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How can this even happen?….they have no license or certification at this stage to make anything. I’m reasonably confident that all income has to date come from making vaccines for self paying customers and the Mgt fee of 15% above capital costs for the fit out of the facilities. Things will change quickly post certification.
Rubbish…I disagree with you
I wish I knew….I’m looking at the MHRA - GMP website regularly. I don’t know what the delay is since inspection to certification but it’s either because it’s a brand new facility and so is a much bigger audit than for other facilities and so takes more time to complete or they had some non compliances that needed a re audit before certification. It’s just guess work on my part.
I believe Sawston will be excellent news but won’t move the SP up much. I’d be delighted to be wrong on this…..
Apologies if this has been posted already but the MHRA has updated its GMP certifications - a new approval was granted today - Hoeford Research Ltd which was inspected on the 9th of Dec
https://cms.mhra.gov.uk/mhra/gmp
No mention of Advent as yet but still time before the year end…..
I can easily see how you reached that conclusion….it feels like there is a gap missing in Mgt’s understanding of the external perception from investors or the markets. That perception by the markets might be right or wrong but Mgt are not at all in tune with that understanding and it then manifests itself on them taking a view that everyone is out to destroy them and they behave with extreme caution in anything they say or do and at the same time it leaves potential investors reaching a conclusion that they have feathered their own nest to the detriment of shareholders…..both sides could easily be true or miles apart from reality. It’s on Mgt to set the record straight and leave investors or potential investors with zero doubts about the integrity of their investment in NWBO.
I think three big things have contributed to credibility.
1) A massive campaign by AF and others to tarnish the reputation of Mgt by making a number of allegations of fraud and spurious lawsuits. You only had/have to look on Google and it raises a red flag. Designed to starve the company of investors and access to funds and they largely succeeded in doing exactly that so they had to do deals with the devil using warrants and getting delisted off Nasdaq in the process.
2) Mgt hugely under estimated the resource required to see this to the end and the timelines involved with a going it alone strategy at the same time as the data then needing to be reviewed outside the norms as it was breaking new ground. It took so much longer where investors like Woodford probably called for an alternative strategy as the cash burn would be substantial until TLD but he failed to win that battle and got roasted in the process. This probably put off other investors who could see the dominant position of LP and how it could be used.
3) Having being burned by (1) and (2) Mgt then compounded the issue by not saying much at all to anyone about anything - they have communicated the bare minimum even before the quiet period and LP has all but disappeared as the front of house person communicating with investors. This strategy is okay as long as the timelines don’t get extended to the levels which we have seen. That has not helped them.
Having said all that we are where we are and the company has stayed solvent and we are at the last inch of the last yard of a marathon. So kudos to them for their maverick style IF they deliver exceptional results. I’m not comfortable with the Advent set up and I’m sure that has raised flags as well but have to satisfy myself in the short term that this may have been structured this way for a particular reason…it will certainly become a very profitable business but until we get to see how this plays out I have to bite my lip on this issue. All just my opinion…..
FeMike - just from various discussions I’ve had over the years with Mgt. TLD could have been PR’d by the company months ago but they have made the decision that the credibility of Mgt is damaged to the point that it creates an opportunity to attack the integrity of the data if they just coughed up the results themselves and so to that end they have rightly made the decision that they will release a PR on or around the time that it is published in a leading journal after it’s been through an independent review process by peers appointed by the journal.
So the situation is unique and says to me that they have very good results and this extended delay is created out of a necessity to see any opportunity to attack the integrity killed off. Now I accept this process has taken a lot longer than they probably thought but in a way it’s better everyone reviewing it does a professional deep dive if as a result it may lead to a potential change in how GBM is treated globally.
Yes- I’m assuming it’s currently about making connections and understanding clinical pathways so when the data is public she knows exactly what to do to swiftly and confidently see this to commercial approval in Canada.
