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A) A Lump of Coal
B) The Usual
C) Something Fantastic
D) A Dirty Bomb
E) None of the above; there will be no stocking hanging tomorrow morning for NWBO longs or anyone else, so what will be in the bottom of it is moot.
If you feel A=B then you may select both Turtle.
Longstocking... I suppose.
also
I really enjoyed Bidon's speach as well as the video on the Genie project. Very encouraging stuff.
"I wouldn't say never! ". Thanks.
I forwarded your link to Zacks. The rep I have been talking to says the report was from a subsidiary that deals exclusively with smallcaps and that he was not aware of the subsidiary prior.
This all matters to me because I currently trust Zacks. I have learned not to trust most such advisories. They are apparently mostly for hire. Zacks seems to be truely independent.
The link you sent is for a month old report and shows a price target of $8. The recent report, ie yesterday, said $16. A big difference. Like Frank, I still want to verify if the more recent report is real.
Also still wondering if Frank is wearing colored contact lenses.
I'm watching the AACR webcast now. It is really good, though just getting to the Moonshot program.
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63&DetailItemID=484#Webcast
Right now they are taling about the project "Genie" collaboration for sharing genome sequencing information. I think they said 7 major research institutions are involved. Seems like an ideal number to work together to come up with formats and databases and legal protections and agreements. Once they have agreed on these things they can replicate the process for all research centers.
Excellent segment.
The government involvement will help with funding but also with legislation to deal with privacy issues... is my guess.
A big big deal! Something to be very happy about!
Nope. Zacks the stock advisory service says that they have never covered NWBO. It must be some other Zack. Maybe the one from saved by the bell. He may be trying to gain (the) street creds to keep up with Screach who was last seen in court facing felony charges related to a knife fight.
Frank Blunt: The article about the Zacks target change for NWBO no longer shows up in my Google searches. That makes me worry that it might not have been real. The Zacks website doesn't show any target, but you can get a free NWBO report (or is that an automatically generated offer whether they have a new report or not?) if you sign up. I might. Maybe initial changes first show only in those reports... or maybe it was BS.
Lots of posturing and manipulation as everyone is on pins and needles. A very strange time for smallcap biotech, but maybe NWBO's is the strangest situation of all.
Frank: Do you really have two different color eyes or are you wearing colored contact lenses?
?Macrophage infiltration results in Tumor defense? I will watch Dr. Prin's presentation again, but didn't he say at some point that if macrophages lead the infiltration of a GBM tumor that the tumor generates a defense in response that is problematic? Did anyone understand this, in the context of DCVax-L?
I know such responses are generally an issue, but it sounded like he was talking about a new find.
Not sure that is what he said, but twice that was what I though he said. Is this as opposed to DC infiltration? Does DC infiltration happen first with DCVax-L?
Northwest dumped a raft of disclaimers recently which scared some people. Myself, not sure what to think. Maybe I could read them this way: HE reimbursement is approaching. If the reimbursement is high, they will be in good shape, but if not, the lack of automated mfg processes for DCVax-L will be a problem.
There were other disclaimers that were disturbing, but it could be as simple as they claim; that their internal audits pointed to a lack of sufficient disclaimers. It is certainly true that getting the house in order has been a big priority lately, even if the motivation to do so has come from the outside.
But I need to add my own disclaimer: I recently argued that a single antigen approach to cancer immunotherapy is likely flawed due to a bottle-neck at the lymph nodes. That the body has to generate and store T-Cells for all possible non-self antigens, therefore there could not be a large number of T-Cells stored for each antigen.
I think this is a good argument, but I should not argue that a large immune response generating a large number of different T-Cell types ensures efficacy. Maybe the cancer can still fend off such a large, multi-faceted attack.
I will balance that potentially perceived negativity with this observation: This stock plummeted over the last 9 months for reasons that had nothing to do with product efficacy, as far as I know.
Hey Doc, "If they are tweaking the automated manufacturing process for Direct".
You posted something like this a while ago. I am pretty sure that in the last 10K they said they do have the DC mfg process for Direct automated, while they do not yet have the L process automated.
