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Ex. I previously thought there was no NHS reimbursement, but now I'm not so sure.
Certainly for many UK Specials treatments, there is reimbursement.
The NHS maintain an annually updated tariff of UK Specials treatment prices for purposes of reimbursement.
And the NHS spends a lot of money on UK Specials (either 1% of budget or was it 2%; I need to check).
I'm not saying NWBO is reimbursed by the NHS, but I'm not discounting it either. I need to research the issue some more.
I have noticed that there has not been any recent UK Go Fund Me people looking to fundraise for L treatment.
And as I said previously, NHS funding might dramatically change the numbers, though I also think the NHS would cap expenditure, which in turn would cap the numbers.
I think masks are fairly safe, but do not have any trials I can cite
The trouble is, CT, that KD may genuinely have had entirely personal reasons for upping and leaving, that had nothing to do with the trial or anything else to do with the company.
Perhaps unlikely, but may have been the case.
And if questions are asked about an individual staff member, the answer we will get is 'KD (or whoever is being referred to) made his decision largely for personal reasons, and thus I cannot go into further details.'
There might be some mileage in phrasing things differently.
Maybe; 'In what ways was NWBO able to benefit from the experience and skillset that KD brought to the company during his period of tenure?'
Just my opinion.
The trouble is, it's a human trait to want to satisfy people and tell them what they want to hear.
And if you are in IR, it's almost obligatory.
DI is not about to start shareholders; 'everything is on hold, we're down to our last dime, might be a good time to sell your shares'.
So he will always be inclined to intimate that something good is just around the corner. And that's the nature of an IR job.
Whoever is in those shoes is likely to communicate in the same way.
Last years ASM was a case in point. I think it was JJ who stated that the coming year was looking good (or something similar).
And the majority of shareholders seemed to come away from that with a bit of renewed confidence.
But a year on, I guess, for at least some, that feeling has dissipated somewhat (or gone completely for others!)
They do need to tweak the overpromise/underdeliver ratio a bit towards underpromise and maybe occasionally overdeliver, and I think they themselves know that.
And let's face it, everybody knows they simply haven't got the resources to actually commence a Direct P2.
They got the rGBM trial using Keytruda going, because it's largely SPORE funded. Which means it's not really their trial and the DC vaccine can't be called DCVax-L. And there are unanswered questions about data ownership rights. If the non-Keytruda arm proves superior (which is likely, imo), Merck is not going to want li'l old NWBO trumpeting the results everywhere...
So near enough everything they say on future trial possibilities should be prefaced with a 'when resources allow'.
I still want to hear that they have the ambition to move to new trials as and when. Basically, what is the scientific plan going forward.
So tell us that they are still ambitious, but don't give timescales that can't be kept.
Just my opinion.
Well, in my own mind, I'm beginning to question blanket lockdown policies. Well, I always had doubts.
What happens when you get to June perhaps and try and start relaxing? Another flare-up, another lockdown? Unless you know via widespread testing (including the antibody tests) the extent of virus penetration in the population and the number of recovered individuals (including those who had no symptoms) you will be relaxing restrictions without really knowing what will happen.
I note that the US is really getting on with testing now, and that will help their cause no end, in making informed decisions down the road a bit.
Meanwhile, S Korea will just continue doing what they're doing, because it's working (and so is their economy at least relatively speaking).
France just went through the roof on its daily total.
40% of all its tests since the outbreak began have been positive.
Which is a bit shocking.
S Korea's figure is 2% (on a much more proactive testing regime).
Sweden still has nothing like a lockdown, and so far their figures are comparitively low.
Remember S Korea has never had a lockdown at any point, and has clearly been the most effective country at minimising mortality.
https://www.worldometers.info/coronavirus/#countries
My prediction is that pretty much every state will be significantly affected once this is over..
The review of the advice on wearing masks also came about as frontline doctors and researchers understood more about how the new coronavirus spreads. They now believe it can infect people not only through the mouth and lungs but also via the nose, suggesting that masks can help slow the spread of the virus.
