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Office Pool:
FatCat says ...
2-26-14 0815 EST
I'll reference you to flipper's posts. The trial is set up to meet this endpoint very well. And as Linda said in the conference, if we meet this EP we'll do so with a p-value of .01 of which only .05 is required.
Feel free, all, to correct if wrong. Wromg has happened to me once or twice.
Other trials had OS as primary EP and only one had better PFS than us. But a lot could've gone into that. Aside from that one, were leaps and bounds ahead.
1/3 efficacy of prior trials (which was about 6 months) being 2 months PFS.
N'est-ce pas?
Let's whisper to ourselves for a second that today's price action was leak related.
Would it jump like this on the leaked news of a continuation?
I would wager not.
Again?
I saw a post on the yahoo board about something floating on Twitter about GS and assumed it was old news.
Would be huge if they were adding.
Steep climb, fellas.
Hold on to your butts!
Definitely don't mind Euros on our P&L sheets.
So, it's a good thing we've coiled and jumped positively.
This is not necessarily a bad thing, correct?
Is this indicative of something?
THans in advance!
You guys are funny. "Across from the food court", "prime spot" yada yada.
Take a step back.
Northwest is betting the house. ASCO, dual continent strategies, & stocks and warrants to fund production of not yet approved tech.
A macro view shows institutional investment and a company not even blinking.
Do they know what's going to happen? No. But most cases where the worst doea indeed happen there's telltale signs.
This is a bet. A damn confident one. Nice to know they're in with us.
Last year was one booth. No abstract submitted.
This year, one room and four booths. One abstract co-submitted with MD Anderson.
I like positive trends.
The negative possibility is that it is terminated due to futility.
I'm not sure what else you want as the good possibilities range boundlessly, and the negative is terminal and singular.
These studies could prove to be inconclusive. Even in such an event, a continuation could still be recommended as safety, the primary consideration, is a foregone conclusion at this point.
If you track these posts prior, they detail the consistency of the trials. It is complex in nature, as it should be, and will have responsiveness seen in aspects and not in others. This is due, as noted by prior posts, to the ambiguous nature of GBM. It will be the majority that rules. Mind you, a third of prior efficacy needs to be seen for a positive ruling and the DMC is likely to rule in favor, within the ethics guidelines, in severe conditions such as these.
I'm sorry for your loss.
I'm surprised by our lack of bear runs.
Northwest to have 5 booths at ASCO. That's right, FIVE.
http://events.jspargo.com/asco14/public/ExhibitorList.aspx?&pagenum=10
I suspect that these are paid for. Good to see nonetheless.
I definitely wasn't looking for anything more than an objective thought on this. Though, I appreciate your consideration. I know this investment isn't certain. But I'm long anyway.
Thank you both for your reply.
I appreciate your thorough response. You seem to be really on top of this, and we all thank you for your insight.
Do you see any disadvantages here (aside from the trial being double blinded lol)?
Not trying to kick up dirt. Just figuring that your particular objectivity would be interesting.
DOUBLE POSTED
Seems to me that there's a lot of uncertainty in terms of general sentiments as far as the structuring of the trial.
My question is simple, if NW organized, let's say, the trial favorably to themselves, is this abnormal and a liability in the DMC's eyes?
It seems as most clinical trials would want to test for maximum responsiveness in the healthiest of patients and that this would not be abnormal. Shorts and AF alike like to tote this as a FACT that NW will fail. But it seems ... non-sequitor to me. I mean, here he is debating, and we have to qualify, GBM patients. It doesn't get much worse than GBM, period. It also seems to me that any sort of progress, in any capacity should be availale to the public.
I digress and restate my question: If NW
organized the trial favorably to themselves, is this abnormal in the industry to do so and therefore a liability in the DMC's eyes?
Thanks, guys. You're all awesome! Just as awesome as the charts look!
I impore you all to comment asking about the ASCO submission as a medical professional wrote the article. Their insight might be helpful.
No one excited that Franklin Resources reported 7.8% ownership today?
Kind of a big deal.
There have been three amendments YTD however.
Completely eclipsed by Franklin and all the other "hearsay" smoke out there.