I hope, like many that for L, they have finished the process design and equipment build, and are at the stage of getting it approved. However, they definitely described Direct as being automated and L not, so... if not stating that the processes for Direct are approved means approval has not been granted, then both process are not approved, so that Direct being ahead of L must be in the actual process, not the approval. If that makes sense.
...assuming they need approval for a change in the mfg process for Direct. Maybe they don't need approval for that, being before starting phase 2. But still there might be safety concerns... so probably need approval...
But my main point being that in the 10K they claim to have finished the design and probably the build of the automated DC process for Direct.
I have only one foot in NWBO as I try to earn more $ to purchase $NWBO... so not in my interest to contribute much at this point.
Lost a leg in a death spiral... and now fighting a giant black widow for the last 9 months with a giant safety pin. (I have the safety pin, not the black widow.) And they both appear to be getting bigger all the time. So I am not going to say much more positive about NWBO.
"Could this be what's happening with NWBO?"
Yes. That could be what is going on. There are many possibilities and that is one of them. But let me ask you, could this be what's going on with NWBO?
Lots of details to be worked out, but it does make sense for NWBO/Cognate/(Someone Onsite) to be doing the sequencing.
So many variables. So difficult to move forward with infastructure plans, etc, with nothing nailed down yet. Soon the nails will come. Hopefully nails of joy.
"Gene Expression in GBM:" Even though the article is early 2011, it isn't yet common knowledge just how difficult this genetic testing is. How expensive? How long does it take? How accurate is it? How much tumor tissue is required? Can you use a just a biopsy prior to the main surgery? Does that have MET risks? And why is MGMT promoter methylation not listed? Does that make it 8 subgroups?
Which genetic testing companies do these tests for GBM patients, if any?
To me it seems that the answers to these questions should all be well known in the GBM community including us investors that live on related stock message boards, but I don't think that is the case. Not sure why.
"Is it possible all the delay is that we are not commercialized enough yet for manufacturing.".
That does sound like a possibility. That would be on the hopeful side of things. The side where good efficacy was seen during some kind of look at the data... (comparison to Celldex, or HE evaluating reimbursement... etc.). Huge potential positive if recent big $ went to that mfg effort for L and if the effort is successful. But other possibilities.
NWBO (LP?) did say that automation for Direct was complete, but not yet for DCVax-L. She did not indicate how close they are for L. Maybe awaiting approval of a developed method, or maybe still developing a method. Other possibilities?
CLDX's lead drug failed phase 3, strongly suggesting it will fail in it's second indication. Yet the share price drop since peak in July is the same ratio as NWBO, which is still awaiting phase 3 results, with some read on efficacy possibly in the very near future. That is very strange.
What team of snail-oil salesmen accomplished this? Whoever they were, they are very good at what they do, or they have a lot of help in the shadows.
Adam: I wasn't trying to explain it to you. I was talking to everyone else, but referencing your post. Sorry for the confusion.
I knew that thinking about ethics would make your head spin. To most of the world, there is a stench that spirals up from an Oncologist participating in the creation of such a "rule". It stinks Adam, and that is apparent to most normal human beings. But some people lack certain sensibilities. You can use that in court. I will testify that in my opinion you simply lack the ability to tell right from wrong. I have your back on that one Adam.
If you really want to embarras me you should quote me in a "Street" article or the Wallstreet Journal.
If you tie a 1kg gold weight to a 1 liter balloon full of air,...
...and put them in water, the balloon will buoy(sp) the weight.
I mispoke.
Of course the effect works as well for lead or gold... but you just might end up with gold at the bottom of the ocean.
The "F-R Rule":
If you tie a 1kg lead weight to a 1 liter balloon full of air, and put them in water, the balloon will bouy the weight. But if you then shove the pair down a few feet below the surface, the pair will sink with an accelerating velocity. The increasing water pressure shrinks the balloon, decreasing it's boyancy as the balloon sinks.
