NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

The U.S. FDA is not the only RA that will approve murcidencel—remember that RAs worldwide will have the opportunity to offer their support to this novel cell-based technology.

The FDA approved the trial to commence. The FDA approved the P1 to advance to P2, then the FDA approved the P2 to advance to P3.




Further, the ICLC murcidencel study has been ongoing for over a decade. Additionally, the FDA approved the Keytruda P1 to proceed which has produced interim survival data.

Data collected from ECA comparison only comprises a fraction of the clinical efficacy data that exists for murcidencel today.

Murcidencel has been studied in three trials—only one of those three relied on an ECA. All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All three trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

Furthermore, the NIH has supported Liau’s murcidencel cell-based technology and is funding the Keytruda combo clinical investigation today.





https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/

https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter





https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847