Providing NWBO don’t run out of cash and I don’t think they will…..any acceptance that this is being held down and being squashed by a cohort of hedgies - fact or fiction it won’t matter in the end as once this gets clinical approval by any of the regulatory authorities and the company is still solvent then the SP will correct or an offer to acquire the company at fair market value will be in play. TLD and a top journal might kick this off with a jump up in SP….but regulatory approval a few months later will 100% kill all short players if they are still actively trying to steal away the upside. If you believe in the science it’s just a matter of timing and cash flow.
Kristyn Powers joining NWBO is a bullish indicator. I’m just curious as to what she is doing on a daily basis. Do you or anyone on this board have an understanding of what she is responsible for?
There are two things certain in life.
1)Taxes
2) A quiet period
Everything else gets you 15 minutes parking in Brooklyn lol
Advent Bioservices getting certified will be very good news for shareholders of NWBO. It adds commercial scale into the mix for Europe. However seeing as we are bleeding daily and it’s not TLD I’m not convinced it will push the SP up much at all. Advent independently itself has a great future. It’s TLD we need in a top journal followed up by being on the mainstream news channels globally for a day and even then if we hit $2.00 a share within 2-3 days and it sticks it will be a good result. The best return for shareholders will most likely be to sell out to BP on or just before approval. Expectations of selling out or a partial sale of what one is holding in NWBO at TLD is high but the landscape is changing daily. I can see the comments now on here from the sunshine brigade post TLD……. “TLD is amazing and l’m 100% certain between now and approval that will be reflected in the SP…..be patient”
Good post…..
Only monkeys pick bottoms
I’m hearing the next offering will not have any warrants as part of the raise. They intend to offer shares alongside a complimentary fleece for every retail shareholder.
I blame the tote bag…..
Ok so in total it’s just you right?
Agree with you. I’m interested to understand who on this board is still claiming this is a scam?
I agree, I think the main players in this stock pre TLD are very aware of the situation. The opportunity to persuade shareholders to sell up based on guesstimates of timelines presents an opportunity. Mgt silence gift wraps that opportunity to players…..I suspect the majority of trades daily are short…day in day out.
Very funny and accurate
I’m inclined to agree with your thoughts on this. Chicken and egg scenario - they and only they can gauge the likely uptick in patient numbers going through at scale at Sawston post GMP certification but more importantly post TLD announcement….that is likely to create a surge in demand even at $200k a pop. Recruiting qualified staff takes 2-3 months and then every employee needs a couple of months to genuinely start delivering a tangible net difference. Seems a smart move. I’m less inclined to believe a BLA application but that’s just my opinion.
Seems we have an unrelated Advent already operating a GMP facility……
https://www.advent-gmp.com
I’ve also had dealings with a couple of patients, getting them on board with DCVax ….everything is handled by Advent although always initiated by NWBO
That would be nice….
That’s true and fingers crossed but we also know it’s possible he could speak for 20 minutes about something other than TLD if they are not ready…..but hopefully he won’t
Not by Friday no……it’s all about confidence. I believe investors are potentially confused by the last PR. You could read it a couple of ways -
1) It gives them the cash to continue in their strategy of being in a quiet period until they are ready….which could be Q1 or potentially longer based on their cash balance and burn rate.
2) Alternatively Mgt believe it’s necessary to have a reasonable bank balance before they announce TLD - meaning that the date is more likely between now and 6 weeks away…..
The PR gives no indication one way or the other and so based on experience of Mgt in the past it’s easy to wobble as you lean towards option 1……
I honestly don’t know what to think but still leaning towards option 2 so TLD is sooner rather than later in my opinion. Until then we will bleed….
