Replies to post #234585 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

I think that’s probably how they are going about it.

Two thoughts.

This is not typical, because this is an immunotherapy trial originally designed more like a chemotherapy trial. Dr. Hoos essentially states this forces granddaddy trials (like DCVax-l) to run the gauntlet of slings, arrows and mostly time. (I’m obviously extravagantly paraphrasing.). NWBO is doing this to succeed, and it is also doing it to establish a shorter template for future DCVax trials and combinations. Therefore, this tail of data in 2019 is precious. However with aging attrition, tail maturation is entering the realm of diminishing returns soon, imo. Therefore, I think they’ll fight for this year’s first two quarters of survival data to be included. FDA 2011 cancer vaccine guidelines, if I recall, which I think LP gave input to, is very clear that the FDA should recognize/honor the tail analysis in these types of trials if a tail develops.

LP and Dr. Liau in particular have been champions of nonproportional analysis, even though neither one calls it that.

So, in short, I think it is atypical but necessary and understood that the later survival data must be included in the analysis, which is why I believe Dr. Bosch stated they will use data up to the point of data lock. It will require real time validation, imho, in the form of data sweeps for survival events.

I think the SAB wanted 75% OS events instead of just 70%. Now I think we are running into a flat line KM graph, and NWBO is asking for a little guidance from the FDA in the form of a response to their SAP. I think the FDA will provide a response that allows NWBO to wrap this up, perhaps just shy of what I suspect the SAB recommended, because it would otherwise take too long to complete this trial.

[hopeforthefuture2]

At the risk of again getting my head bit off and Marzan calling me a liar and a short I will again jump in. But first to Senti much thanks.
Innes and I do not get along but he will communicate - in sorts. He on the phone was clear there is a soft data lock in effect now. I tried to get a time but as all things nwbo there is no straight answer - (and yes Marzan my hope for the future2 name has not been here long -Marzan try looking me up without the “2” on the end and will find I’ve been here quite a bit longer - lost my password and have again so soon will be “hopeforthefuture3” - and appreciate your apology but don’t call me a liar again unless we are face to face- come to az in the USA and we can meet and say what you want to my face)). We, DI and went around for a while and from that believe soft lock was from dec 2018 to feb 2018, so I just said let’s call it Jan 2019 so we can talk. DI mande it very clear whether it be nov 2018 or feb 2019 or the settled Jan 2019 there is no additional data for the analysis being collected now. It is set unless they decide to start from scratch. There is additional data they can talk to but not use for the statistical analysis with the future sap. Also made clear as Senti and Ex and Flipper and others know (and I did not) from speaking with DI there is no fda formal approval of the sap just an ongoing discussion and hopefully an agreement that the sap is something the regulatory agencies like. Clearly I do not understand why this was not complete long age as watching the 2016 Liau presentation (thanks to Senti) for the 10th time she told them all that would be needed to create a sap that could lead to approval.

Flipper you are the alpha of the longs ( and I expect your wrath but here goes) and you now seem to be taking all that Bosck presents as absolute perfect facts. I felt sorry for him as he was sent up to try and fill the time at ASCO with nothing really to say. Do you remember his presentation saying waiting on pfs events so they could then unblind? I certainly do. Do you remember Bosch next presentation after pfs events were past and presented the same slides saying waiting on pfs even after pfs events were past? I certainly remember. Now you seem to hang literal interpretation on his every statement. I have gotten past that and although far too long in the stock I listen but with a critical ear/eye. I am long because I watch the Liau and Prins presentations, not Bosch and Powers. I do think there is great possible potential but as you have said in the past the goalposts seem to always move. I was a rose colored glasses cheerleader at least to my group of investors (over 1 million shares less than 2 mil) until this last ASCO. I was watching it live with a fellow holder (50 k shares) and had been saying we will get a timeline not results and then again got the statement “told you they wouldn’t say anything “ (except soon) and that is what have been hearing since my first conversation with Goldman 3 years ago.
Flipper I do talk with Innes and Goldman before him and on occasion try to share here. I agree with you they should put out pr or 8k but they have not and will not so I call and try to get some clarity. I think you could do better talking withDI yet you do not saying “already did” but just as clear to me not asking the questions I try to get answers to. They are terrible to get a short straight answer from but do sometimes let some truth out. Flipper I do hope that your dream for progress from nwbo on July 4 is correct but have seen in your words “the goalposts move”. Wish you would take my challenge and call Innes
This I for Marzan - went back and looked (not real hard) but my first purchase I found was in 2015 at about 9.80 per share - not exactly something to brag about so yea have been here a while. May not have been my first purchase but that’s what I found and back then I did not know about ihub. Also for Marzan on cvm look at a charrt comparing cvm to nwbo from July 3 to today and yes I sold 9% of my nwbo and put it into cvm- look at the chart and do the math. And yes Marzan if you look at a 5 year chart of nwbo and cvm they are the same - total devastation. Fortunately I had never heard of cvm until April this year. Similar technology AdamF hates both of them but cvm is in relatively good financial shape just got added to the Russell 2000 as of next Monday and I already have a nice profit, watch and like management, they show they are using their own money to buy shares, only thing they do not have is Linda Liau.

Ok now blast me flipper and Marzan
Thanks very much Senti, Ex totally respect you