News Focus
News Focus
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meirluc

01/16/21 7:50 PM

#348166 RE: meirluc #348160

I need help+guidance. Please read post 348160.
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VikingInvest

01/16/21 8:03 PM

#348172 RE: meirluc #348160

I find the gist of the conversation, as reported, very very positive. In regard to the time frame, I am not that worried as I have no short term need for cash or any plans of selling any shares for the next foreseeable future. It does make me think that there could be time to add to the portfolio over the next few weeks.

As for the first point, The statistical compilation is still ongoing, does not necessarily mean that LL and other people involved have not been unblinded to work on publication.

All the other points are really positive, which makes me sleep well tonight.

These posts should always be read with a critical eye, but it seems detailed enough to have actually happened, just not taken it for an absolute truth.
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10baggerz

01/16/21 8:56 PM

#348181 RE: meirluc #348160

Sounds legit to me. I still think they are unblinded and have sent requests back to the statisticians for more specific analysis and compilation needed for the Journal Publication.

Everyone was talking buyout as a reason for the ridiculous delay in the Q-3 2020 10Q. They were also saying that TLD was delayed because of the 10Q. it turns out it was a nothingburger, basically caused by COVID-19 and accounting issues (or at least this was the excuse for “NWBO time”).

The reality appears to be that NWBO is going it alone with the current staff that brought us the never ending story... er uh I mean trial, AT LEAST until TLD/Publication. This means that they will take 3X as long as is reasonable to expect and as they themselves estimated (6-10 weeks x 3 = 18-30 weeks, so no TLD until February/March at the earliest IMO.

I would love to be wrong and see TLD on Tuesday. If not, it doesn’t make me any less bullish on the data or mean I’m selling any shares. I will say that the bulls like hopeforthefuture (who predicted they’d cancel SNO) were right yet again. This is not “as quickly as possible” and it certainly isn’t helping any patients who could have been diagnosed and passed away between data lock and TLD.

Frustrated, anxcited and bullish.

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HappyLibrarian

01/16/21 10:22 PM

#348199 RE: meirluc #348160

There is cause for concern but not surprise and here is my guidance:

Above all, prepare for a longer wait than even grizzled and grumbly long term shareholders expect if this is true.

Beyond that here are some points:

First this an alleged conversation with Les Goldman not a confirmed one.

Second, if true, the fact that the statistical analysis is not even done and by extension the clock on the article publication and thus TLD has not even started yet is disquieting but not at all surprising. This does make NWBO’s talk of September 2020 for TLD downright scandalous and we have already established that they knew or should have known that September 2020 TLD was never going to happen when they gave out the timeframe.

Third, the fact that Les Goldman was “upbeat” and seemed sincere and trustworthy is at best meaningless and if anything a bad sign because that is exactly how he came across to shareholders three or four years ago when he knew or should have known NWBO management was going to force shareholders to wander in the wilderness far longer than they wanted us to know.

Fourth, the expectation about the 4 Day notice is worthless especially since it is plausibly deniable over the phone. NWBO has not even stuck to publicly given expectations with September 2020 for TLD being a great example that should still sting especially if the statistical analysis is not even done yet. So of course they will say they do not expect bad news. Who would? That is not binding and means nothing.

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biosectinvestor

01/17/21 5:16 AM

#348220 RE: meirluc #348160

Agreeing the 4 day rule is the law, but they do not expect it to apply is basically saying, yes, there is a 4 day rule... but it doesn’t apply, which is not saying anything. There is no such thing as a 4 day bad news rule. A lot of guys who trade may think there is so it’s probably good to not argue about it on a call. It would not help to say otherwise. Always agree. Otherwise that will be the subject of some idiot trader’s blog on Seeking Alpha.

