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I do agree with Tilt in that analyzing the unblinded data is a FAR easier process than the consensus building it takes to develop a SAP with four regulatory bodies. But this company does nothing in 1-2 days. That JTM paper with interim blinded data was pretty basic stuff and it took them 8 months to publish it. But the publishing process is time intensive in its own right. Peer review just takes forever.
Bad bet. Topline won’t come before the end of the year. They haven’t even PR’ed unblinding of the trial yet. Even if they PR’ed it this week, it will probably take 6-10 weeks to analyze for topline data.
Dr. Hahn is not a radiologist. He is a radiation oncologist. He is a cancer doctor, not an imaging professional, although there is some overlap.
Any radiation oncologist will be familiar with GBM. Radiation is part of the standard of care, poor as it is. I’m sure Dr. Hahn has treated patients with GBM.
He may not be familiar with our P3 trial, but there are only about 4-5 significant ongoing P3 trials in GBM. When the data is presented, it should speak for itself and be quite compelling. He should be able to decipher what a long immunotherapy survival tail would mean to GBM patients. All the oncologists I speak with understand it. Dr. Hahn is an oncologist.
I’m not sure how his view from the top will effect our trial, but he will be familiar with the disease and the frustrating lack of progress on treating the disease in the past 50 years. That can’t hurt, if our results are as positive as interim data suggests.
#Biotech $NWBO #ASCO19 yes R Perlmutter was in the audience I introduced myself and FWIW so wasn’t M Milken... I guess we’ll see what it worth.. down to weeks? https://t.co/iGjyeiZ4rA
— Chris LaCoursiere (@ChrisLaCoursie1) October 31, 2019
There is no way it should cost 50k to manufacture this vaccine. Maybe 2-5k at most with all the equipment, labor, and shipping costs. Obviously, the more we manufacture, the lower the cost would be for each vaccine.
Please provide evidence of trial failure. Why would they be working on a SAP for a failed trial?
And how can a blinded trial fail??
So many lies...
Don’t forget that management did all this work of hand picking the luckiest GBM survivors just to pay themselves a salary and rob and swindle investors over the coarse of the trial.
I did your job for you today Scotty. Can I cash some of your paycheck?
That’s not entirely true. Regulators will want to know if their SOC numbers compare with historic data. 10% of patients in this trial received SOC alone. I’m sure that if their SOC data deviates significantly from previously published SOC data that regulators will want to draw comparisons.
The problem with science nowadays is that it isn’t just science, it is consensus building. You can perform and trial and lay out facts in black and white, but scientists will refute facts based on dogmatic beliefs about politics, religion, or even their own personal financial interests. This is especially true in areas where there are opportunities to muddy the waters, like complex biological systems.
Unfortunately, government regulatory agencies have become organizations where consensus must be built. That takes time, even when it comes at the cost to business or public health improvement. Sometimes regulation is its own worst enemy.
So we wait while they build consensus on this SAP with four regulatory agencies and remember that this time pales in comparison to the time it would take to run a new trial.
In large organizations, there are infrequently better options and the FDA is huge.
That’s what makes the interim data on DCVAX so compelling. Rather than just extending OS by a mere 2.5 months, indications are that OS was extended by 4 months or more and the TAIL of KM curve appears to flatten out after 3 years, leaving a significant percentage of long term survivors.
All with no toxic side effects.
SNO talk was on a weekend. Her talk today was during market hours. You’re right in that the PR would have come prior to her talk.
Correct, but recall that the company had her discuss updates of the blinded trial data at SNO in 2018, then followed up with a PR after her presentation.
Does Dr. Liau announce this morning that the trial has been unblinded? If so, I would expect that NWBO will follow up with a PR on Monday.
I’m not very knowledgeable on the military rank. My analogy may have failed. The point being, it’s cold and dark with no trial news. Scotty seems to be capitalizing on that feeling.
Us longs are like a navy seal team huddled in cold dark waters while drill Sargent Scottie hammers us and tells us we’ll never make it to the end.
The pain will be how we achieve great gain.
Keep in mind that Mr. Bigger traveled to UCLA to meet personally with Dr. Liau. Since then, he has invested even more in the company. Clearly, nothing about their conversation deterred him from moving forward.
Mr. Innes at ASCO told me that he imagined we’d have results by the end of September, but it was all complete speculation. Alpha and I were all speculating with him at that point. Clearly, we were all wrong.
I can’t imagine why there have been trial delays, but they are working with four government regulatory agencies. Fortunately, the SEC is no longer one of them.
Dave also has pointed out that it doesn’t matter if the trial is completed in August or December, but it does matter that the efficacy information obtained from the trial is irrefutable. I completely agree.
I have confidence they’ll get it right.
The key to more value is more efficacy. I’m hopeful that our trial will demonstrate that and give indications for a broad array of cancers.
Totally agree. Even with approval of L, our market cap should only be 10-20 billion. It’s DC direct success and approval for more indications that takes NWBO up over 50 billion.
True. I’m hoping a successful trial will change demand metrics. My shares still won’t be for sale at less than $5
My shares aren’t for sale at these prices. Based on the volume I’m seeing, nobody’s are.
I do agree with this assessment. If there is no concrete news on unblinding the trial soon, we’ll be back to .15-.17.
After witnessing the trial for a couple years now, my guess is that Dr. Bosch, while thorough and observant in the science, may not have the personality or skill set to advance the trial to completion on a more expedited timeline. At some point, decisions must be made to get the trial to the finish line. I anticipate that this is why Dr. Duffy was brought on board. He has the experience of working in the regulatory environment to make decisions on unblinding the trial and applying regulators viewpoints with confidence. As Dr. Duffy gets up to speed, I expect things to move a bit faster to completion.
I will be pleased as punch when they announce the trial has been unblinded,
If it is a public offering, then the market sets the sale price. I’d imagine raising $150 million is not something the company wants to do as the price is going down. This announcement would seem to speculate that they are expecting news with would raise the price and this will give them the opportunity to raise cash along with share price.
Such a raise would be necessary to advance into commercialization.
Agreed.
It is possible that a change in manufacturing process plus a small manufacturing change necessitated the last patients after the hold go into the treatment arm to effectively evaluate manufacturing change effect on survival outcome. We just won’t know until the trial is unblinded.
SP predicts trial failure only. Success is not accounted for in the SP, which only means that a successful trial will cause a massive correction in SP.
Seems to me you’re blaming the nature of the biotech business on a CEO. Drugs cost up to 1 billion dollars to trial and develop in today’s world. Thus, if you have a unique idea, you need a bunch of money and a bunch of time to go through phases of trials to get to approval. Any CEO of any developmental biotech is going to lose money until there’s a commercial product. Late phase 3 means the time is quite near for approval and commercialization. I’d expect any developmental biotech to be running on fumes at this point after a 10 year trial. Our CEO has us 10 years ahead of the closest competitor. How much is that worth with a successful product in biotech? We may be about to find out.
Data lock and topline are imminent. SEC issue is over. Laser focus can be on the science.
What a big sack of nothing. They had some weakness, maybe due to Linda’s management relationship with a contracted vendor. Clearly nothing that adversely impacted our trial.
It’s amazing how technicalities can be used to go after tiny companies. Think of all the Fortune 500 companies that have material weakness and conflicts, yet continue to skirt them.
Glad this is out of the way. Let’s get the P3 trial across the finish line.
The SAP could have been completed months ago. The discussions they may be having with the FDA may revolve around BLA moving forward process if the unblinded data reveals statistically significant survival improvements. We just don’t know and won’t know until it is PR’ed. I’m as anxious as everyone to get it done. Management seems just as anxious, but they’re concurrently dealing with four government RAs. One alone would be a handful.
It also appreciated 10x after topline. AMRN has room to grow, but it isn’t as misprinted as NWBO could appear after topline.
This moves to $5-$10 with positive topline data and imminent approval
I think AMRN has 2-3x price capability today. NWBO has 100x. I think NWBO has more value than pre-September 2018 AMRN.
I think Dave Innes would have been far more polished, but Les did talk effectively about their dendritic cell technology. It’s hard to convey the promise of this science in a 20 min video. It’s way too complex, especially when you have two hosts frequently interjecting with off the wall comments.
Still, at least people are talking about the technology. Our volume doesn’t reflect a huge “buy in” from whatever viewership exists with the Biz Show.
Nope. Just alpha. I didn’t wager anything on timelines. I’m not as jaded as the apuppy.
All those extra charges = extra dividends.
Dave would probably appreciate supper club pricing on his payout.
Yes...it’s time for some shareholder outreach in Cleveland, WI. I’m sure Dave would love that trip.
I’d make him take you to Lombardi’s.
What is a lier? Is it a lifer that doesn’t give a f?