I think they're going for some kind of accelerated approval in the UK and hope to have Sawston up and running this summer. Target is treating patients by year's end. Obviously, top line reveal comes way before that. They are confident. JMHO.
We know they spent $6.5 million, as I stated weeks back.
That was in the site valuation that was fully quoted in a financial filing.
They built the two cleanroom suites, put in a mezzanine to increase eventual total capacity by probably a further 30% and made running improvements to the site.
As far as actually equipment in the cleanrooms, yes hardly any.
That's what the $2m is for.
All we know is that they have at least one flow cytometer, but hopefully a bit more than that!
A very small amount compared to what is wasted on Keytruda.
(That might sound like a throwaway remark, but it isn't.)
WARNING: don't get distracted with Sawston, Sawston, and Sawston. Yes, it may be a game changer with Sawston runup/expansion for the fate of the company, aka the fate of our investment, let alone the interests of existing and future patients, BUT THAT IS ONLY FEASIBLE only if DCVax-L trial is successful and approved by FDA and/or UK, Germany and Canada. IF NOT IT JUST WASTES OF MONEY IN THE END!
I've seen something similar before.
It looks like a price list from NWBO.
Do you mind sharing source and how recent this was?
Thanks.
Hi 'diver.
Hope you can enjoy the break.
I appreciate you are ER and may not see follow-up outcomes, but I'd be curious about your experience and that of colleagues of how patients have done on repurposed drugs.
It appears that Chloroquine is best used earlier in infection trajectory, whereas maybe the IL-6 inhibitor would be used at the CRS stage (quite late on?)
Don't share anything you're not supposed to.
Agree with some of your observations on DCVax and the UK picture.
Beginning to wonder if the UK Specials treatments are part of some sort of MHRA-sanctioned research...
My suggested amalgamation of 2, 5, 8, and 12:-
When do you expect Sawston to be equipped, licensed, and operational?
To what extent will an operational Sawston allow for increased manufacture of DCVax treatments, prior to marketing authorisation, so that treatments can be provided to individual patients on reimbursed compassionate use programmes, such as the UK Specials scheme?
How many operating cleanrooms, and how many individual patient manufactures can be achieved per month in the pre-approval period, to service patients who have eligibility under a special programme?
Can you give us a projection on how many reimbursed treatments it is anticipated will be done at Sawston per month before approval, and to what extent this will be greater than the temporary manufacturing site in London?
And can you give an indication as to how this might translate into revenue for NWBO?
Yes, that is what they are currently saying, and so is the MHRA.
But lots of European countries are allowing off-label use of chloroquine, hydroxychloroquine, usually only within a hospital setting, and I'm compiling a list of the ones that are.
And I can link to evidence of that being the case.
Belgium is one that allows it (in a hospital setting), and has imposed a ban on pharma companies exporting it from Belgium.
In about a week or so, the EMA and MHRA will change their position.
I can almost read the PR now;_
'In the light of the increasing evidence suggesting that... the EMA now supports the off-label use etc etc.'
And then the UK will state that it can now be used in the UK, only to find out that there are no stocks in the UK, as it's all been exported to countries that started using it a few weeks previously!
(I should add that I, in no way, support ordinary citizens self-medicating with chloroquine, because a black market will appear overnight.)
Within the hour.
Senti. I will try and put together 2, 5, 8, and 12.
It's his homespun messages and the way he delivers them that is so funny.
'You can use scarves. A lot of people have scarves'.
The thing about masks is how western countries might lurch from one untenable position to the opposite extreme by making the use of masks/facial covering in public mandatory, with threats of fines and arrests.
It just needs to become the norm rather than the exception, no more.
And you can't really make it mandatory, unless the entire population has access to masks.
And you can't suddenly make available billions of medical grade disposable masks anyway. Which is what it would take.
Such masks must of course be made available to medics, sufferers and their households.
Donald is right again!
Any mask or scarf that covers nose and mouth affords a worthwhile degree of two-way protection. I'm sure further guidance on daily washing of your face covering will follow.
It needs to be a social expectation that when you are in a situation of public social proximity that you cover your airways with a mask or scarf.
