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Thanks John,
I had a feeling that might be the case.
And I guess I should chime in. When you said "good" in every sense of the word (re: my prediction that enrollment sped up) I should probably qualify that it does not mean "good" in terms of predicting trial efficacy outcome (for instance). It does mean, if the prediction is true, the first few patients made it through their initial treatment phase without serious enough side effects to derail the trial. In the end, you must do your own due diligence, and even if you think someone here knows what they are talking about, you must research it to draw your own conclusion.
Yes. MD Anderson also added another investigator to the trial.
It might mean….
the DMC does not want date pressure. If they are thinking about unblinding the trial, they need to take extra steps -- which at a bare minimum means conferring with the FDA. This takes more time.
IMHO Enrollment is now at high speed. The training wheels are off.
http://clinicaltrials.gov/show/NCT01882946
2 + 2 = 4
Patient scheduled for 27th, update to clinical trials occurred 3 days earlier. Some might say this is using individual clues and small house keeping change notifications to draw these conclusions. However, taken into the greater realm of surrounding circumstances, it makes sense. IMHO
As of January 27, 2014, MDAnderson Orlando was continuing to screen for enrollment. Trial coordinator commented highest interest in a trial she has ever seen. http://coloncancersupport.colonclub.com/viewtopic.php?f=1&t=45437
(This confirms Linda's statement regarding high patient interest. Enrollment will be fast. If successful in the phase I/II trial, enrollment rate for phase IIb/III trial would be faster.)
Keep it in perspective. Found this on Yahoo tonight.
http://shine.yahoo.com/parenting/terminally-ill-dad-writes-awesomely-sweet-daily-notes-004900455.html
Fox, here is something about NWBO's manufacturing capacity (one of the buildings) from a June 16, 2010 interview with Linda Powers. Since that time, additional manufacturing locations were initiated in other parts of the world.
Q: Where do you see this compound being manufactured?
NWBO's Linda Powers: Our new Memphis facility. It is far newer, far more efficient, far better equipped and located within sight of the airport and Memphis is a worldwide shipping hub for both FedEx and UPS. So it’s an ideal location for shipping all across the US. So point #1, the facility is more than a decade newer than the California facility which was quite old and inefficient in layout. Point #2, the logistic value of being in a worldwide air hub. And Point #3, the cost structure. To put it in perspective, the whole lease of the entire 35,000 sq. ft. facility in Memphis – the entire lease cost per month is less, actually substantially less than just the electricity bill was in California.
Q: And obviously that facility has been cleared by the FDA? You’re comfortable with the set up of the new facility?
NWBO's Linda Powers: Yes. You know who built the Memphis facility? Cell Genesys. Cell Genesys was riding high for years, neck and neck with Dendreon until 2008 when they completely crashed and burned and went out of existence. And Cell Genesys in those years, was spending 100 million per year on corporate operations. Those are the guys who built the Memphis facility. No sooner did they build the facility then they decided not to do that type of product anymore and they mothballed the facility. So we bought a brand new facility for cents on the dollar in a terrific air hub location.
I really liked Les Goldman's press release this morning -- regarding the large-scale expansion.
I once posted that I thought the one thing NWBO might overlook is a sense of urgency.
After reading this press release, my concerns were put to rest -- at least for the foreseeable future. (Of course, I will continue to pay attention and give my two cents worth.)
For those of you who did not review this PR (perhaps because you already read the 8K) it is worth more than a casual glance.
http://seekingalpha.com/pr/8763791-nw-bio-enters-into-agreements-for-large-scale-expansion-of-product-manufacturing-handling-and-distribution
To me, its pretty clear from today's pre-announcement, NWBO restricted themselves to Direct.
….Today that Dr. Marnix Bosch, Chief Technical Officer of NW Bio, will make a presentation concerning NW Bio's DCVax-Direct Phase I/II Trial for inoperable solid tumor cancers at Phacilitate's Washington BioLeaders Immunotherapy 2014 Forum in Washington, DC on Monday, January 27, 2014. Dr. Bosch will describe the DCVax-Direct technology and clinical trial program.
Interesting Day.
*I learned something that gave me a bit more confidence in the market. As Ou stated, there is no wiggle room regarding the Fair Disclosure Act.
* NWBO strongly reaffirmed their need to expand manufacturing, production and distribution. They reemphasized this is a large scale increase.
* FatCatBanker's prediction was unusually accurate.
* Beyond giving FCB his due, maintaining a closing price at or above $5.00 makes it easier for large institutions to get in near the ground floor.
* NWBO only wanted Marnix Bosch to speak about the Direct program today. I can see why. Had Marnix entertained questions regarding DCVAX-L today, with the way the case study session was written up in the conference's pre-announcement, Marnix would have been walking into a minefield. Without the DMC recommendation on DCVAX-L coming in yet, and without speaking to the FDA after any such DMC recommendation; any discussion may have seemed more like an attempt to share otherwise off-limit information. I think this measure of caution was warranted.
* NWBO held some gains today when the rest of the market saw mostly red.
* No DCVAX-L recommendation from the DMC, which tells me, IMHO, that the "large scale expansion" emphasis was not based upon any (otherwise unknown) DMC results.
* The Direct and L data is still in front of us. The time is close at hand.
Thanks Ou.
Something to keep in mind.
The announcement a number of days ago stated:
Dr. Marnix Bosch, Chief Technical Officer at Northwest Biotherapeutics will be presenting January 27, 2014 at 2:40PM at the Immunotherapy Forum in Washington, DC. The topic is Cancer vaccines: Learning from past successes and failures to deliver game-changing efficacy!
Industry case studies:
Latest clinical data from leading cancer vaccines in development….
Is anybody attending the DC presentation?
I do not think there is a simultaneous webcast.
Marnix Bosch will speak about DCVAX-Direct clinical program. 240 EST 1140 PST
The DMC decision could come at any time. I'm not stuck on any date.
Looks like he is working toward the DCVAX-L trial in Germany.
2009
Grant ($ 15,000) for a phase II/III study with dendritic cells in patients with stage IV Glioblastoma multiforme.
Thanks John.
I found this section particularly intriguing.
To date 48% of all patients with Glioblastoma multiforme Stage IV went in complete and long-lasting remission. This is remarkable, given that statistics from the medical literature indicate that with standard treatment, about 72% of all patients who have been diagnosed with Glioblastoma multiforme Stage IV die within the first year of diagnosis and only 1% survive three years.
These outcomes reflect the positive survival rates frequently seen in the patients at the Medical Center Cologne. Dendritic cell therapy has been an integral aspect of Dr. Gorter’s treatment for more than 10 years.
Merci! Bonne Nuit.
Yo Etienne555!
I'm not worried about Linda's take. Its just a redonkulous amount of money. I agree with everything else you said.
(Note: Depressing stat. 85 people have the same assets as the poorer 3.5 billion people on this planet:( In addition to being a part of the team to cure cancer (hopefully with Direct), she sports some other upcoming humanitarian companies that will benefit from her resources. I don't think she'll opt for the biggest yacht contest;)
1st Immunotherapy of Cancer Conference (ITOC1), Munich Germany, 12-14 March 2014
Welcome to ITOC1
ITOC-1 is the first European meeting intended to provide a platform for preclinical and clinical researchers in the field of immunotherapy. The concept is timely and necessary as agents have been licensed and arrived in clinical practice and many more similar drugs are expected to follow.
Due to the exciting developments of molecular biology during the past decade and our increasing understanding of the mechanisms relevant to the genesis of cancer, we have experienced a transition from disease to target-oriented therapy. This has a strong impact on the development paradigm of cancer therapeutics. Nowhere is this more apparent than in molecular targeted therapy.
The goal of the Conference is to provide a forum for discussion of early clinical drug development and address its unique challenges of drug development. The programme will focus on topics such as immunomodulatory agents, anti-cancer vaccines and monoclonal antibodies with special emphasis on translational research and biomarker development.
ITOC-1 is designed to provide a highly interactive platform. In so doing, it attracts a multi-stakeholder attendance connecting preclinical and clinical scientists, clinicians, healthcare professionals, academia and other stakeholders who are involved in the development of novel anticancer agents.
Hi.