Ex forgive me but I’m as certain as I can be that the cost + 15% is all about the Project Mgt of the fit out and scale up of the facility of which the assets belong to NWBO. The price to make a vaccine is not covered by that same formula. That is a confidential deal which is between both Advent and NWBO - the total revenue for a year on making vaccines is somewhere between 3-5 patients per month at $200k per patient. On my discussions with the head of the governance committee at NWBO it was made clear to me by him that Advent had very little or any cash available according to his understanding so I then sent across via email a copy of the last 6 years Advent accounts and asked if he could clarify that statement of having virtually no funds available. We again spoke and it then become obvious to me that these accounts had never been seen by him. I was promised a detailed response to my questions twice (via email) and I have never received any response until now a couple of months have passed. All I can say is that the situation is now more clearer by all parties at NWBO and I hope it gets properly corrected or explained to us all in the future. I’m long and I want every shareholder to do well. GL
That is true of the fee agreed in a contract to provide Project Mgt services of the fit out and certification. Perfectly reasonable costs I will add. It does not relate to the fee they receive to make the vaccines for those self paying customers. That is confidential but I will leave you to draw your own conclusions on that by simply looking at Advents accounts. Despite what people keep pumping on here about not having the liability of the complete staff costs believe me NWBO shareholders have footed the total bill. Apparently it’s better for us not to have the costs of the wages of all the staff at Advent but to have an even higher cost base to allow not just the the wages fully paid but to also pay $1m in profit tax over and above that….for an entity we don’t own. Bring on TLD and ultimately a successful conclusion for patients and shareholders.
Try being in this stock for the last 12 years…..lol
I agree with you Hyperopia as I checked online myself. The only evidence I have is Les told me specifically that a couple of years ago….now, I may have been mistaken in my understanding of what he told me but reading the documents myself it does not include any reference to being supplied at cost however recalling our conversation it was detailed and specific. I then much later approached the company directly over a high profile patient that was diagnosed with GBM and as I had approached the company directly it was possible to put them both in touch as the company was unable to contact this patient directly. The marketing element is included in the rules as being not allowed but no mention of commercial pricing/profit. You either believe what I’m saying or you don’t but I accept that I can see nothing in writing to back it up.
It’s the rules around being given permission to provide the vaccine for those that can pay. You cannot actively market it as a treatment option or make a profit from it.
They are all getting on in years….they have not ever significantly strengthened their team and or created a new younger leadership team and the appointment of that highly inexperienced CFO (before she realised what that involved and became CIO) and the separating of the manufacturing arm away from NWBO all says to me that they want people to manage the here and now and get this across the line but I don’t see any building blocks to take this forward as a potential big pharma wannabe
I don’t have any expectations of anything like $100m in revenue for NWBO directly but in total yes the revenue will be slightly north of $100m - Advent will be a significant recipient of this revenue as they don’t own the vaccine but are a third party contract manufacturer and can charge what they like.
Without commercial scale as a personalised vaccine DCVax won’t get approval so Advent being scaled up has a benefit to shareholders of NWBO but will in its own right become an extremely valuable entity…
Well the rules for the specials program won’t change until the NHS agrees to fund it to everyone on an equitable basis in the UK. The only thing changing in the short term is that Advent can scale the capacity up to around 40/50 per month from the specials program. Approval and pricing is agreed between the NHS and NWBO on a scale based around safety, efficacy and improvement to life and also using existing treatments costs as a benchmark. The more benefit the higher the price etc
It’s not just me that agrees with you but more importantly so does the NHS….which is why it’s allowed for self paying patients while the trial concludes and the efficacy / benefit can be measured and a price gets thrashed out.
Yes they can charge cost but not profit at all from it. It’s modest direct costs only….they are treating around 4 per month at $200k a patient - the revenue stream for NWBO is negligible until approval. It’s supplied at cost only.
Only after it’s been deemed fully safe - remember NICE cannot evaluate DCVax for efficacy until after unblinding and the company provide them the data. If it’s deemed safe then it’s perfectly reasonable and in fact a good option to patients who have zero hope….so the specials program is a very good thing. I know this first hand…trust me.
I don’t believe any of the income from self paying customers has gone to NWBO to date. I believe NWBO are unable to make a profit from the self paying patients, it’s against the rules. There is a difference between actual costs and making a profit of course but I’m not convinced NWBO will incur many costs in making a drug they don’t actually make….To that end I believe Advent as an apparently unconnected party are able to make a profit…..The situation changes when the NHS approve DCVax but until then I suspect NWBO will not see enough revenue to see them to approval….the only option being to do a big financing after TLD to minimise any dilution.