The F-R Rule was likely designed to have the same effect on small-cap biotech stocks. It is my understanding that "R" is a big pharma M.D.. "F" is a (not biotech) reporter hired by Cramer to write reports on biotech companies, then knighted as a "biotech expert" by Cramer nearly overnight. It is likely that the purpose of printing and widely circulating the F-R rule, referenced commonly as Feuerstein's "Investment Thesis", was to assist Cramer and Feuerstein's efforts to submerge all small biotechs with less effort on their part. There are scores of new cancer cures, depression cures, diabetes cures, etc., being tested by small biotechs at any time. To have to hammer on all of them constantly to keep them struggling would be a lot of work. The F-R rule, to the extent that it gathers a following via constant bill-boarding, sets a threshold depth (market cap), below which nascent biotechs will struggle for funding, thus struggle to increase their market cap. All AF and Cramer have to do is drive these companies down below $300M market cap, and the unnatural forces they have conjured then take over and at least assist in keeping these companies underwater.
Why would they do this? Cramer is associated with hedge funds that cater to the extremely wealthy. Extremely wealthy people do not generally want to take great risks. When they invest in biotech, they generally invest in very large biotech companies, not emerging small-cap gambles. So these small-caps are weeds to them... or suckers growing around the base of the large biotech trees. They need constant gardening to keep them from becoming competition for investment $. At the same time, keeping them cheap allows easier acquisition by large biotechs if and when one of their drugs proves out. It is a win win for Cramer et al. Hard to find people with the character to do the job, but apparently they have found the right people. AF clearly loves his work which oozes hatred with nearly every tweet.
Adam: You and Cramer hard peddled Celldex for years while hammering NWBO. Now it's time to shut the hell up until we get DCVax-L results. You can gloat again if and when DCVax-L fails.
Regarding your post about the need to hit GBM with a single bullet rather than a shotgun: I have nearly no background in this field, but even I see a serious flaw in your ridiculous argument, so I am curious where you got the argument. Was it the co-author of your investment thesis? Is he the genius behind your ridiculous model?
Even a layman such as myself can reason that if the body stores, within the lymph nodes, T-Cells for every possible non-self amino acid sequence (and it does), then there is a very finite number of each T-Cell type than can exist prior to an immune system response to a specific antigen. Therefore, the immune response to scores or hundreds of different antigens would in fact be orders of magnitude larger than the response to a single antigen.
Let me re-state that for the non-technical types such as political science majors. The immune response to a huge dose of a single antigen would be bottle-necked at the lymph nodes due to the very finite number of T-Cells for that antigen that reside in the lymph nodes upon first exposure. Therefore, your argument that the failure of the Celldex's snail derivative dooms DCVax-L is nonsensical. Your an idiot Feuerstein.
I take that back. Likely you knew your shotgun/bullet argument was probably BS to begin with. You just want $NWBO cheap in case you need to buy it after news of good results. Your not an idiot, your a conniving crook.
? Days to make substantive info public ? Biotech companies tend to find a way to plan out info reveals for big conferences, but they can't always control when data matures. How far can they stretch the reveal of an objective data milestone, such as when median OS for a patient population is reached?
I know that once they are slotted for even an abstract presentation, they can sit on big news until a conference. But what if data comes sooner than conference sign-up? Would they be forced to comply to the 3 or 4 day SEC limit to sit on such material info, or can they say that they planned on presenting at some upcoming conference... so sat on the data, even though they were not yet signed up?
Not necessarily talking about NWBO here. But take NWBO, and ASCO. ASCO usually starts about June 1. How far into the year would they have to be when an objective data milestone is reached to be able to drag out the reveal until ASCO?
Again, something appears imminent to me for NWBO, which I think will definitely not wait until ASCO. But just wondering about this technical issue in general.
AVII: The phase 1 long tail pseudos all progressed after the administration of DCVax-L, according to the notes that you provided. Wouldn't you have to assume that the vaccine had nothing to with the psedo-progression to write these off? I don't think that is a reasonable assumption given that such inflammation is the goal or MOA for DCVax-L.
