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You guys (non-specific) are starting to tick me off.
I was quite exhausted after a weekend of drill and spending two hours getting a 2 year old girl to sleep and I spelled TRIAL wrong. My bad.
Also, this nonsense about Linda (NW + MD Anderson conspiracy) submitting to ASCO to hold back results? That's QUITE an accusation. That's something the SEC could litigate over.
Don't think yourself into a tiz. Keep it within proper realms of possibility until otherwise prompted.
They are "encouraged" and wanted to be recognized for their work by the cancer community. Thus, ASCO. Getting accepted by them, in any capacity, is a money and respect multiplier. Not doing this and piece mealing us info is fine but leaves us subject to the shorts and shorttermed day traders.
We're in good hands. This "learning curve" stuff is BS. There's no way to be 100% correct and finite when it comes to TRIALS. I'm sure she's learning, but a Harvard degree keeps me from worrying then, say, a degree from ALL the universities below it. Linda isn't NOT keeping with the curve.
I'll hang up and listen. I'd also like to hear about tangible information like: what type of abstract was submitted and by whom. Let's handicap our bets with intelligent information.
Type of abstract submitted:
I'm having trouble gauging all of this. So, I'm going to have y'all help me. Below I have summarized the types of abstracts, their depth, and dates due (if applicable).
I all caps'ed the selections that I think applies to us, but, as always, feel free to tell me I'm wrong so long as you explain why.
Presentations:
Oral Abstract Session – 12 minute presentations “representing important clinical and transitional research findings.” Limited selected.
Clinical Science Symposia – “presentation of meritorious abstracts” by an expert that summarizes the field and clinical practice. May cross disease sites or disciplines.
Poster Discussion Sessions – small, grouped discussions.
*General Poster Sessions – poster boards, annual meeting includes Trails In Progress in each track to develop awareness.
Publications:
Publication-Only – “acceptable quality” not selected for annual meeting are put online. (Released May 14)
Abstracts:
Late-Breaking (LB) – “randomized phase II and phase III trails of which no preliminary data are available … by Feb. 4th deadline”, but for which the primary end point is scheduled after that date but before April 1. THE POLICY IS NOT A MECHANISM TO ALLOW FOR UPDATED DATA TO BE SUBMITTED LATER WHEN PRELIMINARY DATA ARE AVAILABLE BY THE ABSTRACT SUBMISSION DEADLINE.
*Trails In Progress (TIP) – (discussed in general poster session) all phases accepted, on-going/have not met endpoints for analysis. INCLUSION OF RESULTS WOULD BE IMPROPER AND STRICTLY FORBIDDEN.
Linda mentioned that, now since submission, they can't disclose information on Direct. That points me to these latter two.
Since Direct is not yet randomized, I feel as though we've submitted a TIP & not a LB. This, though, would mean that no endpoints had been met - that can be made public, yet - as of the time of submission.
Her additional comment of 'encouragement' (she's seen something) tells me that necrosis has recently, potentially been observed but systemic response, as she said, ~"will need a longer period to see."
We are co-authoring with MD Anderson, per Linda. Per the guidelines of the linked site it would mean NW Bio and MD Anderson, if selected, will send an expert each to represent the study - the authors.
My question is, who are they? Who could they be? We can take guesses at the unbounded possibilities of trail dispositions, but, it seems to me, determining who these authors are is more ... finite. Let's work on this.
Anyway, that's my stab in the dark. The link is below. Please feel free to pick apart my post until we think we know what's going on.
A friendly reminder: The annual meeting dates are May 30 to June 3. We will know if we weren't selected, if not announced, if we appear in a publication on May 14th - per the above details. After the DMC ruling on L (which I'm more bullish on every day), it's going to be a long 3 months. Hopefully, after a sturdy stock boost, a long, boring run UP past ICPT with updates on patient enrollment in der Vaterland.
I'll shut up.
http://am.asco.org/selection-abstracts-0
She did mention, however, that they (not NW) were "leading" it.
Did she mean, they're leading the trail, specifically? And therefore, as you said, will seem to be as co-authors, or, as in her words, lead author?
A little convoluted and dishonest if so. (Not meant to sound short-ish)
I'll still process this as a bullish indicator. You don't submit to ASCO early unless you think you've got something.
I read it as primary endpoint (necrosis) has been met in the trail's infancy.
I could be wrong. Examining more finite points ...
The hospital, who is leading the abstract, (nor the company) is not required to submit to ASCO. The hospital would only do this for marketing leverage. They would NOT author a negative abstract.
These things are all bullish indicators.
