Replies to post #475767 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Thank you for sharing that recap Reefrad.

[Judge Smails 40]

Sounds like ASCO will be another Tote Bag moment, and nothing more….damn

[hoffmann6383]

thanks for sharing reefrad

[DavidW2]

I don't understand why you did not ask DI, if publication is not ready, why company arrange 5/10 event? That was HUGE MISTAKE!. That was not necessary at all if publication is not ready. Company can still keep waiting!

[extrooper]

Thank you for your update. I can see why the discussion settled you.

[sukus]

Thank you Reefrad for sharing. Great news.

[FeMike]

Yeesh, this summary of the DI conversation makes me want to sell even more. Not only do they not have a response for the NYAS short attack, but they’re right back to the same talking points. Can’t say anything til journal release, no idea when that will be, working as hard as we can, blah blah.

Looks like ASCO is going to be a dud. We’re back to sub $0.20 if that happens. This is an absolute and unmitigated failure on the part of management.

[MI Dendream]

See attached link. It is not clear to me that the EMA equivalent is deemed acceptable and regardless the discrepancy between the two registries was problematic. DI does not always speak with full knowledge based on reporting I have read here. My phone interaction with him led me to deem speaking with him useless not because of him personally but because he plays his role well.

https://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

1. Registration

The ICMJE’s clinical trial registration policy is detailed in a series of editorials (see News and Editorials and FAQs).

Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s trial registration policy.

ICMJE uses the date trial registration materials were first submitted to a registry as the date of registration. When there is a substantial delay between the submission of registration materials and their posting at the trial registry, editors may inquire about the circumstances that led to the delay.

The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. The ICMJE does not define the timing of first participant enrollment, but best practice dictates registration by the time of first participant consent.

The ICMJE accepts publicly accessible registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) that includes the minimum acceptable 24-item trial registration data set or in ClinicalTrials.gov, which is a data provider to the WHO ICTRP.

[Doc logic]

Reefrad,

Hard for me to trust anything NWBO says right now while in a battle zone under attack. For example, if clinical trials was really no big deal they would have cleared that up long ago because it was asked about long ago. They didn’t so I personally don’t buy that line. They don’t want to talk about this so they downplay it is my take. The rest of the discussion seems equally vague on purpose and that purpose seems in line with maintaining a defensive posture and an element of surprise for their offensive moves. Best wishes.

[olekbolek]

Reefrad - Thanks for sharing. But it makes me feel not so happy to hear that they dont have an idea when the journal publish this article. They cant say anything before. What will Bosch tell us at ASCO when he is still embargoed from the Journal? This will have the same effect as the 05.10.-stockquote-desaster. My fear is: they have really no other plan and nothing in background (Approval / BO) and wait whats happening next to react (maybe).

[eagle8]

Thanks for sharing Reefrad.

GLTU

[trocprofit]

This is extremely disheartening to me. "He did say that the talk, journal article and ASCO were on separate parallel tracks and not necessarily related. The article could come out tomorrow or in weeks, it is not tied to ASCO (my interpretation, ASCO may not be the big moment we are waiting for). Once the journal is out they will be free to talk a lot more. For now they are in damage control mode including getting the fake articles taken down (check) and even corrected."

Separate parallel tracks? That was never discussed or PR'd by company.
-TLD/Journal, that's all we have been told. Quiet period based on getting across THAT finish line.
-After 19 months of silence, they let someone partially reveal the data and that doesn't end the quiet period?
-After years of talking about the naked shorts and cabal, they don't see a massive smash down coming by doing that?
-And, apparently still in a quiet period with no Journal or TLD PR in sight? So, essentially they have not been able to defend themselves?

Awful and potentially open to liability based on fiduciary responsibilities, IMO.

[antihama]

Thanks Reefrad for your feedback. I don't agree w DI that not updating CT.gov was a nothing burger. A couple of negative articles and tweets changed the narrative of the NTAS presentation. And I'm guessing we may or may not get ASCO prolly depending on whether the Journal article comes out? And I was kind of hoping we'd get a LBA reveal on May 27th even though there were good arguments that since MB was presenting at the ASCO IET a LBA wouldn't happen.

The good news I get from your discussion is that multiple pieces of good news could happen i.e Journal article, Sawston update, and perhaps BLA/MA movement.

For me the biggie is getting news on the MHRA front and perhaps Breakthrough Therapy Designation from the FDA. BTD can happen a couple of months after submitting their TLD along with other Data to the Agency. Who knows they could have had that BTD meeting awhile back since they had internal TLD in their pocket for a while and we could get a PR any day now about it. That's what I hope happens but not to confident that it will...until it happens :)

[hyperopia]

Yeah right. Nothing to see here, move along.

The clinical trials update is a nothing burger and meaningless. The end point change has been publicly known for a long time. They submitted the update on the day of the presentation just as a cleaning up kind of thing. It has nothing to do with the share price or the journal article. It’s meaningless.

Everyone (including Northwest Bio) knew that they would be attacked when the data was revealed. Northwest Bio could have waited to have the data presented in a journal when they would be permitted to PR this information and somewhat control the narrative, and yet they did not. Instead they chose to have the data presented at a prestigious scientific conference, while they were embargoed by a journal. (almost like walking around NY City with blinders on, holding their wallets out)

Northwest Bio could have disclosed what the new endpoints were in their 10-K in 2021, but did not. Instead they only disclosed that the endpoints were changed as required.

Northwest Bio could have updated the clinical trials registry at any time, but they did not. Instead they chose to make the request on the day of the presentation. (btw- what do you think would have happened to the share price if the clinical trial registry was updated days prior to the presentation?)

Hmmmm, and you say that they just happen to know the exact number of participants (15) that were involved in the “attack” that day?