NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Time and again, we have seen that this management is not proactive and lack the experience and foresight.

That's funny. To me it seems as if they predicted the following:

1) Let's use UK as a base for building infrastructure, production, manufactoring, the compassionate use program because something tells us, that DCVax-L could disrupt BP's cancer market to a degree, where we could meet rough resistance by BP, hedges, news medias, big pharma and maybe FDA, making it harder for us to finish the trial and get approved.

2) Let's extend the trial, because we risk FDA won't approve DCvax-L even though we have excellent data, because we are not able to supply demand with the current DCVax-L manufactoring method.

3) So ...let's buy Flaskworks and develop their technology to be able to automate and scale the production of DCvax-L and then we can also gather more data to the tail of year long survivors.

4) The PFS endpoint doesn't work with immunology, because of pseudoprogression. It is an initial flare-up of the tumor after immunotherapy, which may change to a more favorable response. We need to be sure, that FDA agrees on that.

5) We need to get FDA on the wagon regarding the use of crossover trial design, which was necessary for feasibility and ethical reasons: Necessary for enrollment and retention of patients in era when immune therapies not yet generally viewed as promising for cancer Important to justify all patients undergoing invasive leukapheresis procedure. No benefit to placebo patients unless they could receive their autologous product made from the leukapheresis. There's a necessity to differentiate between crossover patients and originally DCVax-L randomized patients, which is why the new secondary endpoint was introduced. OS endpoints could not be within-study comparisons of DCVax-L patients vs. placebo patients, because placebo patients received DCVax-L following crossover. So, the OS endpoints compared DCVax-L patients with external controls. This approach fits well with growing commentary in support of streamlined trial designs and use of external controls where classic within-study comparisons are not feasible.

This is why external controls were used; because internal controls, the actual patients, found DCVax-L so good that they went for it en masse. (excerpts of text from Seeking Alpha article)

So ... there it was. An article from FDA by 13 FDA employees including Pazdur, that greenlit the use of ECA.

6) Let's keep NWBO slim and "buyout'able" and move the CDMO part over into an external entity Advent Bioservices, that could exist both after an eventual BO, but also as a separate entity, if a suitor wouldn't want that "to go". We've learned from Dendreon.

So yeah, to me it is funny to insinuate the management is not proactive and lack the experience and foresight.

To me it seems as if they've predicted a lot of the ordeals, that shorters believed would sink the trial and that made them able to maneouver around all these obstacles and bring it home to data lock.

Then they went quiet because they predicted "opposition" to hit them hard when they "spoke", as they've been countless times by Adam Feuerstein and several fraudulent lawsuits, that was only meant to delay them and diverting resources and spend time and effort to slow down progress.

That gave us patents, certifications, scaling, automation, Flaskworks, +60 hired at state of the art facilities to begin commercizlization and going for approval in the UK to maximize pressure on FDA.

I have never seen a company lacking experience, manage their ship so professional.

The foresight and proactiveness has been second to none.