13G Franklin Resources
Still hard to read these. I think they bought and are sitting at 7%
That was amazing.
Just profit takimg while applicable or some sort of indicator?
Capital Ventures International filed 13G
Shed 42M shares, now reporting 2% ownership.
Bad deal?
I think we're on the closer side of 66 than 80 seeing as we met our first interim a couple months late. That could've been for many reasons. But, either way, it would extend all estimates.
My question is, does it accelerate at this point? If the treatment was truly effective and led to the late triggering of events, it's likely that there will be a response multiplier. If the trial is ho-huming along as expected, I think we start seeing increased tumor progression in the control arm.
N'est-ce pas?
I don't know. The longer, the better.
Regardless, IMHO, even if the trial design did not have the above feature, we'd still meet the endpoints.
If we achieve 1/3 the efficacy of the prior trials in PFS we will meet our endpoint with a p-value of .01 of which .05 is the cut off - per Linda. (or was it 0.001? I don't remember the guidelines if it's 10% or 1% surety.)
I digress.
If median PFS was 6 months in earlier phases, we have to provide 2 months in the larger, randomized treatment sample. Meeting our endpoint with spots of unresponsiveness and systemic responsiveness, knowing that serve diseases get the nod ...
I think we've got a solid shot at termination due to efficacy.
Am I wrong?
If pre-defined in the trial design, FDA might be more likely to consider it as a potential subset for post hoc analysis approval (if necessary).
Old article
... It feels so good.
Lol
Thank you for your time and consideration.
Would y'all know where to find a place to keep track of call premiums?
He's a dirtbag shorty. He meant next to fail.
I am dinging him up on the twitterverse to see if it's based within any reason - no response. I don't think I'll get one.
I haven't seen him on anything NW Bio until now. I'm sure he's busy trading, but once he does some DD on NW he'll, at most, strangle it.
And, that's what I was thinking. Our trail seems set to be successful.
Someone on the yaho board is freaking about UCLA IRB & enrollment. Can anyone translate?
Thanks!
Nick Zheng, SA writer, tweeted (under handle @pick1998_2) that NWBO will "probably" follow VTUS.
Keep in mind this is the guy that yesterday wrote a detailed options play on Chelsea for SA which, I think, caused their day some unneeded drama.
Scumbag.
VTUS
Expected Feb. results as of 11-25-13, and the trial proved futile. Dang ol' placebo effect.
2 months and some change to rule on.
Pretty sure our timeline proves more favorable. Along with how our trial was set up. I see almost 0.5% chance we don't show, at least, 1/3 PFS of prior phases. The minimum is a continuation.
New to bio's came in around ICPT, watched others pop up, eyeing CHTP. Hadn't seen a VTUS yet.
Someone, please, talk to me softly.
So, if I'm reading this right, Mr. Mehiel transferred NW shares from his box company to himself?
Is that right?
Bearish? Bullish?
Kind of important we figure that out.
I saw it as: she's already marketing.
It's a heinous, medieval technology to soak a pad in toxic chemicals and insert it into the brain.
We have a natural remedy that works.
Pretty simple to me.
Anybody get a chance to check out the SEC filing? I'm really bad at determining if these things are routine in nature.
SEC filing today.
Something about shares.
Allow me to tip your balance.
At the risk of driving a point to ciritcal mass, ad nauseum, or what have you, it's a combination of things that are 'encouraging'.
The use of the word "encouraged," in reference to whatever data they have so far, does not tickle my fancy. I've seen my share of encouragement in my time and it's never based on firm ground, in fact, it's to establish such.
She said it in conjunction with a notice that we're submitting, with MD Anderson co-authoring/investigating, an abstract to ASCO. So early in trail, we are submitting a Trail In Progress to a prestigious organization to review, in part with the aforementioned prestigious hospital.
Direct is used, if I've read correctly, without chemo, so, again if I'm interpreting this right, they've seen necrosis (end point one) or, even better, systemic response (end point two). It's significant that a remedy, outside the standard of care, with little to no toxicity, could reach one or both of said end points.
A double-tap, you don't submit failing or indeterminate data for review.
You're fine. My emotion was targeting the Linda accusations elsewhere.
Carry on.