I copied this from the yahoo board. Its by a poster named Patriot. He seems pretty no-nonsense and accurate. He also seems to contemplate an imminent DMC release -- some indication he thinks the financing is an indication of phase 3 early success (read post he responded to). Anyway, its another helpful perspective with slightly different emphasis.
I agree as 8K included both DCVax-L and DCVax-Direct immediate increase in manufacturing in US, UK & Germany as well as Israel where compassionate use has [] taken place since 2007. The pre-market Monday morning could be a sign of DMC update on the GBM trial.
Together, these Agreements provide for substantial expansion of manufacturing capacity for the Company’s programs, in multiple regions, as well as development of the necessary systems and logistics, and other near-term and long-term preparations, for large scale scale-up of the Company’s programs.
I think you are on to something. Hostile takeovers are more frequent than some might think. I once calculated how rich Linda will become if this company soars. Its a ludicrous astronomical amount. However, she can't hold the fort down singlehandedly. Cognate also serves in this defensive capacity. Once the anticipated lift off occurs, if Cognate/Toucan/Linda/and some of us loyal voters (combined) maintain enough shares, it will be difficult for any company to muscle in on NWBO.
Good point. Whether its a continuance or early success, we need to ensure their is no lapse in paying the bills. I lean toward this being a good omen, but I'm more attuned to the biotherapeutic side of things, so I'll probably remain on this steep business learning curve.
Additionally, as GPB points out, this move gives an even greater vested interest for success to those folks who are critical in launching DCVAX. Pristine manufacturing will be paramount, and as we all know, an increase in demand could cause a snafu. Therefore we must INVEST proactively to avoid snafus related to increasing demand.
John and Ou.
Ou, I did not see this coming so early -- you win. John, I agree it is a positive sign. I honestly believe that when this treatment hits, demand will be out of this world. Not just for brain cancer. I also believe that if Direct comes back with the results some of us expect, it too will have a compassionate use program -- a very large compassionate use program.
Remember everyone blaming Obama when we had that lack of vaccines a number of years back? And of course we all remember Dendreon. In fact, biotech in general is getting a rep for bad launches.
Not NWBO. Not on Linda's watch.
Its the weekend. Relax until 2am Monday, and then freak out. You won't get the news quicker than any other mere mortals. If you're long and within your means, you can sleep in on Monday. Be well.
Well said GPB. Very succinct.
Have a good weekend everyone.
I rarely comment on price action, but I think the day traders will start to take their money off the table over the next hour (75 minutes), and some big players are waiting to swoop in and grab more cheap shares at the end of the day. Maybe. PR coming After-hours Friday or Premarket Monday? We shall see.
I'm going to have to give that list again….
most of the post cites were wrong….standby….
Here it is
3037
3042
3123
3129
3299
3379
3386
3410
3429
3444
3466
3473
3538
3598
3603
Ou and FatCat, I think Ou takes the historically sound position re:
I have pushed Flipper and gpb to give their reasons for believing the recommendation will be to halt the trial due to efficacy, or at least to get their odds for it happening. It isn't because I want to debate anyone on it - quite the opposite, it's because I want to think we have a real chance at it. But a continue is the most likely IMO.
Astavakra.
I agree.
The Company also announced that the FDA has accepted an amendment of the clinical trial, which does not make any change in the treatment regimen, which leaves all data collected to date intact for use in the trial’s overall results, and which includes the following:
*Designation as a Phase III trial
*Expanded and enhanced statistical endpoint analyses….
*Addition of interim analyses for efficacy
Interested in DMC Protocol on Early Termination for Strong Efficacy?
Review Section 7.2.1
http://www.fda.gov/downloads/Regulatoryinformation/Guidances/ucm127073.pdf
Note: I've never seen an announcement where a sponsor or a company decides to continue a trial for more data once the DMC recommends stopping the trial for strong efficacy. It could be that the DMC would agree to withdraw its recommendation if the sponsor or company felt more data was needed. Or it could be a positive DMC recommendation would be announced, but the company would state it needed to continue so that it could get enough data for the FDA.
However, its my view that the interim analysis for this phase 3 trial has predetermined stopping points for efficacy that were agreed upon by the sponsor, company and the FDA back on May 17, 2012. So I do not see the sponsor, NWBO nor the FDA wanting more data if the DMC recommends early termination for positive efficacy results in line with predetermined stopping points -- if indeed those stopping points exist and are achieved. IMHO
Thanks. Cancer is on the ropes.
