Replies to post #596536 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

Ex,

Simply put this way. If DCVax-L + Poly-ICLC + Keytruda + CSF1R-I works for several types of soild tumors, tumor-agnostic rule applies.

It is just this simple.

[Dr Bala]

Total nonsense. Confusion in the post. Futile to argue against the best ever JAMA GBM data.

[Dr Bala]

A totally misguided post. Misapprehension and misunderstanding in the post of even basic science related to GBM are evidenced by the nonsensical material in the post.

[sentiment_stocks]

LL has indicated that DCVax-L works well with mesenchymal tumors. Could a mesenchymal designation be a type of biomarker?

[biosectinvestor]

It targets any and all specific biomarker alterations. You appear to be confused by the flexibility of the platform. That is exactly what it targets, biomarker alterations from the patient’s normal cells, by their immune system governance system. It is the ultimate exact treatment that fits this definition.

[georgebailey]

Severe misunderstanding entirely.

[dennisdave]

Besides, the guidance, like others, specifically states that OS is compared to ECAs is not a valid endpoint.

The FDA has never said that, thats a blunt falsehood. Its not for nothing that you never quote FDA regulations with a link. Why is that?

[dennisdave]

Confirmatory evidence could include, for example, adequate and well-controlled clinical
investigations in a related disease area, certain types of real world evidence20

Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.

Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.


https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence