Replies to post #36217 on NorthWest Biotherapeutics Inc (NWBO)

[TC_Trader]

Welcome back, Pyrr!

[flipper44]

I did not find the link helpful but thank you for providing it. What I found helpful was looking at other studies in immunotherapy regarding early disease control. Particularly the long term follow up on Yervoy (which has been around for quite sometime.) They learned that early stable disease was more important than previously suspected in relationship to overall survival.

The challenges regarding tumor enlargement via pseudo progression are mentioned in Dr. Bosch's speech.

•Tumors can appear larger due to infiltration of inflammatory cells and/or immune cells
• Tumors can appear larger due to accumulation of fluids
• Tumors can appear to maintain size, despite extensive necrosis

This will make an excellent phase II trial design critical.

And yes, I find the statistic impressive that 86% of patients on method B achieved S.D. within 8 weeks, that is as yet unprecedented in my review of immunotherapy literature. 100% of those patients continue to currently survive (approximately 9-15 months thus far.)

The further granularity you're looking for sounds like someone I know, and I'm afraid you'll have to wait like him and all the rest of us until tumor response data has matured, the last four patients are further processed, and that information is revealed. Your lack of trust in management also reminds me of that person. You should have tea. The fact that at approximately 9-15 months none (aka: 0%) of the 16 patients have passed away suggests S.D. achieved by 8 weeks was maintained through the 6 month filter you discussed.

To state further Disease control data and ORR data is not understood by me from the statement I made is illogical. Again, you'll have to wait and see what further matured data provides. Recist 1.1 is one of the measures they are looking at to determine if it can be used as a useful prognostic tool in the phase II trials. I anticipate we will see ORR data (P.R. and perhaps C.R.) when Dr. Bosch gives us the next update on DCVax-Direct phase I. You need to look at the sarcoma patient with 5 lesions whose tumors all grew before shrinking to comprehend what I am talking about. Its slide 15 in one of LP's prior presentations.

So you see, you are inventing misunderstandings that I supposedly have as a straw man argument to buttress your skepticism. It's a debate technique that someone I know is quite deft at.

Still, you will have to wait like all the rest of us for more granularity. It makes sense for the company to wait to give tumor response data because PR and CR typically occur later than stable disease in immunotherapy.

[TZOR]

Well Mich because you have never heard of one, then obviously it cannot exist. That is the premise of your argument from line one. I look forward to more data from NWBO, do you?

[Know-Fear]

As long as supposition is in play. What if NWBO has a proprietary manufacting process that makes never before seen attributes and maturation method B attainable?

[beachlifeisfun]

Hi "Michonne"

It is pretty tough to refute 100% survival of the -B treatment when taken in light of post 35897, who has a firsthand perspective:

A word of advice.

I do read many of the comments over at Investor Village and this guy jmlogan is a real piece of work. Apparently he has the extreme confidence in his theories despite most of them being based on fantasy. Being part of this trial, I would never even attempt to present any of those facts with that kind of confidence.

Here is a bit of facts.

1.) All patients (after the protocol change in February/March 2014) have a biopsy of their tumors. Many patients that started at this time will have 3-6 biopsies. We were fortunate to be granted the request of biopsying distant tumors as well which provided Northwest with a much broader scope of how effective/ineffective treatment could be on distant sites.

2.) AT 8 weeks, patients are rescanned. At this visit, the day before getting your injection you consult with the doctors and they make a determination as to whether they feel the treatment is having any effect or not. We had progression but knew from biopsy's (and from comments from the doctors at MD Anderson) that we should try for the 4th injection due to the tcell infiltration that was exhibited, the extensive tumor necrosis that was going on (all despite the scans showing progression).

3.) Despite progression, we still went ahead and had a biopsy before the 4th injection.

4.) Upon returning for Week 16, things got a little more tricky as there was still progression, despite the injected tumor being dead. We then requested 3 biopsies (one again of injected tumor and 2 distant sites...one in liver and one in lung). It was confirmed for the 3rd time that the injected tumor had no live tumor cells, another liver tumor not injected had good tcell infiltration and a distant lung tumor also had some tcell infiltration.

I am frustrated with the wave of individuals that display such arrogance and confidence that the treatment is having no effect and actually presenting their information as solid fact, when it is very far from the truth. We (not a collective we) are learning very quickly in immunotherapy that FAST action is not always GOOD action.

Each individual in this trial I am sure has their own road they are traveling and we have been extremely impressed with the care that we received and the concern that not only the doctors have had, but also our dealings with people at Northwest and the MD Anderson doctors. I can assure you that MD Anderson and Northwest's relationship is very good and very collaborative.

I really hope and pray this treatment has amazing results and I see no reason to try and put this company out of business. Our experience was great and we have no regrets. I am frustrated by the delay in the release of results but mostly because I'm an impatient person. I would love to see these trials (L and Direct) finish and have the resources they need to do so.

I appreciate so much the information that many of you provide but be weary of many of these people that speak and model with such confidence but have no idea what actually goes on in a trial. I saw someone posting about a patient only 15 or 16 months out from treatment and comparing that this patient should have an mOS of 36 months. Problem with that comparison is that 36 month clock could have started 2-3 years ago when they first were diagnosed at Stage IV and began chemo or SOC treatment. Patients in the Direct trial initially could have failed UP TO four previous treatments. The new protocol has NO limits. So in essence, patients could have failed treatment for a couple years and five or six treatments and then are enrolling.

Anyways, Flipper, if you are reading please shoot me an email if you remember it...I had a question for you.

Best Regards