This is quite a journey.
Think of it this way Rene.
I'll start this by saying I hope all cancer drugs succeed.
However, look at all the amazing press BMY gets on Nivolumab. Take today's CNBC video for example. http://video.cnbc.com/gallery/?video=3000238816
or these articles:
Benefits Durable in Three Tumor Types, OncLive, August 19, 2013 [?]
Bristol-Myers shares jump on ‘beginning of the end of cancer’, MarketWatch, May 22, 2013 [?]
But now look more closely at the OS, PFS and Response Rates for this drug that is supposedly the "beginning of the end to cancer." They do not compare with DCVAX-L. Not even close. I pray for those taking that drug however, and maybe DCVAX-L compassionate use will also be an alternative for them. If DCVAX Direct results come back demonstrating tumor eradication….
The point is, small drug companies do not usually garner media attention like large pharma does.
BMY has a market cap around 88 billion, if we eventually get to that market cap, the price of our stock is too high for words….
However, you must stay within your own risk tolerance. This is biotech after all.
Marnix on Monday.
"Latest clinical data from leading cancer vaccines in development."
2:40 in DC
Hodge,
Continued well wishes. My wife and her sister have raised tens of thousands of dollars over the years for Breast Cancer. She trains several months for a 39 mile walk each year. I myself beat a different cancer.
Our thoughts and prayers are with you.
Yeah,
--
I think on many boards, one expects to be insulted or slimed…and some of us (like me) can get defensive before stopping to think the statement might instead be a turn of phrase meant to ingratiate or laugh with (not at) someone.
Price runs:
I think price escalation, assuming the trial halts, is dependent on the PFS, OS, ORR and extrapolations drawn therefrom. If the PFS is 24 months or more, OS is 3 years or more and the response rate is 80% or more, the price could (immediately) well run much higher than 100 if a halt of the phase 3 trial for success was announced before Direct results. It will take some time (days to weeks), after potentially great results for GBM patients, for the entire world to realize (internalize) DCVAX applies to all solid tumor cancers. So look for a longer price-run-time before any slowing or pullback.
On any pullback: (I'll timely use ICPT for comparison).
*ICPT had a 'relatively small' but significant pullback based upon cholesterol concerns in a fatty liver treatment. DCVAX is not likely to have a pullback of that significance, because Cancer is extremely fatal, and while DCVAX really has no side effects, any DCVAX minor side-effects (beyond the chemo/radiation/surgery side effects) will be of almost no concern at all.
*ICPT may use their drug for other things like alcohol related cirrhosis -- if its efficacy continues to be proven there as well. DCVAX on the other hand is already being used on multiple cancers in compassionate use programs internationally. Therefore, before any pullback, super strong DCVAX-L results will likely have far more than a 2 day -- AKA: ICPT -- gigantic run-up.
* There are always things detractors will come up with to knock a company down a few notches -- like NWBO -- if NWBO comes back with spectacular results; but, waiting in the wings is DCVAX Direct, and if that starts to demonstrate tumor eradication on multiple cancers with strong indications of immunity, and that information is revealed to the public on the heels of the DCVAX-L results, then it will be very very difficult for detractors or anyone else to stop the price escalation. When it dawns on people that direct could be used on operable tumors as well…the run keeps going…finally, if it is intimated that DCVAX-Direct may potentially work on non-solid tumors as well (when administration is modified), than you get the highest price of all.
* If Powers splits the shares early and significantly, she could actually keep the stock affordable enough that even old shorts will buy it, and thus, the run keeps going. In conclusion, Price to earnings is not always an accurate way to evaluate a stock -- when the entire world takes interest….I'll just leave it at that.
Diamond,
It depends on your priorities. He is always subtle/cautious, but there are two little gems (pun intended) I got out of reading it…. Especially if you already read his earlier articles and comments regarding NWBO. The exchanges just brought up by Austinmedia on Seeking Alpha -- a few posts back -- also expound upon his thinking -- as well as the thinking of NWBO supporters and detractors.