If a company has news that someone else might say is bad news, but they have reason to still believe they can apply for approval and their drug / biological could still be approved, there is no “bad news”. “Bad news” other than total failure is highly subjective. And a surprising number of trials that have had “bad news”, over the years, have ultimately been discovered to have a potentially approvable product even after they failed their primary measures. There is so much subjectivity that the primary worry is just to avoid fraud lawsuits. The 4 day rule is not about common law fraud, it is a statutory disclosure requirement, and “bad news” is not the measure.

I learned a long time ago, given what people say on these calls and their own understanding, and sloppy understanding even of what they are asking, it’s not worth taking ANY of this all that seriously. On the edges, you might glean some vague comfort, they still have offices, they have not made an announcement yet, so things are still pending... other activities aimed at commercialization are still happening in the background.

But anything really important, is not disclosed.

And of course they are still analyzing. That’s also why “the 4 day bad news rule” is not a real thing. 4 days from what? When they figure it out? It’s mostly reassuring nonsense.

And the rule is a rule of thumb about being transparent, the 4 day rule is not applicable. But if they want to tell people this nonsense to falsely reassure them that they intend to disclose bad news quickly but they do not anticipate any bad news... it’s basically investor relations nonsense. Maybe a lot of people say this, but I have generally not heard anyone else say this nonsense for any of my investments in biotech and I’ve been investing for many, many years.

I would not take much of anything, any of these guys say too seriously when it is about pending news. And if Les is in the inner circle, he should not be taking calls. Honestly, I think his radio appearances are ill advised. He seems like a nice, earnest guy who no longer has the demeanor of his past experience as an attorney and is way too casual and chatty.

They need to have a properly determined, carefully structured message and stick to it. Period. If they were a bit less haphazard and more disciplined, it would really make their lives a lot easier.

They should have like 5 clean bullet points that periodically they review and update, period. A clean and consistent message. Never different.

- Data is being reviewed, and I do not know more than that or if they’ve made conclusions, but we will provide more info as soon as practically possible (I am not involved in that process, 4 day bad news rule? Yes, we would never disagree...);
- Sawston expansion and incorporating Flaskworks technology is proceeding with haste, and we anticipate this will make a huge difference for potential production;
- We have many new investors, including institutional investors. So this is keeping us busy.
- We plan to also publish our results, but like the analysis, I can’t give a timeline or tell you where we will publish...





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learningcurve2020

01/17/21 8:40 AM

#348227 RE: meirluc #348160

What I’ve been saying here all along...the Independent statisticians (IS) are still “working” the data, if they even have it at all. And, I’d bet the longer it takes the better, at least as far as leadership is concerned.

The last we heard the CRO was “arranging” to get the data over to the IS. We all now know there was no real reason for that late 10q except for maybe what they don’t want to tell us??

Show me where it says anywhere IS are working on the data. Instead they refer back to the “Arranging” PR and lecture us on procedure order, then blame Covid. Two most important paragraphs:

>>As previously reported, the data collection and confirmation process was completed by the independent contract research organization (CRO) who managed the trial and by other independent service firms, and we reached Data Lock for the Phase III trial on October 4, 2020. As explained in our prior announcements, following Data Lock the independent statisticians conduct analyses of the raw data and Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for scientific publication and for public announcement. During this process, any questions or comments from the experts will be addressed as part of the preparation of the results for publication and public reporting.

As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the resurgence of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays.

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alphapuppy

01/17/21 12:50 PM

#348252 RE: meirluc #348160

I guess the quiet period must be over. If Less is blabbing to Yahoo investor board members.

I always knew that it was BS when they said it would take the statisticians two weeks to analyze the data. There is absolutely no statistical work of any significance that I am aware of that hasn’t taken at least six weeks to do.

Statisticians are like lawyers and accountants. Nothing happens fast for them.

It’s almost as if these type of folks live in a space-time that acts like it’s next to a black hole and one minute of their time is 100 years for the rest of us.

So when Linda says it’s going to take 2 to 3 weeks for the statisticians to analyze the data she’s not lying, but she is living in a space-time next to a black hole. The rest of us however aren’t.

Basically that’s why there’s such a disconnect.