Only two disclaimers were given: the Service Agreements' timelines & Direct could get rejected by ASCO, even if good data is present, due to the immaturity of the study.
L is intriguing.
The company can't debate figures and request extensions. The only entity that can do that is the DMC. The study either, merely, requires more attention, OR, they recommended something that requires subsequent review ...
And, ladies & gentlemen, time has passed the point of termination due to futility/safety. That would've been long ago detected and ruled on.
"We are waiting to hear from the DMC any day now."
Would be a relieving thing to hear, at a minimum. Eliminate some guessing.
What are your 4-5 issues to key into? I'm watching Frau Linda right now to have an idea about what's different in her speeches.
Also, I confirmed and linked an SEC website that webcasts are good-to-go for disseminating information.
http://www.sec.gov/News/PressRelease/Detail/PressRelease/1365171513574#.UvW4FvldVfc
Could hear good news Monday, boys and girls. If the company did, in fact, hear from the DMC on Thursday, Monday is our day.
Thinking about adding CHTP. I know that's not the scope of this board, but is anyone else considering that play? Price run estimations seem a little low for me.
Double post
Pretty decent day for such a quiet board.
More conjecture, since that's all we got:
No PR tonight - bullish. (Bad mojo to release Friday post market)
PR "SHOULD" be pre-market Monday IF they have received and IF Linda is to announce new data. (It seems they're waiting on L to talk about Direct). The conference is still more telling than some want to believe.
Nearterm price objectives put us at $13.75 - bullish.
Thai food tonight - pad see ew.
Thoughts, comments, concerns?
We're getting close boys & girls.
Can someone point me in the right direction or paste already allocated information on OS between the previously post companies and NWBO?
We had a fantastic compartive list for PFS. I'm curious what OS figures are like.
Thanks in advance.
The worst of which has the hughest PPS. Not hating. Just pointing out that until we hear from the DMC, it may, still yet, not matter.
Wrong about PR.
Not regretting adding shares, however!
Calls down today. $5 puts up.
Tomorrow is the PR.
This conference has been part of the deal for some time. But, as per the yahoo board poster (and I checked), the CEO was not listed as a speaker - until this PR about the conference.
Speaking of the timing, why release a PR today, of all days, for the upcoming conference?
In my limited experience in life, you don't through your CEO into a conference unless there's really good or bad news coming. Why, then, would your CEO leave home office to discuss - or pump up - clinical trails that have been ruled on negatively? It makes zero business sense (to leave home office anyway).
Upon closer examination, this seems to be spur of the moment. This company is typically a pre-market announcer, very methodical. But then, on a Thursday after noon, they have a PR about Linda attending a conference to discuss the platform tech., the trails, and whatever other goodies. A Thursday during a very critical, past due ruling from the DMC.
One more thing to note, ad nauseum, the company has 72 hours to release findings. If made available today - as we've discussed here - Monday morning may not be deemed acceptable as it falls outside of the allotted time-frame. It would have to be tomorrow.
Pre-market - probably/probably not - as they may take the maximum time to prepare a PR. But you'd think it would happen during trading hours so as to maximize investor augmentation (if not-bad news).
I don't want to put out any "e-cred" on this, but I will be adding shares tomorrow morning.
Just some points to argue, ponder, and discuss.
#bullish
We are price channeling AFTER the teacup.
I'm not an expert but we are definitely in a new pattern. Triple bottom doesn't apply as new highs are lower, new lows are lower.
Tuesday morning was the end of the up trend - as of now anyway.
I think, again not an expert, we'll see a dolar or so drop - with no news - and any bounce above $5.1 will signal a new bullish trend.
Just my $0.02
(And I did call a finish at $5 one day ;) )
I'd love to be wrong, as always.
Smart Texas, diseased with an acute case of hope.
Everything is suspicious which is unknown. Our time waiting on the DMC, in my opinion, has passed a termination to safert/futility & efficacy. It is pushing continuance grounds and, any later than Monday, it might be a dreades CRL headed our way.
Still long. Just my hones, gut sentiments.
Wreck em
Winter wonderland here in Lubbock.
This stock is a 'bail now' for the weak willed. There's upside still.
Each day that passes will be wishy washy and blah, or each day that passes the more likely the DMC's decision is likely to be wishy washy and blah?
CRL would kill this stock and change my "long" perspectives.
Oh, sir, if you can, sir, elaborate please, sir, do.
CRT highlights in head and neck cancers. I imagine this would be preferred to ameliorate DC trails.
At worst, I see DCVax-L/Direct becoming "adjuvants" - of sorts - to the current SOC.
My gosh, I didn't realize that the patients had such a rigid SOC prior to DCVax-L.
