NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

A few thoughts. These are just my opinions, as usual, and should only be given the weight of an opinion. None of us know exactly what is going on internally with the Company, though we can guess at certain things based on a variety of factors. That's all I am/ have been doing:

German sites. Back in August a PR said:

The Company has obtained approval from the US FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and conditional approval from the German regulatory authority (the Paul Ehrlich Institute, or PEI). The Company is now working toward the final approval from the PEI.

It was primarily an increase in trial size and additional analyses of low CD4+ patients at the end of the trial. Conditional approval for all intents and purposes is present approval, conditional on future requisites. In other words, they increased N in German clinical trials registry but it is conditional to NWBO submitting whatever documentation is required of them to obtain full approval of the changes. Conditional approval of these changes is important and should not be overlooked, and enables the process to move forward undeterred.

The following was written in the midst of all of these clinicaltrials updates anyway (we were just PRed after the fact):

BETHESDA, Md., June 10, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has initiated the Phase III trial of DCVax-L in Germany. The first site to open in Germany was a medical center in Dresden, which was initiated in late May. The Company has now scheduled the full-day site initiations for 3 more sites during June and 4 further sites in July...

...The fourth [and final] step is the “Site Initiation.” This involves arranging and conducting a full-day, detailed, joint training of all of the personnel who will be involved in the trial: e.g., the neurosurgeons, neuro-oncologists, head of the hospital’s pharmacy, pathologists, radiologists, nurses and others. The lead time for arranging this joint training with so many players on the same day is typically substantial. The training includes all aspects of the trial, including the patient eligibility criteria and procedures, treatment procedures, testing and monitoring procedures, data collection, etc.

All told, there is no reason to think anything has stalled out in Germany. Signals suggest aggressive advancement of programs there (although a much prolonged initial set-up compared to the US, and one which has been ongoing since 2012--in particular as regards the HE program).

Cognate:

I basically keep saying the same thing--manufacturing for a Ph III trial is exponentially (literally) cheaper than utilizing a manufacturer to ramp up towards commercialization. Cognate is not just making vaccine. This process takes new facilities (or massive expansion of existing ones), additional staff, more equipment, implementation of automation, jumping numerous regulatory hurdles, and exclusivity--meaning DCVax will take up all/most of Cognate's time. Comparing this to mere vaccine manufacturing for 300 patients spread out over 3-4 years is hardly an accurate comparison.

As an example:

Argos Therapeutics, Inc.(Nasdaq:ARGS) ("Argos"), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis ® technology platform, broke ground on a new 100,000 square foot biomanufacturing facility in the Research Triangle Park area in Durham, North Carolina. The facility may lead to more than 230 new jobs and will include advanced equipment for automated manufacturing of Arcelis-based products.

In other filings they are spending somewhere between $20mm-$30mm on the above.

If you examine the costs a manufacturing facility charges for producing tx for a trial they are far, far lower than what they charge for commercialization of the product. This should be obvious, but.. Anyway, here is PCT's breakdown:

PHASE 3 CLINICAL TRIAL MANUFACTURING CONTRACT:

200 to 400 Units Produced:

$3,000,000 to $6,000,000

COMMERCIAL MANUFACTURING CONTRACT:

2,500 to 5,000 Units

$38M to $75M / Yr.

What Cognate is doing and spending on is for the latter of the above two. They already expanded capacity in the US just for DCVax to be able to produce 5,000 vaccines a year (50,000 sq.ft. facility expanded from 35,000). Is that supposed to be free? They are currently doing the same in the EU.

All of these comparisons between what's going to Cognate and what is normally spent on Ph III vaccine or drug manufacturing is completely amiss. But until Gross sales - COGS = $$$ on a 10-Q, there will be plenty of FUD to feast on.

Lastly, business is popping for me and I just landed two nice and rather large contracts and will have to do some expanding of my own, so I won't be the posting and article writing machine I once was. But I do plan on writing an article after reimbursement negotiations have finalized and a few more down the road when other major catalysts occur. Obviously I'll still post here, but the frequency going forward will be far less. So just a heads up that I'm still invested and very bullish NWBO (obviously, lol). GLTA non-shorts ;)