NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I agree hope4patients. I also believe that a $23 billion valuation is the floor for the value of the DCVax-L and the DCVax Direct vaccine platform, that has the potential to treat all or most solid tumor cancers, both operable and inoperable.

It probably will take several more years to validate and prove the efficacy of the DCVax platform to treat all or most solid tumor cancers. I know that every current NWBO investor will not have the patience or conviction to wait several more years for all of this to happen. Some current NWBO investors are content to sell their shares at $5, $10, $15, $20, etc. There is nothing wrong with that, and each of those sell levels does represent very good gains from NWBO’s current price of $1.25.

Every NWBO investor should make their own decision about when to sell their NWBO shares, based on their: time-horizon, risk profile, risk-tolerance, due diligence & research, cash needs, future expectations, etc.

But, I believe it is important to focus on the present and the future. I believe that starting in 2022, we will see the following become reality:

DCVax-L will be approved to treat newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM), in the US, UK, Canada, Germany and the rest of the EU.

Then, also in 2022, I believe we will see NWBio (or the BP that acquires NWBio) initiate an Investigational New Drug application (IND) with the FDA for both DCVax-L and DCVax Direct. I believe these 2 INDs will help start a Phase II/III clinical trial to confirm the safety and efficacy, and establish both DCVax-L (operable solid tumor cancers) and DCVax Direct (inoperable solid tumor cancers) as personalized immuno-oncology and immunotherapy platforms to treat all or most solid tumor cancers.

I also believe each of these Phase II/III clinical trials for DCVax-L and DCVax Direct will be a “Basket Trial” with a Master Protocol design, and will simultaneously evaluate multiple solid tumor cancer types ( such as: lung, stomach, colon, breast, testicular, ovarian, prostate, uterine, pancreas, bladder, etc.) in one trial. This will greatly accelerate how long it will take for both DCVax-L and DCVax Direct to be approved as platform immunological vaccines to treat all or most solid tumor cancers.

I believe that each of these clinical trials for DCVax-L and DCVax Direct will be based on the guidance issued by the FDA, where the single investigational biologic is DCVax-L with or without a PD-1 inhibitor in 1 basket trial, and DCVax Direct with or without a PD-1 inhibitor in the other basket trial. Then, the Disease Type (D1, D2, D3, D4, D5, etc.) will be different solid tumor cancers (Lung, Prostate, Colon, Breast, Pancreas, etc.) .





https://www.fda.gov/media/125556/download

This is similar to the Istari Oncology basket trial for solid tumor cancers, using PVSRIPO with or without a PD-1 inhibitor. It is also similar to the CytoDyn Phase II basket trial evaluating the safety and efficacy of Leronlimab in treating 22 different types of solid tumor cancers, including: melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, etc.:

https://finance.yahoo.com/news/istari-oncology-announces-fda-clearance-120300015.html

https://www.cytodyn.com/newsroom/press-releases/detail/416/cytodyns-phase-2-basket-trial-for-22-solid-cancer-tumors