NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

Some of your statement below
"
I clearly meant that a patient most probably died in the Ph III trial, recently (perhaps in July), and it spurred an investigation. I think it may have occurred in Germany as they seemed the quickest to respond by issuing a temporary halt on their CT version.

There are very few reasons why a temporary halt occurs, and even fewer as to why it occurs in pivotal trials. A temporary halt never occurs to file AA or enter dialogue with regulators as to whether or not it is advisable to halt the study and begin that process. The trial simply remains ongoing or fully and permanently halts for that. FDA will give general advice in these circumstances but will refuse to even examine any efficacy data so that if they have to make a later decision they can do so in an unbiased manner.

A temporary halt of a pivotal trial, especially if this far along in events and enrollment, is almost always going to be due to a safety concern. Initiated by DMC, who will submit all data on the patient who died (probably of encephalitis in this case) along with all safety data from the trial. That takes some time to assemble. It's not a clinical hold, yet, but the steps before one might be issued. Yes, it's a real possibility here, but most likely regulators will examine data and declare the therapy safe to continue. When, you ask? Who knows? Probably they will submit the rest of data in another week or two and then receive a response within 3 months would be my guess."

I remember I took an exception to reply to your endless posts of your belief there is safety issue going on in P3 DCVax-L trial. I hate to see there are still posters reply to your not innocent FUD. So I am going to post it again below:

"
Dan88 Tuesday, 08/25/15 12:39:30 PM
Re: Pyrrhonian post# 39286
Post # of 39735
Just back from my long vacation and a quick trip to Southern China thereafter.

Seen so many posters have replied to your endless FUD, I am going to take this exception to reply to your post (no further replies shall be expected):

If it is due to safety issue, the company would not only stop screening patients, it would have to stop recruiting and treating any patients (existing and potential). See example below:

" Oncothyreon announces temporary suspension of Stimuvax clinical trials by Merck Serono

SEATTLE, March 23, 2010 /PRNewswire via COMTEX News Network/ -- ONCOTHYREON TO HOLD TELECONFERENCE AT 5:00 PM EDT

Oncothyreon Inc. (Nasdaq: ONTY) today announced that Merck Serono, a division of Merck KGaA of Darmstadt, Germany, and its U.S. affiliate, EMD Serono, Inc., have temporarily suspended the worldwide clinical development program for Stimuvax(R) (BLP25 liposomal vaccine). The suspension is the result of a suspected unexpected serious adverse reaction in a patient with multiple myeloma participating in an exploratory clinical trial. This decision was taken in alignment with the U.S. Food and Drug Administration's (FDA) clinical hold placed on the Investigational New Drug (IND) application for Stimuvax.

The suspension affects the Phase 3 clinical program for Stimuvax, including the START and INSPIRE trials in non-small cell lung cancer (NSCLC) and the STRIDE trial in breast cancer. Further recruitment of patients into all trials actively recruiting patients and ongoing treatment with Stimuvax in these trials are suspended.

"Patient safety is of paramount importance to Merck Serono and to Oncothyreon," said Robert L. Kirkman, M.D., President and CEO of Oncothyreon. "We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient's physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action."

The exploratory trial in multiple myeloma is designed to investigate the mechanism of action of Stimuvax and the effect of cyclophosphamide on regulatory T cells, which may affect the response to the therapeutic vaccine. The adverse event occurred in a patient receiving a more intensive regimen of low-dose cyclophosphamide than is utilized in the Phase 3 program. The patient developed an encephalitis, or inflammation of the brain. No other events of this kind have been reported in other trials of Stimuvax to date.

Conference Call Information

Oncothyreon will host a conference call and webcast today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. To participate in the call by telephone, please dial 877-280-7291 (United States) or 707-287-9361 (International). In addition, the call is being webcast live and can be accessed on the "Events" page of the "News & Events" section of the Company's Web site at www.oncothyreon.com. An archive of the webcast will be available after completion of the discussion and will be posted on the Oncothyreon website.

About Stimuvax

Merck KGaA has an exclusive world-wide license from Oncothyreon for Stimuvax. Merck KGaA is investigating the use of Stimuvax(R) (BLP25 liposome vaccine) in the treatment of NSCLC. The vaccine was granted fast-track status in September 2004 by the FDA. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Inc.

START is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study that will evaluate patients with documented unresectable stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study will involve more than 1,300 patients in approximately 30 countries.

The INSPIRE study is a multi-national, Phase 3, double-blind, placebo-controlled, randomized clinical trial designed to evaluate the efficacy, safety and tolerability of Stimuvax in subjects suffering from unresectable, stage III NSCLC and demonstrating either stable disease or objective response following primary chemo-radiotherapy. The study will enroll approximately 420 unresectable, stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

STRIDE is a randomized, double-blind, controlled, multi-center Phase III study designed to determine if Stimuvax(R) can extend progression free survival in patients treated with hormonal therapy who have inoperable, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study."

The link is here: http://ir.oncothyreon.com/releasedetail.cfm?releaseid=453976

I keep adding shares and options since this drop. Today I also add 20 2017 target $10 call contracts at $2.15 a piece.

I will continually urge people not to reply to your posts, since you are a person proven not trustworthy (moderator it's my genuine opinion, please not think it is a personal attack and name calling. Thank you).

Too busy, not time to post further, and life is beautiful, not intend to waste my time in thing like this."

And I summarize in my next post:

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Dan88 Tuesday, 08/25/15 12:47:42 PM
Re: Dan88 post# 39308
Post # of 39735
BTW, I went through that whole process with your IV friend in 2011. All patients in the trials not only the one in which the safety issue occurred but all trials using the same vaccine called Stimuvax at the time were stopped of any further treatment with the vaccine.

Above is just additional information for those who are so busy to sort through the news I provided."