Replies to post #232859 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

senti, out of all these debates whether the interim took place in 2015 or not, whether efficacy was evaluated or not that time, whether NWBO was made aware of the Efficacy results or not, or whether NWBO was privy to unblined numbers that time or not, I think one thing has come out very clear and that is acknowledging patients are living longer that LLsaid several years ago. Accepting DCVax works is evident to such an extent that our AVII went on to claiming he visioned this patients living longer scenario several years ago suggesting NWBO should have revised their SAP to OS endpoint long ago. Mani and JR are not disputing efficacy but wanting transparency. Ex has been back and forth making sure the possible OS/PFS numbers while poking holes on everything Longs say keeping the board on our toes. So the entire board is now in a very harmonious situation giving up who is right or wrong sending Ego to YouGo and coming to some common ground: DcVax Works as signed by 69 attending physicians. This is such a great feeling, I think we should materialize this feeling bury the hatchet and moving forward to making some filthy rich money out of this stock. I invite AVII, EX, JR et al to start loading this stock as it is dead cheap now had they not started yet. Longs keep adding more as much as you can. We got a great team of investors/stakeholders in this board: cancer survivors, philanthropists, oncologists/radiologists/doctors, engineers, scientists, TA chartists, trial experts, experienced stock players and financial analysts, lawyers, and on and on. And LP et al wanted us to work it out to bring up the pps to a certain level and promised they will pick it up from there releasing good news. I think we are about to reach that stage now. When we collectively and coherently contribute to the positive health of this stock, I think LP et al are going to keep up the momentum taking us to new heights very soon.

[highwayman4life]

Senti~

I believe it's been 3 yrs since talk of a 60,000 ft jaw drop...you still holding your breath?

Heck, I'm still waiting for the $12M raise that occurred in Dec of 2014 (out of memory) that was suppose to launch the next phase of the Direct Trial to occur. Matter of fact, there's been lot's of waiting on what the prior IR megaphone spouted.

Have we had those 7 PR's yet pre ASCO 2018? Tennis anyone?:-(

[biosectinvestor]

I’m reading Avii’s posts perfectly correctly. You’re not following what actually happened and what was an intentional effort to muddy the waters on this exact point. It started with Adam Feuerstein, and the continued through 2016, and 2017.

When faced with the court decision, the shorts were shut up for some time, but now they are arguing, incorrectly that the 2017 case only referred to discussions of an IA for efficacy in 2013 or 2014, but not the references made in 2015.

This is absolutely incorrect and a lie. Not you, but others, and as I pointed out previously, the problem with some of the discussions that longs have had with the shorts is they adopt the words and ideas of the shorts because they will link to a page of a presentation, and then make a misrepresentation about the court case not pertaining to those references by LP, etc.

That is a mix of truth, the link, and untruth, the idea that the ruling did not pertain to those references too, when they were raised in court, and the ruling is as of March 31, 2017.

I don’t know how to get clearer than that, except to say, I’m not going to help the shorts come up with their next attempt to muddy the waters... which is what these little debates frequently do.

[longfellow95]

Senti. If there was an efficacy IA some time in 2015 ( and I think there probably was, because the protocol planned for one), it is only the DMC who would see the unblinded data, not NWBO. The DMC is unblinded at all their meetings, mainly to allow for monitoring of comparative safety.

At an efficacy IA, the DMC on the basis of their unblinded look, would simply recommend continue, halt for efficacy, or halt for futility.
Sometimes a company will consider a simple continue rec to be quite a big blow (or their shareholders might).
It all depends on prior expectations before the IA.

If you want to steal a march on competitors by expecting your interim data to allow you to stop early for efficacy, thereby potentially getting to market years early, then receiving a continue rec will be a considerable setback, as was the case recently with Toca, when a continue rec knocked 30% of the share price.

It would be perfectly normal and acceptable for the sponsor to see aggregate event rates, thus allowing them to estimate trial duration and undertake other future planning. And the sponsor will often be able to make reasonable deductions based on those stats.


Unexpected and unplanned events can always happen (protocol violations for example), and might require consultation with the FDA. So such an event may come to the attention of the DMC first, but then involve discussion with the Sponsor and the FDA.
Indeed a major protocol violation could lead to the FDA slapping in a hold, but could be entirely unrelated to actual interim efficacy findings.

[AVII77]

My intent is not to ever muddy the bulletin board. I make mistakes on occasion, and my posting history will acknowledge that. My purpose is to try to bring clarity if I think instead there is confusion on an issue.

Senti, Yes, you very often succeed in bringing clarity to issues.

Let me bring some clarity to the current issue.

Here in post 232486 he argues against the futility theory by noting that the interim was safety only and not efficacy.

In post 232494 I prove that wrong by citing a NWBO slide that very clearly says the planned interim was for both efficacy and safety.

Then he responds in post 232496 citing the 2014 NWBO press release and Furberg comments saying the interim was for safety only. Of course, this PR relates to the 66th event interim, not the 2015 interim.

At this point it is clear he is confusing the 66th event interim with the planned 2015 interim (do you like how I accurately characterized it as "planned"?)

As an additional reply to my post 232494 noting his error he introduces the Lerner lawsuit in post 232567 somehow thinking that rebuts the fact that the planned 2015 interim was to include an efficacy evaluation and somehow proves it never occurred (because he feels they could have amended the lawsuit).

Then the discussion morphs into the Lerner lawsuit as though that has anything to do with the fact that, indeed, the planned 2015 interim was to evaluate efficacy, an important point he never acknowledged he was wrong about. (He also never acknowledged he confused the 2013 interim with the planned 2015 interim => if he wasn't confused, why cite the completely unrelated 2014 PR).

And because the planned 2015 interim indeed planned to evaluate efficacy, you can't claim that it was only intended to evaluate safety as proof it could not have anything to do with the partial clinical hold and a futility finding.

In short, the attempt to rebut the futility theory using that line of reasoning (that it was a safety only look) fails and the only thing the attempted rebuttal succeeded in was muddying the discussion.