence of lack of efficacy would require patient consents be updated which requires IRB approval. These policies are governed by regulators and are in accordance with Geneva Convention international law. If they had knowledge that the data showed lack of efficacy, then patients in screening would not have been put on drug prior to the changes being implemented and IRB approved. Same is true for any patient currently receiving active drug post-randomization. On top of that FDA lifted the halt in 2019, and a new trial involving all patients receiving DCVax with or without a combined previously failed therapy. Meanwhile LL promotes this trial to her colleagues and accepts referral patients.

These are human clinical trials regulated by all 4 governments and not some experiment on rats in a lab.
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