If there were excess methylated mesenchymals in those trials, then that would be something to point at, but I don't think there is reason to assume that.
I think the number of mesenchymals is known, but not the number that are methylated... once again an important piece of missing information, as RK would complain, with cause.
But thank you for all that information AVII. (Not being sarcastic.)
AVII: Let me ask you something basic: When you call a patient a pseudoprogressive, are you certain that is always a determination made before DCVax-L treatment has started?
In the context of this early unblinded data that we are talking about: These long tail patients that you say were pseudoprogressives; are you certain that they all "progressed" before recieving any DCVax-L?
I said, "Say the trial overall is powered for .02."
The trial is powered at .02.
So not sure why I said it like that, but too late to edit it now.
"Why would they not just design the trial to approve the subgroup and also all GBM subgroups if the trial data supports that?"
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Short Answer: The trial would have to be too large.
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I am a tad over my head with these issues, but only a tad. One way to look at it is that it would take a huge patient population to be powered for the smaller subgroups, such as methylated neural. That group would be roughly 6% of the patients.
Say the trial overall is powered for .02. That is a factor of 2.5 more than they need, since .05 is apparently the magic threshold of "statistical significance". You might guess that such would allow a subgroup that is only 1/2.5 = 40% of the total population to show statistical significance, though this dependance might not be linear.
Depending on where you look, you might find mesenchymal to be 40% of the patient population by the way.
That is one way to look at it. Another way to look at it is this concept of multiplicity that AVII was pointing at. That perspective is: If you say you are shooting for efficacy in any of 12 different subgroups, then the chances that you will see efficacy in one of them during this trial, is substantial, because you have so many chances to win, even if an infinitely sized trial would not show any efficacy for any of the subgroups. For that reason there is the concept of "alpha spend" for every subgroup elligigle.
Maybe with 4 or 8 of 10 subgroups, as is the case here, there is still room to allow all subgroups a shot at winning... but I don't know that. I say 4 or 8 or 10 as: The 4 GBM types with and without methylation, and then the overall population (all the marbles) with and without methylation. So I see up to 10 different considerations for approval. I doubt they shot for all of those ten possible ways to win, due to the large alpha-spend required.
Hard to explain alpha spend. Probably because I don't fully understand it.
It could be that they are considering
1) Methylated Mesenchymal (a slam dunk if recent LL data is representative of Ph3)
2) All mesenchymal (a very likely win if LL " ": Conspicously 40%)
3) All methylated patients (maybe. Conspicously roughly 40%)
4) All patients (I don't know man...)
But anyone feel free to correct me. I am a sophomore here at best.
The long tail for mesenchymals has been visible for years. According to Dr. Liau in her recent presentation about the matured data for the early DCVax-L trial patients; the long tail of survivors in her chart understates the truth that many patients have many more years survival than shown. Years beyond 5 years.
The significance of that fact is that this mesenchymal tail phenomenon would have been recognized by NWBO prior to nailing down subgroups during the relatively recent redesign of the trial. Thus the mesenchymals, or the further discriminated subgroup within the mesenchymals, would likely have been selected as a sub-group fallback to the main patient population. If so, and if the efficacy in that group is anything approaching what Dr. Liau presented, then at least this large subroup is a near certainty for approval. In my opinion.
My biggest caviat would be that if they did go for all the marbles and failed, it might be possible that tremendous efficacy in this subgroup would simply not be considered. The motivation to go for all the marbles would be not only the larger market, but the much greater ease in tumor handling by physicians. If DCVax-L was approved for all GBM and possibly Gliomas, then there would be no need to test the tumor beyond whatever biopsy test they do now. Assuming DCVax-L became SOC, physicians would remove the tumor, put it in the cryo-container, label it, and hand it to UPS. That's it. Every time. Machine like.
A very large advantage to winning all the marbles. Worth risking losing the mesenchymal of methylated mesenchymal group? I don't know. Some have stated that the very strong powering of the trial at .02 allows enough alpha spend for them to try for all the marbles and also try for a subgroup or subgroups. Myself, I don't yet understand these things well enough to give an opionion. I hope they are right. They sounded like they knew what they were talking about.
Clarified: AVII, RK: What of the 5yr+ tail shown in the early DCVax-L patients for 50% of the mesenchymal patients, ie, for 25% of all patients?
Regarding your recent posts about the "SOC" reference patients for the early data presentations; That many of those patients did not receive full SOC surgery or other aspects of SOC: Flipper's rebutal may pursuade me, but you guys are scaring me. Hopefully I will eventually take the time it would take me to soak it all in more thoroughly, but for now, the gist of what you are saying is definitely concerning.
But what about that long tail for (50% of) the mesenchymals shown in the matured data for the early DCVax-L trials? That alone suggests a very large patient population and market. Roughly half of the mesenchymals are living past 5 years. That is likely to prove to be the methylated (roughly) half, and thus may be an identifiable population prior to treatment selection. If not currently identifiable prior to treatment selection, then likely someday soon such tests will exist.
And what of similar patients for other cancers? Doesn't mesenchymal mean connective tissue? If so, then apparently there is connective tissue in the brain. Likely there to hold the shape of the brain. Does mesenchymal tissue hold the shape of the Liver, the Kidney, the Bladder, etc, etc, etc? How large is the population of mesenchymal cancers; of methylated mesenchymal cancers? Temador as an adjuct to DCVax-L or DCVax-Direct outside the brain? Why not?
And if so; If DCVax-L is effective for such a large population, will the less expensive DCVax-Direct turn out to be effective for that same large population?
Why mesenchymal? Does connective tissue lack checkpoint function altogether, or perhaps has less checkpoint function than other tissues? Is that why your joints and associated areas are the most sensitive to inflammation when your immune system gets ramped? Maybe we will soon learn more about these things, but for now, whatever the reason, can you explain away these outstanding results for the mesenchymal group for the early DCVax-L patients? 'Cause if you can't, then let that be clear. Without that, you may have a legitimate concern, but it is no bear thesis, and your arguments are being interpreted as a bear thesis.
If your concern is the patients, then what about all the future methylated mesenchymal patients on the planet. Possibly 25% of all solid tumor cancers, operable or inoperable. Do you realy want to risk handicapping NWBO to the point that a potential treatment for these patients never gets full evaluated?
AVII, RK: What of the 5yr+, 50% of mesenchymal patients tail shown in the early DCVax-L data?
Flipper's rebutal may pursuade me, but you guys are scaring me regarding the lack of comparable surgery and possibly other important aspects of "SOC" for the patients used as a reference for early open label DCVax-L efficacy. Hopefully I will eventually take the time it would take me to soak it all in more thoroughly, but for now, the gist of what you are saying is definitely concerning.
But what about the long tail for the mesenchymals? That alone suggests a very large patient population and market. Roughly half of the mesenchymals are living past 5 years. That is likely to prove to be the methylated (roughly) half, and thus may be an identifiable population prior to treatment selection. If not currently identifiable prior to treatment selection, then likely someday soon such tests will exist.
And what of similar patients for other cancers? Doesn't mesenchymal mean connective tissue? If so, then apparently there is connective tissue in the brain. Likely there to hold the shape of the brain. Does mesenchymal tissue hold the shape of the Liver, the Kidney, the Bladder, etc, etc, etc? How large is the population of mesenchymal cancers; of methylated mesenchymal cancers. Temador outside the brain? Why not?
And if so. If DCVax-L is effective for such a large population, will the less expensive DCVax-Direct turn out to be effective for that same large population?
Why mesenchymal? Does connective tissue lack checkpoint function altogether, or perhaps has checkpoint functions that are less of a problem for DCVax-L for some reason? Is that why your joints and associated areas are the most sensitive to inflammation when your immune system gets ramped? Maybe we will soon learn more about these things, but for now, whatever the reason, can you explain away these outstanding results for the mesenchymal group for the early DCVax-L patients? 'Cause if you can't, then let that be clear. Without that, you may have a legitimate concern, but it is no bear thesis, and your arguments are being interpreted as a bear thesis.