Typical situations:- walking down the sidewalk, wandering aimlessly round the supermarket aisles, queuing at the checkout, in the bank/Post Office, strolling round the municipal park etc etc.
Again, wearing glasses offers a degree of one-way protection against the virus entering through the eyes, but that's when it really gets down to the citizen exercising their own judgement.
The whole point obviously is to cut down transmission rate, thereby cutting down new cases, relieving pressure on health services and hospital beds. Allied to the use of chloroquine, which clearly does in many cases prevent infected individuals becoming critically ill.
In turn, allowing for quicker in-patient turnaround, thus freeing up beds.
The UK is really the slowest (and appears the most intransigent), when it comes to adopting sensible measures that should have been implemented weeks ago.
Should anyone be interested in how the outcome of the US Presidential Election may impact their NWBO investment, the following decimal odds are currently available:-
Donald Trump 2.08
Joe Biden 2.42
Andrew Cuomo 44
Bernie Sanders 48
Mike Pence 60
Hilary Clinton 75
Selected others:-
Michelle Obama 280
Ivanka Trump 520
(Betfair prices)
The evidence in favor of chloroquine/hydroxychloroquine continues to stack up.
Here are the results of a new Chinese randomized study.
Not yet peer-reviewed, but meanwhile thousands of fatalities continue to occur around the world.
62 patients were identified as having COVID-19 and enrolled in this study, none quit (Figure 1). As shown in Table 1, For all patients, the age was 44.7 (15.3) years old, 46.8% (29 of 62) were male and 53.2% (33 of 62) were female. Patients were randomly assigned into two groups. There was no significant difference in the age and sex distribution between the two groups of patients, but there are significant differences in TTCR between the two groups. For fever, 17 patients in the control group and 22 patients in the HCQ treatment group had a fever in day 0. Compared with the control group [3.2 (1.3) days], the body temperature recovery time was significantly shortened in the HCQ treatment group [2.2 (0.4) days]. For cough, 15 patients in the control group and 22 patients in the HCQ treatment group had a cough in day 0, The cough remission time was significantly reduced in the HCQ treatment group. Notably, a total of 4 of the 62 patients progressed to severe illness, all of which occurred in the control group not receiving HCQ treatment. For adverse effects, it should be noted that there were two patients with mild adverse reactions in the HCQ treatment group, one patient developed a rash, and one patient experienced a headache, none severe side effects appeared among them. To further explore the effect of HCQ on pneumonia, we compared and analyzed the chest CT of patients on day 0 and day 6. In our study, pneumonia was improved in 67.7% (42/62) of patients, with 29.0% moderately absorbed and 38.7% significantly improved. Surprisingly, a larger proportion of patients with improved pneumonia in the HCQ treatment group (80.6%, 25 of 31) compared with the control group (54.8%, 17 of 31). Besides, 61.3% of patients in the HCQ treatment group had a significant pneumonia absorption. Discussion CQ and its derivatives have been broadly used as immunomodulators in the treatment of systemic lupus erythematosus (SLE) and other rheumatism [12]. As the pharmacological mechanism of CQ is further elucidated, its additional clinical applications, especially the antiviral activity, are also increasingly valued [13]. The efficiency of CQ has been proven in a variety of viruses, including human coronavirus [[14], [15], [16]]. Researchers have even reported both prophylactic and therapeutic advantages of CQ for SARS-CoV infection [17]. The severe acute respiratory syndrome caused by SARS-CoV-2 in several patients is quite similar to SARS-CoV in 2002 and is currently seriously threatening global health by triggering COVID-19. However, none specific drugs are available for the prevention or treatment of COVID-19. Recently, Wang et al. identified that CQ could effectively inhibit the replication and spread of SARS-CoV-2 in vitro [7]. Experts and guides for COVID-19 in China have also recommended chloroquine phosphate superior to the treatment of SARS-CoV-2 infection [8,9]. To assess the safety and effects of CQ in patients with COVID-19, we registered this trial in ChiCTR and chose HCQ (the sulfate and phosphate salts of CQ) as the intervention agent. The data in this study revealed that after 5 days of HCQ treatment, the symptoms of patients with COVID-19 were significantly relieved, manifesting