Replies to post #209769 on NorthWest Biotherapeutics Inc (NWBO)

[photonic5]

I agree diver. I want to be holding my shares tight when topline comes in. Lots of competing technology and drugs generating a lot of revenue to attack this little engine that could. It’s best we silently chug along until we reach the top.

[eagle8]

100 % agree iwasadiver.

GLTU

[sukus]

Excellent post.

[biosectinvestor]

Well said and I agree 100%!

[Looking4aprofit]

Iwasadiver.....well said!

[exwannabe]

I can imagine that the company would have been bankrupted by shorts had any news come out that PFS was somehow in trouble,

So they withheld material information in order to continue to sell shares at prices they could not otherwise have done.

Given that LP benefited by indirectly selling shares via the Cognate transaction, one might think your are accusing LP of fraud.

[abeta]

IA

Thanks for posting your thoughts.

Well put.

The $47 million pick-up was a real shot to the groin
to those wanting to see this fail.

So much so - that the remaining NWBO 17 acres
has become contentious.

Adam Feuerstein - on DCVax approval - thinking about
asking all the biotech boards here -

What is your opinion?

Given DC approval versus AF's articles since 2013 -
how would you value his analysis?

(still thinking about the language)

1
2
3

In closing, again thanks for your thoughts.

regards

[miltong]

"Whatever mode they're in I feel it's absolutely what they feel is best for the company and for DCVax's future."

Well said. Thank you.

[Idunno]

Fwiw, (which we shall see) I want to again thank everyone for your shared brain power. The last four hours of posts, beginning, I believe, with a..post..from Ex, followed by some well conceived and expressed points and counterpoints, by Longfellow (awesome) and Flipper (awesome), and Doc, Marzan, Shukus, iwasadiver, et al... I just can’t express my gratitude enough (from a former ‘C’ (ok, C+!) public school student). Thanks. Fwiw.

[JRIII]

Anyone who doesn't see the heroic effort it's taken to stay in business . . .

So you are acknowledging that the trial failed and that the company has known this for some time, yet failed to disclose it as required by law. And then you call this effort "heroic" as you proceed to bury your head further into the sand.

Nice try, but some of us do have quite a bit of corporate experience in the world of Big Money and Wall Street, and we know a sham when we see one.

[MI Dendream]

Diver, I agree generally with your sentiments, but your premise about the halt is not at all clear to me.

However, I think it's very clear to anyone who's followed NWBO and this trial and all the crazy things that have happened in the past 4 years that PFS and the idea of pseudoprogression from DCVax treatment (not from SOC) may have caused an issue.

Here are some of my issues with this idea of pseudo-progression wreaking havoc and leading to a halt. Given a fixed number of patients (say 330), then 1:1 randomization (165 per arm) is significantly more powerful than 2:1 (220 vs 110). Likewise 2.3:1(232 vs 99) is weaker than 2:1. Why would a company that is concerned about failure agree to weaken their trial? Why would FDA allow patients to risk experiencing an unknown adverse event from therapy if they felt current evidence suggested a lack of efficacy? Why would either cap enrollment below fully enrolled and thus also weaken power for OS endpoint if data was trending towards a negative outcome for PFS?

The company has stated that no efficacy peek occurred at that time. Generally, a futility analysis is performed on blinded data. There is a range within the measured outcome which informs the company that the study has likely failed, succeeded already, or should be continued. Often if the later is the case, companies will boost their chances by altering the protocol and adding more patients....hmmm.

Also, Early Access Programs are FDA approved and reserved for drug candidates where FDA/EMEA believe efficacy is highly likely or already proven. In my experience, these are only initiated prior to approval, but after NDA filing. Why would FDA allow at least 110 EAP patients if they questioned efficacy?...hmmm.

In my personal experience, outcome adjudication is performed by a panel of experts not otherwise involved in the trial. The adjudication process ran concurrently with the trial on an ongoing quarterly basis. At least 2 of the panel of 3 needed to agree to overrule the investigators decision. At the end of study, both the adjusted and unadjusted analysis were performed and submitted to FDA. Arguments over which data set more accurately reflect true outcome occurred during the label negotiations. In my area, this could go either way, trial by trial, and was sometimes inconsistent with prior drug studies in the same field.

Finally, the impact that pseudprogression would have, if adjustment leads to a huge difference in PFS outcome, on what is possibly a dual primary end point (OS), had already occurred If adjudication has not been performed in real time. Therefore, the possible benefit adjudication would provide to PFS is counterbalanced by a negative impact on OS. I just don’t believe the issue is that big of a problem.

An alternative explanation is that PFS was already positive and could be discerned originally on blinded dat (for example 110 events divided nearly evenly between to arms despit a 2:1 randomization). In this case, if a company were to choose to continue the trial towards another endpoint, FDA would insist on silence to preserve the blind amongst investigators and subjects.

MI Dendream

[sentiment_stocks]

Just to be clear, in case you miss my more recent post, I didn't vote to ask the IA question. I fully get what you are saying.

My two questions were: what is a more detailed, comprehensive time line instead of multi-months, and what are possible pathways to approval?

And then, after a conversation with Jack, it will be hopefully be asked what is to be done about the share price? I agree with asking this question, as it has been alluded to many times that they intend to do something about the shorts AS SOON AS they have their war chest. Well, they have it now, and I'm wondering what and when they plan to do something. It would seem the goal posts have moved.

To be perfectly clear, I'm one:
no longer happy with holding off on dealing with them (shorts);
and two:
I'd like to know if they are holding off, what are they waiting for?