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Re: hyperopia post# 368547

Wednesday, 06/02/2021 8:37:44 PM

Wednesday, June 02, 2021 8:37:44 PM

Post# of 723878
Stumbled onto the company assembling the synthetic control am (SCA), or rather, a "hybrid external control" for that Medicenna Therapeutics rGBM trial given FDA permission that you'd referenced in your post: Medidata, and their Acorn AI. I thought I'd make mention of it here, although you likely know this.

Hybrid external control: combines synthetic control arm patients with randomized patients. Our discussion evolved from LL's slide for the ECA which showed pulling patients from the randomized trial (and I'd wondered if they intended to use the 30 or so randomized DCVax-L P3 patients that never crossed over), and then build the ECA from there using other historical control patients.

Medidata synthetic control arm lands FDA approval for cancer trial
https://www.outsourcing-pharma.com/Article/2020/11/19/Synthetic-control-arm-lands-FDA-approval-for-cancer-trial

Medidata has helped sponsors run clinical trials for over 20 years, accumulating a clinical trial data repository of 6 million+ patients and 22,000+ trials. This unique data asset enables distinct bene ts over traditional real world data sources.
https://www.medidata.com/wp-content/uploads/2020/11/Acorn-AI-Synthetic-Control-Arm-Fact-Sheet-3.pdf

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