Replies to post #211386 on NorthWest Biotherapeutics Inc (NWBO)

[JRIII]

Blah, blah, blah. Same old, same old. Nothing new. No answers to any questions, and if you think that response to the timeline question counts as an answer, you are mistaken.

Y'all have fun at the ASM. What a joke.

[flipper44]

“3. (01 Hold): The FDA was involved with the hold and discussing it right before applying for approval does not seem like a wise thing to do.” Ike quoting Les

Jesus.

[flipper44]

Ike, he is acting like he knows interim efficacy results. Particularly his answers on 3 (hold) and 6 (pathway)

He is behaving as if the crossover caused confoundment. He could only know this if aware of interim efficacy results.

Why would he talk this way?

[exwannabe]

So two answers and the rest dodges.

The answers they gave that said anything:

4(18) All patients were randomized

8(3) No process changes

This is the second time Les has said there were no process improvements in the course of the trial.

BTW, the answer to Q1 was BS. Many companies are much clearer about their timeline.

[Virgilio]

I am wordless. Personally I will be selling ASAP. Good luck to all.

[sukus]

This is good news. If the trial has failed, they will not say anything close to this. This is good enough for me to know.

"The FDA was involved with the hold and discussing it right before applying for approval does not seem like a wise thing to do. "

[scotty3371]

i do not think linda tells les everything.

[sukus]

This also caught my eyes:

"His response was that they are continuing to be attacked by shorts but they are planning some big moves."

[CherryTree1]

Thanks you very much for all the work you put into this Ike and for sharing the responses with us - Much Appreciated!!!

[PHYInvestor]

Ike,


Thank you so much for talking to Les.
I think the most important question is the timeline and unfortunately the answer is too wag.
I even don't get if they really started the first step and completed it.

HE even does not say that, which according to your discussion with him, should be completed. But because it is wag, they are not accountable.

So frustrating :(

[Whitewater55]

Thanks Ike for taking the call and spending the time listening to his babbling. A lot of concerted effort was put into the development, consolidating, and formalization of these questions. In turn, he spent little to no effort in providing lackluster responses.

I gave them the benefit of the doubt. Now I have more doubt. Changing my votes to NO immediately. Without anything sufficient, I’m considering a sell off on Monday.

Good night.

[Whitewater55]

“They are adding some top-notch people to run parts of the organization”...

Can’t wait to vote on their salaries. Hopefully their top-notch wives are also available to join the fray.

[Ultraz2]

Thanks Ike, but I wished you would have asked about any IAs conducted after 2015? It’s obvious if conducted, they may not have been favorable, and why they are going for OS at this point imho. Hopefully, someone can ask this Sat @ ASM.

[abeta]

Ike - Thanks for your post

(1) you killed off two conjectures - in that we now know

--- 100% randomization and

--- one COMMON Milk Shake

(2) Therefore the 87 Alive or 92 Alive or whatever it is
now Alive --

-- are coming from -- ANYWHERE -- in the DECK - including

2012 - 2013 - 2014

and this may have influenced that KM Median Projection out to
58 months ....

================================================

This killed me - in that - its an answer

2. (10 Live patients): They do not want to be accused of cherry-picking the best data to disseminate at this point. They have tried to be consistent with the data they provide. These numbers will be provided when all of the data is revealed.

If I really didn't want to answer - NO COMMENT is the way to go.

But no ... no no no .... instead ....

I don't want to answer because the number could be construed as
a BIG juicy juicy Bing Cherry.

Thats the way that I read it ....

=====================================

6. (20 Pathway to approval): No one has ever done this type of trial or seen these types of results with a crossover trial. They are blazing new trails and looking at a number of possible pathways,

and may pursue different paths in different countries.

Statements made by Gottlieb over the last 6 months have been very favorable to NWBO

.

and may pursue different paths in different countries

.

I don't know how to parse this. i.e. some countries will jump
on crossover and some countries will jump on the treatment group
solely???

Beats me ......

Again, thank you for taking the time to organize, submit and
communicate back the answers from your list.

regards

[blue_skies]

ike - sounds like NWBO is doing their fiduciary duty by holding a ASM and not saying anything of real interest or substance.

To my way of thinking, the only thing that matters is unblinding the trial and releasing numbers. So when will this happen?