It really does make you wonder what the vaccine could do for a healthier immune system.
For NW Bio to get approved, they only have to show slight improvement from the SOC.
I'm worried we'll get continued into oblivion or - worse - a CRL.
Mind blown.
Just like that, I thought my logic was solid. And now I have a new process of thought.
Good enough for me. Thank you.
I can't see them holding back any results of the good to great persuasion.
Is it safe to assume, then, that the Direct results are mediocre as thry are made second order to the L release?
Or am I missing something here?
Thanks.
Ha "If you can't handle the heat ..."
I'll spare you the complete cliche.
Thay said, it's getting a little warm. Good thing I grew up in Saudi or I'd be short!
Ha "If you can't handle the heat ..."
I'll spare you the complete cliche.
Thay said, it's getting a little warm. Good thing I grew up in Saudi or I'd be short!
This has been harped on before, but I found the terminology this way to be well put (concerning our timeline)
It is a good sign that it is taking so long. The DMC is required to act quickly if there are any apparent safety concerns and a decision to continue only requires no safety concerns...thus the data must be...interesting
In terms of acquisition, I would nearly contend that the compatiblilty with the FDA is something NWBO should pursue.
I know, to this point, there has been concern over the intermingling of accounts. I can assure you that my colleague on the yahoo board is now restricted there.
As far as legitimate conversation is concerned, I am long NWBO. I have not the time nor current ability to short stocks. I am also impassioned by the science here. I, as I'm sure most of you, have had close encounters with cancer. And, in my case, there's a history of brain cancer. I want this company to accomplish their ends for so many reasons.
That said, the lack of release is troubling. I understand the timeline was an estimation, is flexible, and is marred by the holiday season. But it makes me nervous that we've exceeded the final limit (pre-market). A Tuesday post-market release is what I fear.
The volume for the drop this morning can mean so many things. Perhaps one of you technically inclined ones can shed a light of reason upon this?
I think we've solidified a resistance level at $5. If this slope continues past that, I may worry.
I know, ti this point, there
Damn that NSA
:)
We're a team of posters within our bank. I'm the lead and focus here. I gave my colleague the OK to post that because, to this point, I have no reason to question him or his credibility.
He does have contacts at JPM. That I can confirm. Their knowledge here or brokerage capacities are unknown.
I, however, operate somewhat independently here, seperate from his commentary, and currently have nothing to report. I apologize for any confusion. As always, no information is final until we read about it the next day.
LOL ... that sounds like a turrible, turrible holiday!
But I like your intention.
Good DMC discussion. Thanks to gpb for the detailed description of what goes on. The holiday aspect could add 1-1.5 weeks to the normal window, taking it out to Feb 14.
Or ... we get an "early" early termination this week ;)
Vanguard triple dipped. That's what I'm talking about!
I can't speak to the physician side. I'm sure they have notional benchmarks that allow them to assess, at least in the safe confines of their own minds.
In terms of the statistician on the committee, it would be a horrible case of bias.
I'm not touting abilities, but majoring in math in college we had an ethics class (that I slept through), and I think I remember something about cross studies influencing analysis. And, not in all cases, but this case I'd argue fell within this borderline.
The statistician has to know that the nuances of the science change meanings within the figures: if looking at OS, a drug with less antigens gives the same OS as another with more antigens then there's a conflict. An apples and oranges thing. In an analysis he wouldn't be able to say, "Well, this has the same OS as drug Beta." It would be unprofessional. He just needs to say, "OS is X. PFS is Y." etc.
So, yes and no.
It can only help if no other medicine can do what DCVax can do (in a good way).
I appreciate that thorough, prudent response. The yahoo site I would've been berated. It's so nice to just have a smart discussion.
I had overlooked the holiday season. That is definitely a factor. Even so, it would be their, let's call it, seventh week on the job. Oh my gosh, maybe we'll have to wait ANOTHER week! Haha
I do feel a little better after your response. So I do appreciate that!
Go Broncos!
I think we're best to analyze why the DMC was expected to take 6-8 weeks (to analyze the interim results of DCVax-L).
What is the cause for the estimation in the minimum of 6 weeks, and the cause for 8 weeks at the maximum?
It seems to me, with little knowledge, that the minimum is the better side of the spectrum to be on. Like in ICPT's case, it took them 44 days to reach a conclusion for early termination. 6.2 weeks.
The longer path, it seems, would be to see through the processes, with no highlighting indicators, to allow for an effective continuation.
I guess, in my long-winded way, I'm asking if there's a chance the DMC will rule a termination after the maximum period?
You know, what will help Direct most of all will be L getting a termination :)