If your concern is the patients, then what about all the future methylated mesenchymal patients on the planet. Possibly 25% of all solid tumor cancers. Do you realy want to risk handicapping NWBO to the point that a potential treatment for these patients never gets full evaluated?
More "challenge for the phase II Direct trial is to determine real progression from false progression"
2 Solutions?)
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I did not address the key issue of progression types in "solution" #1. I must have been thinking I said OS as the primary endpoint. I defend that in the solution 2 as a way to avoid the problems. Just use OS and include all progressives.
But I don't remember my train of thought. Guess you had to be there.
Maybe you just screen as: Methylated Mesenchymal with prognosis of 6 to 12 months.
And I do realize you are talking about Phase II Direct. Just saying that if that is the sweet spot for L, then there is a good chance that it is for Direct. Maybe they should try a group of the same for Direct.
"challenge for the phase II Direct trial is to determine real progression from false progression"
2 Solutions?)
1) Just do a single leg methylated mesenchymal within one cancer type or another shotgun, but all methylated mesenchymal. This would include Temador where Temador may not have gone before. Not sure that is Kosher. The idea being that the results might be so spectacular that they may get away with not having a control arm. One substitute for a control arm, however strong or weak, might be the prognosis that the last physician made, prior to the patient being involved in the Direct trial.
I don't know that there is a mesenchymal type for most cancers but I suspect so. Maybe somebody knows. Maybe you know, or the usual suspsects. I did notice with a quick search on the four cancer subgroups for pancreatic cancer that was posted earlier today, that the squamal category does relate in some way to mesenchymal. It might be mesenchymal, or close enough.
I also don't know that Temador would be useful on other cancers, but I know that GBM is not the only place it is used. There might be only 1 other cancer, but I don't know why. I know one reason it gets used for GBM is that it does cross the blood-brain barrier, suggesting that there are better chemotherapies for other cancers. But if it ain't broke, don't fix it. If it is safe for GBM it must be safe, at least at some dose level for other cancers... said the Doktor. It seems to work awfully well along with DCVax-L on GBM mesenchymals (with the huge assumption that the half of the mesenchymals in the super long tail are the methylated half.).
2) For a 2 arm study, maybe you are stuck with OS and the duration implied. But if you use OS and look at percentage gain in OS rather than absolute, there is no longer a need to remove early progressives. Maybe I am not thinking hard enough here. What is the need to remove early progressives (real or pseudo) in a two leg OS trial to begin with? For PFS, true early progression is a mess, a singularity, even if you can distinguish it from pseudo-progression, but in an OS trial, where's the beef?
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koman Wednesday, 02/24/16 11:14:55 AM
Re: CherryTree1 post# 54934
Post #
54940
of 54987 Go
NWBO - 12
CLDX - 156
AGEN - 175
For NWBO I initially used 4 (didn't realize their employee count went up). Not sure where you got your number for CLDX. i didn't check TZOR's figures for AGEN nor NWBO. I assume those are correct. His CLDX sqftage numbers seemed suspect so I checked them out. Use the corrected CLDX numbers."
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Kinda makes you wonder of NWBO had a bunch of contractors on the payroll that were not listed as employees. My last contract job states "Non-Employee" on the IRS 1099 income stub provided by the company for taxes.
CLDX and AGEN are larger companies than NWBO, but I don't think they are 13 to 15 times larger.
The bottom of this 10K attachment shows Alton Boyton as still President and CEO of NWBO in December of 2008. That is the date of the attachment anyway.
http://www.sec.gov/Archives/edgar/data/1072379/000114420409020743/v146005_ex10-62.htm
Linda Powers became CEO of NWBO in 2011. She was chairman of the board in 2007, but not president or CEO. She was not the one in charge until at least 3 years after the lease deals that are being debated.
"progression-free survival at six months, or PFS6, was met."
Are you sure this means 6 months benefit in median PFS vs controls? Or is this just pfs of 6 months after meeting the patient or something?