as shorten in the recovery time for cough and fever. At the same time, a larger proportion of patients with pulmonary inflammatory has been partially absorbed in the HCQ treatment group, indicating the immune modulation and anti-inflammatory properties of HCQ in non-malarial diseases [17]. At present, the multiple actions of HCQ such as regulation in pro-inflammatory cytokines [e.g. Tumor necrosis factor-a (TNF-a), interleukin-1 (IL-1), interleukin-1 (IL-6)], antioxidant activities, also promote it widely performed in rheumatic diseases such as SLE [11,17]. According to current research, a higher pro-inflammatory cytokine storm existed in COVID-19 patients with a severe or critical illness, eventually affected the prognosis [18].For this, IL-6 antibody blocker, transfusion of convalescent plasma, and other therapies have been applied to counteract the cytokine storm [19,20]. Therefore, with antiviral and autoimmune regulation effects, HCQ should be a protector in SARS-CoV-2 infection. In the present study, the reduced risk of progression to severe illness in patients with HCQ treatment also explained the intervention effect of HCQ on the pathological process of the COVID-19. Although HCQ has proven to be effective, with advantages of inexpensive and easily accessible, its potential detrimental effects in viral diseases must also be taken seriously. Retinopathy is one of the major adverse reactions of long-term therapy with HCQ [21]. Besides, patients with rheumatoid diseases treated with HCQ occasionally experience arrhythmias [22]. Other rare adverse reactions caused by HCQ include gastrointestinal reactions, cramps, liver dysfunction, itching, headache, dizziness, insomnia, peripheral neuropathy [13]. Fortunately, deciding on individual treatment plans scientifically, monitoring adverse reactions timely, to avoid overdose, short-term application of HCQ is relatively safe. Conclusion Despite our small number of cases, the potential of HCQ in the treatment of COVID-19 has been partially confirmed. Considering that there is no better option at present, it is a promising practice to apply HCQ to COVID-19 under reasonable management. However, Large-scale clinical and basic research is still needed to clarify its specific mechanism and to continuously optimize the treatment plan.
64. That is why I said it was worrying.
Sort of like a bit of a joke based on a typo.
Dilution I take as read as a somewhat necessary evil.
Can't be avoided, but all efforts should be made to minimise.
2,5, 8, and 12 cover similar ground and could probably be amalgamated somehow, or grouped one after the other.
Though Kab's additional; What do your cash needs look like for the rest of the year could perhaps be a standalone. Or blended with 11.
6, 9 ,10 and 15 also cover the same terrain and I think could be amalgamated.
5 and 14 include assumptions. 14 is predicated on assumptions.
Don't think assumptions should be in there.
My view.
Not a bad post, JR, if I may say.
Though I don't agree with much of it, particularly your conclusions.
I doubt if Duffy wrote the FDA consultation submission. I reckon he had gone by then, and it has the mark of LP to me.
And I credited you for your DD in finding out that KD had departed.
But personally, I couldn't conclude anything from his coming and going. Simply nothing concrete to go on. Any assertive interpretation (including yours) amounts to a shot in the dark for me.
Share popularity and price movements that are not based on fundamentals could be seen as many things. Collective delusion is only one. Speculation, opinion, rumor, gossip, sentiment, analyst comment all play their part. Look at the wild fluctuations in TSLA even before Coronavirus came along.
NWBO is clearly an extremely speculative stock.
Real high risk of losing your stake.
All we really have to go on is speculation and sentiment, which ebbs and flows like the tide.
And you really could extend that to the whole capitalist economy.
It's fragile.
Along comes a black swan like Coronavirus, and all previous valuations go out the window.
But at the micro level, risk v reward in this case is still not totally unreasonable.
On your speculation on departures, are we talking company officers or shareholders? I can't see many of either going anywhere soon.
Certainly not most shareholders, who appear in for the ride regardless. And I include myself in that category.
Ok Senti.
How about:-
"When do you expect Sawston to be equipped, licensed, and operational? How many UK Specials patients per month are currently being manufactured for in London? At present, does current patient demand outstretch capacity to respond?
