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ATLnsider

12/15/20 8:59 AM

#339263 RE: Maverick0408 #339244

I think that Dr. Linda Liau was reflecting retrospectively about the entire process & experiences with the DCVax-L Phase III trial, and their interactions & experiences with the FDA from 2007 to 2020. For decades, the FDA has insisted on & preferred that Sponsors conduct a randomized control trial (RCT), preferably placebo controlled & blinded. This has been, and still is, the gold standard.

The FDA (and the other RAs worldwide) did not really prefer to even offer a crossover option to patients, even in a trial with a deadly disease and the OS outcome (14 to 16 months OS for GBM) was well-studied & well-documented in other historical RCTs.

However, the FDA has evolved on this issue, and they are now the biggest proponent of using RWD & RWE. The FDA has come to realize that it is not humane or moral to ask patients who are facing a deadly disease, with unmet needs & very few effective treatment options, to continue to enter blinded placebo controlled trials, if the SOC treatment OS outcome is already known. Here is some more FDA guidance on using external contemporaneous historical control groups:

ATLnsider

12/15/20 9:16 AM

#339270 RE: Maverick0408 #339244

Maverick0408, in regards to why NWBio has not updated the clinical trials.org website, take a look at my previous message post:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160183071

TiltMyBrain

12/15/20 9:32 AM

#339277 RE: Maverick0408 #339244

Didn’t they hire a IT guy a while back???