I'm not so sure they can roll onto other projects when things get slow. Probably not other mfg projects anyway, because other workers will already be working those jobs.
They could lend a hand to mfg-R&D, if any is going on locally, but there would likely be staff already in those rolls. Manufacturing guys rarely contribute to R&D. I worked in medical R&D for many years and I only saw one person ever come over from mfg asked to help out in R&D for any appreciable length of time. R&D people are pretty snobby in that way.
Wait: Not to say that mfg people are not useful to R&D. They are critical to good development. Any R&D person with a good head on their shoulders will informally check with the right people in mfg for feedback on anything in development that is in that mfg persons realm of experience. But that usually only takes a few minutes, and the mfg person usually never leaves their desk/table/whatever.
AVII: Why NWBO? I understand your story, and your choice to limit detail, but aren't there other biotechs offering cancer cures that you believe will ultimately prove ineffective?
I'm not asking you to stop picking on us. I am just honestly curious why NWBO? Was it some other early indication for NWBO that failed, or just a similar technology, or a similar company?
I don't want to pry. I absolutely understand and respect why you have put limits on the details. But is there anything more you can tell us about why NWBO?
Look at the bright side RK. Maybe they only fired the three employees to screw them out of their stock, then turned around and hired 9 more contractors to replace them. (Contractors don't get stock.). I don't want to believe this, but my most recent B&M about jobs was exactly that. I was fired on the day of an aquisition after helping the company get acquired.
More my point, a point others have made, a point you seem to want to ignore, is that a major characteristic of NWBO is that they have a tiny formal staff of employees and a very large number of contract employees.
Maybe that just means Cognate or Toucan as contractors... but I have always had the impression that it means the large complement to the current tiny staff that you would normally see at a company involved in an undertaking of this magnitude. That might be a very large number of contractors. Many might take up residence at NWBO headquarters where they talk among themselves about getting screwed out of stock whenever the boss is not around.
Although in recent months, probably not so much...
Housing prices are only up 20% now from 2008 because 2008 was the peak of the housing bubble. I can't find charts for commercial lease space, but it was probably similar.
That doesn't answer all the issues you brought up by any means, but do realize further that not only were property prices very high in 2008, they were climbing at a scary rate, so depending on just when in 2008 a deal was done, many would have felt relieved to nail down a longer term deal at the current rate.
Further, just because they found another space that was much cheaper doesn't mean it was a comparable space. From what I see in listings for the wider Bethesda area, there is a very large range in lease rates. Not quite as large as the drop you describe would accomodate, but about a factor of two anyway. Was the cheap new space also smaller?
"NWBO should have negotiated more favorable terms during times no vaccine was being made for patients."
That sounds totally reasonable RK. And you generally have very good arguments. But based on experience, I have some issue with this quote.
Two jobs ago I worked at an artificial heart company. Their mfg staff and related staff all had very specialized training. Some were super bright and or educated people, some were just regular Joe's, but all of them were working under very strict FDA guidlines that probably took a long time to learn to navigate. Further, they were a family. Breaking it up and then putting it back together again is not a small issue. Such would be even more of an issue if the family was a growing family. In such a situation, tearing it apart and putting it back together again would be an uphill battle.
Shutting off Cognate's funding during times of low production would have forced layoffs of skilled workers and would have broken up that growing family.
"Thanks for doing the arithmetic and even if as you say it is inexact it still shows that current lease arrangements seem very fair."
I'm pretty far back in the posts, so my apologies if this has been rehashed more than I realize.