When Advent is working out of a licensed Sawston, do you have a target or expectation of how many patients will be manufactured for and treated each month under UK Specials?
How is this likely to translate into revenue on NWBO's balance sheet?"
Something like that perhaps?
Of course if the question was addressed at the ASM, I would hope that LP would flesh out a response by giving more color and detail, particularly about how much capacity and how many cleanrooms are being equipped now at Sawston.
It's a case of framing questions that will stand a reasonable chance of being answered. That's why I left out anything about what their margin might be.
Thanks a lot for taking on the questions collation.
Triplets?
How much?
Stock is crap. Rally will fail.
JD.
Your barometer readings are swinging wildly today.
I am guessing Linda is still dilating.
We know from other sources (mainly GoFundMe fundraisers and also I recall a copy of a communication from NWBO to a prospective patient) that the cost to the patient is in the region of £200k or maybe $250k.
But we don't know how that figure is broken down.
Fees will be payable to the NHS for use of any facilities beyond what would be used for a UK GBM patient receiving SOC treatment.
I imagine charges payable to the NHS might be higher if the patient is non-UK. This assumes that non-UK patients can access treatment under UK Specials, which I am not totally sure is the case.
So there will be a range of charges relating to leukapheresis, nursing care, dry shipping, consultant fees etc etc.
Plus there will be a manufacturing fee to the manufacturer, which will include the cryogenic storage.
That's the imponderable one..
But they can't move to Sawston until the facility is inspected and licensed by the MHRA and HTA. And they can't do that without having fully equipped facilities to be inspected. All workflow routines and QA processes must be set up and ready.
Barring mishaps (and there are enough of those around right now), I think the current intention is to having Sawston up and running in the second half of this year.
My own view is that this level of funding will only allow the equipping of enough cleanrooms to service UK Specials right now.
And I take the 50 a month figure with a huge pinch of salt.
If they were averaging half of that they would be doing well.
15-20 is more realistic. Every patient has to be properly referred by a UK physician and all the criteria met. And it's a huge logistical exercise to coordinate patient arrangements and patient care from Bethesda.
And these patients have to be well-heeled, have to somehow have heard about DCVax-L treatment, and be sure it is the treatment avenue they wish to pursue. NWBO cannot advertise in any shape or form (though they can issue a price list after an enquiry).
We don't know if there is one physician currently making all the referrals or perhaps several. But the physician in question runs a private clinic, as well as working for the NHS. And I imagine this is where many of the referrals emanate.
FWIW, I think net income (profit) to NWBO will be no more than £10m a year, after all costs including the Advent fee. But that would be £10m better than nothing.
And at the same time the Advent manufacturing team would hopefully remain viable because of the income from their fee.
It's sure a good question for the ASM. But not one that will likely be fully answered. We don't know if the ink is dry on the manufacturing agreement with Advent, or whether it is till being written.
But I think a question about an estimate of anticipated net annual income accruing to NWBO from this route might be answered, albeit with lots of provisos. We won't get an answer on fee breakdown though, for several reasons I can think of.
MHRA Guidance for Manufacturers of UK Specials
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/400232/Guidance_for__specials__manufacturers.pdf
I think people will be surprised at how much Linda's Advent takes to produce DCvax for NWBO
Those questions have been asked many times.
Ultimately, the proof of the pudding will be in the eating.
Given that NWBO will not get approval in the UK without the availability of fully licensed and inspected manufacturing capacity that meets all the necessary critical quality attributes and more general GMP requirements, however good the trial data is, then how else do you expect them to do it?
Imo, the 8K as good as tells us that they have run up to capacity at the London labs at CCGTT.
One can only guess, but the move to a licensed (it isn't yet) Sawston, could up monthly UK Specials from maybe 5 to maybe 15-20.
Which may just allow them to keep the road on the show (or show on the road, if you prefer).
What would you have them do?
Actual population of Seoul is 10m.
Donald rounded that up to 38m.
Yes, but the most crowded city in the world too, perhaps 38 million people in Seoul area alone.
Sigh...
For me, this is the bottom line on masks, from a guy who knows:-
(Next 5 mins or so)