Replies to post #546989 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

As your mom had a second resection -- did she complete the trial? It confounds the OS data.

Let's stick with bullshiting investors instead of spreading bullshit to actual patients. Can't go any lower than that.

Have a great one gro.

[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

[dstock07734]

HyGro,

You do know that Padur's paper was referred in the JAMA paper.
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext

Since you always conjecture that FDA will not grant approval on murcidencel, is it reasonable for us longs to think once that JAMA was postponed for such a long time simply waiting for FDA to finish the regulatory preparation?

You are right that FDA will review a lot more data than reviewers of the paper. You do remember the expansion program of dcvax for compassionate use. FDA for sure will have plenty data for many individual cases. IMHO, the conclusion from these data can be only be good.

https://clinicaltrials.gov/ct2/show/NCT02146066