But I looked at NWBO's current location on google street view, and it looks like a pretty nice area. I compared that to a list of rentals in Bethesda, and while most were in the $2.00 to $2.50/sqft/mo range, most did not look like there were in quite as nice of areas. When I try to locate offices in similar looking quality areas I see $3/sqft/mo. That space, however, might not be in quite as good an area as NWBO's. So NWBO's current space may be more valuable than $3/sqft/mo.
https://www.google.com/maps/place/Northwest+Biotherapeutics+Inc/@38.9834557,-77.0953847,3a,75y,190.29h,88.49t/data=!3m6!1e1!3m4!1smmRMZJtW8o1eRzCn-qS4ng!2e0!7i13312!8i6656!4m2!3m1!1s0x0:0x5a851978b6af9b76!6m1!1e1
http://www.cityfeet.com/cont/md/bethesda-office-space#pgNum=5
Comparing these number to the numbers TZOR extracted from the 10K's below, the $2.44/sqft/mo for the first lease is dead center in the typical values for the good but not best areas, and $4.07/sqft/mo for the second lease, while high, is absolutely in reason if you allow that it is a very nice area. And again, the currently location looks exceptionally nice. At least $4.07/sq/ft/mo is close enough to right that it would not make sense to freak about it without much further detail.
Nothing particulary fishy here. I feel good about this. The issue of how much space they needed aside.
That issue has other possible explanations that I feel ok with, ie, we don't know how many contract workers they were housing and we know that LP likes big spaces in general. And we don't know that she is wrong to like big spaces. With all her skills, and they are many, drumming up investment is her forte'.
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TZOR Tuesday, 02/23/16 12:35:56 PM
Re: Stillwell888 post# 54759
Post #
54768
of 54855 Go
Ok let's do a quick analysis of an estimate of cost per sq ft
As of 12/31/14 future obligations equaled $1.3 million
agreement #1 is 7097 sq ft and expires on 03/2018 (39 months (2015, 2016, 2017, 3 months in 2018))
agreement #2 is 4251 sq ft and expires on 12/2017 (36 months (2015, 2016, 2017)
$1,300,000 / 75 (39 +36) months = $17,333.33 per month per location (estimate on location cost but confirmed total cost, as one location may be more or less than the other, but the total cost is as stated).
Or lets look at sq ft cost
Agreement #1 is 7097 sq ft and estimated to be $17,333.33 per month, or $2.44 per sq ft.
Agreement #2 is 4251 sq ft and estimated to be $17,333.33 per month, or $4.07 per sq ft.
The actual rent per unit may be different, but based on the number of months left on the contracts and the sq ft identified, that is a rough calculation of the cost per month and cost per sq ft for each location.
Thanks. Please disregard the following statement from Celldex's unofficial 10K.
" We completed enrollment in December 2014 in ACT IV, a pivotal Phase 3 study in front-line glioblastoma. ACT IV completed its first interim analysis at 50% of events (deaths) in June 2015, and an independent Data Safety and Monitoring Board recommended that the study continue as planned. The required number of events to perform the second interim analysis of ACT IV were reached in late 2015 and the analysis is expected to occur in March 2016. Final data from ACT IV are expected by the end of 2016, although our expectations regarding the timing for the final data read out may change based on event rates."
I didn't misunderstand that. I was just asking your opinion on this screening question as someone that appears to have great familiarity with the trial. This screening question has been eating at my gut for some time. Sorry that it does not directly relate to your post.
I suppose with PFS as a primary endpoint, early progression becomes a problem for analysis. My question might be more appropriate for trials that have only OS as the primary endpoint. For a GBM trial with OS as the primary endpoint, I wonder if % improvement in OS over the control group would be a better measure than absolute improvement. I believe that might remove the need for screening out early progressives in the trials, accelerating the trials, making them more representative of true clinical use down the road, and removing error in distinguishing between early and pseudo progression.
Restated: For GBM trials that use OS as a primary endpoint there is currently some advantage to screening out true early progressors even if such patients showed the same percentage improvement in OS as regular patients. Since true early progressors have statistically lower OS with or without treatment, the absolute improvement would be smaller for that group. So making the primary metric percentage increase in OS rather than absolute would remove this advantage, and thus remove this need to screen out early progressives.
But, since DCVax-L has a primary endpoint of only PFS, as far as we know, it is not the same situation. No information in PFS gets added to the trial by including true early progressives regardless of whether absolute or % gain in PFS is the metric. They just dilute any true efficacy.