[beartrap12]

Thanks, Ike, for all your incredibly hard work. Unlike others I think we learned a lot from the company’s responses to our questions. We learned that they actually started the countdown to Data lock on November 19 and that the work toward data lock is ongoing. We also learned that they are planning a response to the short attack. Most importantly, Les talked to you about multiple ways they could move forward and how they may use different avenues in different countries. They also talked about randomization though I hope meeting goers question them about that one. To be off by 17 in the SOC but none in treatment seems a little odd. On that note I just want to tell you that I will not be at the meeting because of an ongoing injury to my leg, which I expect to be healed by now. But it’s continuing to plague me and I’m not comfortable going into the city and walking around on my own.
I hope you or someone else at the meeting will ask them about adjudication of PFS, whether it has started and been completed and whether it looks promising for extending medium PFS. I’m also interested in what’s happening with Advent, and it would be nice if Linda can address why she sold 3.5 million shares and whether she still owns 29 million shares and plans to keep them. Finally, can Linda tell us if she believes her new investment, INmune, might work with DCVax and how?

[vator]

Thanks for the time you put in.

The halt was FDA requested and no process change.

Pretty much says it was all about progression adjudication as patients were living longer.

Useful to me.

[vator]

I never thought for a minute the screening halt was about Germany or process.

Nice to finally get that settled. The question posed about the halt was important.

My hat is off to you Ike.

[inveterate]

Thank you, Ike, for your diligence. Don't you think that it would make sense for the board to put their thoughts together again to prepare a second list of questions to be posed at the meeting tomorrow now that we have had a partial response? It would give us a good chance to clarify things that did not seem clear from LG's replies to Ike.

[biosectinvestor]

Thank you Ike. This was fantastic work!

[Doc logic]

IkeEsq,

Thank you again for your effort. As I looked through the answers given numbers 3 and 4 stood out. In number 3, Les mentions FDA as being involved in the hold and yet FDA responded before to an investor query saying that there was no reason NWBO could not divulge the reason for the hold based on anything from FDA. That means that this answer is being witheld for another reason. Now Les may have been pointing to FDA involvement in randomization because the very next question states NWBO has nothing to do with randomization which is true but if a DMC suggests unblinding due to ethical concerns and the company chooses not to then.. FDA and or other regulators get involved. That takes us back to how question 3 was answered. FDA was "involved with" the hold. They did not just impose it.. they were "involved with" it. When does a regulator get involved with instead of just impose or withdraw a hold. Could have been ethical concerns and or conflict of interest based on what sentiment_stocks and others discussed. NWBO initiated the hold outside of the US and it was a snafu in Germany that caused the hold to be discovered in the first place. Then to top everything off the number of patients left out of SOC/placebo essentially match up exactly with the last patients enrolled into treatment on a 2:1 treatment to SOC/placebo ratio. Sorry folks but highly controlled trials seeking good science doesn't lead to highly unlikely coincidences showing up at the last minute. This is all being covered up the best way they could and it has worked pretty well but the numbers are just too obvious. Again, NWBO did not control randomization but regulators could have for the exact reasons mentioned. The multiple trial sites is just made up speculation by an entity not involved in randomization or potential intervention for ethical purposes. The wording by Les in these two answers is about as clear as NWBO is comfortable sharing at this point because beyond this there may be other more sensative factors involved in non disclosure related to the investigation. I nevwr wxpected any direct answers about thd hold because of this. As far as timeline at least Les mentioned a couple of months in each step instead of multiple months as stated before. Best wishes.

[hankmanhub]

Ike, thanks for your efforts on our behalf. Frankly, I did not think you would get as much of a response as you actually got even with much of it being very vague and evasive. I hope that if those present at the ASM might continue pressing and perhaps gets some small elaboration on a few points. In particular any clarity on the status of the pseudo review would be greatly appreciated.

I do have one question for you Ike. the language of Les' response in your email, I assume this is a summary of what he said using your words. Or is this perhaps a reasonably accurate transcription of his words perhaps taken from a recording or a short hand transcription of his words. Ie, how much can we hang our hat on the choice of some particular word or phrase etc.?

[TopelRoad]

4. (18 Distribution of final 31 patients): All patients were randomized. You can't just put a group in one arm or the other. NWBO had nothing to do with which patients ended up in which arm. Because of the large number of sites, the final randomization may not have been exactly 2:1 but may have been off by a few people one way or the other.

This reply surprised me. I hope this is the case.

[scotty3371]

ike,

i think we would have been better served asking linda powers these questions directly at asm.
i believe the answers and the depth of the answers would be different.

unless of course linda told les to call you and deal with it.

but good effort.

[cfoofme]

Thanks Ike for all the time and effort you devoted to this. As a thank you I clicked the "follow you" tab and hope others will also.

[Stinkysweet]

Ike thank you so much all the time you have put into this! I appreciate it so much!!!