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FYI.


Begin forwarded message:

From: Dennis Mehiel <dmehiel@fourmco.com<mailto:dmehiel@fourmco.com>>
Date: April 11, 2016 at 11:46:38 AM EDT
To: "kevin@pattymurray.com<mailto:kevin@pattymurray.com>" <kevin@pattymurray.com<mailto:kevin@pattymurray.com>>
Cc: Anna Marie Cotter <acotter@fourmco.com<mailto:acotter@fourmco.com>>
Subject: Fwd: Contact Info

Hi Kevin,

Firstly, please thank the Senator again for her willingness to listen during our meeting this morning.

Secondly, In the interests of time I have copied you on the note that went to Chuck. As discussed, please forward to Patty and your Chief of Staff; we are hopeful you can arrange the meeting for the Company with your Health Care person in the next day or two. We can explain the time sensitivity when we meet.

Thanks for your help!

Dennis


Alex,

Thanks for taking the call. I wanted to double check all my facts, hence the delay. When we meet I will have a much more comprehensive report, but most of the key points are summarized below. This does not deal with the contemporaneous manipulation of the Stock itself, a separate subject and another avenue of attack that has killed more than one of our peers in recent years.

The firm in question is Northwest Biotherapeutics located in Bethesda, Maryland (NASDAQ: NWBO). A Phase three clinical trial of 348 Brain Cancer patients at 80 sites in the US, UK, Germany and Canada has been underway for about 8 years with enrollment 90% complete this past summer.

This past July the then Chair of the Independent Committee established to comply with the FDA Trial Protocol confected two or three different reasons why the trial should be halted and declared a failure. As each point was refuted by the Company as well as the Trial experience to date, a different reason would be advanced. Indeed, a large trove of protected data the Company is not allowed to have access to was bundled into an email and sent to the Company by the secretary of the Committee, who then resigned along with the Chairman. The data landed in the Company's Attorney's inbox and as a result did not get to the Company itself, which was fortunate as the unblinded data would have immediately killed the trial. During this period and after, the Chairman began to call the FDA as well as Regulators in the foreign jurisdictions to bring focus on the "Problems" with the trial. This former Committee Chair is also a decades long close friend of the new head of the FDA, who has been "Acting Head" during this period.

The FDA then instructed the Company to halt admissions and provide information to allow them to evaluate the progress and determine if the Trial can resume admitting new patients. The result of these actions by the FDA caused the Company to lose 85% of it's Market Value choking off Capital that is essential to the completion of the study. As you are aware, Development Stage Companies in the Bio Tech field typically have to raise hundreds of millions of dollars for many years without any ability to generate revenue. Regulators in the UK, Germany and Canada requested some information from the Company and upon receipt quickly advised that the Trial should continue.

Subsequent investigation revealed this former Chairman of the Committee to be the brother of a founder of a competitive Immunotherapy firm. We have now learned that the former Committee Chair is a Director of the Competitor, sits on it's Advisory Board and that they have in the past two years developed two vaccines that are identical to those we have been developing for close to 15 years. An IPO for this company is apparently in the planning stage.

For several months the FDA has continued to ask for more info and each time a request is satisfied we get a new series of questions. We felt these were unwarranted delays, but the Company complied. This was the period during which we were fearful of what would happen once the new FDA Head was confirmed by the Senate. It appears our fears were justified. The FDA has now responded and, among other things, advised the Company they will have to go back to the 315 or so patients already in the trial and get a new Consent Letter signed in which they are advised the treatment may turn out to be harmful. This was one of the key recommendations this Chairman advocated for with his FDA dialogue. In the years of activity, there is not a single adverse side effect or other case of negative impact on a patient. This is not surprising since the treatment does not introduce any foreign substance into a patient's body.

Interestingly, the data is now suggesting that although the mean survival rate for the treated patients is up about 60% from the Standard of Care outcomes in the population at large, the particular people in our study on Placebos have miraculously achieved the same exact improvement without treatment. Even with a substantial improvement, my understanding is if the companion group of patients on Placebo do as well as the treated patients the trial is by definition a failure. In a similar attack on another firm in this space, forensic investigation of Hard Drives revealed that the different treatment centers turned out to have been hacked with results adulterated. An example would be the fact that at eight different sites in that trial, the Placebo Mean Survival Rate was identical - a statistical impossibility.

We do not believe that career professionals at the FDA are involved in a plot to destroy Northwest and profit hugely from it's demise. But they do have to take direction from senior people and the tendency will always be to double and triple check every potential problem. That is as it should be, unless those protocols are manipulated to delay reinstatement of enrollment long enough to bankrupt the company. When we meet I can provide some recent examples of similar attacks and the results.

Obviously we believe we have major progress against a disease which is a short term death sentence for almost everyone that contracts it. However, we seek no special consideration or favorable treatment. We do want the science and the facts to prevail. Thanks!!


On Mar 27, 2016, at 12:01 PM, Katz, Alex (Schumer) <Alex_Katz@schumer.senate.gov<mailto:Alex_Katz@schumer.senate.gov>> wrote:

Good chatting just now, Dennis. Send over whatever you have, and talk tomorrow.

All my best,
Alex