The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
In essence, we are both right but from different perspectives, and i would never disrespect Lovelyboy's opinion.
I would bring to your attention though, the issue of the FTO (Freedom to Operate) which is different to patent searches in that an FTO refers to whether it is commercially "safe" for a company to make or sell products in target countries without infringing existing third party patents or other intellectual property rights.
At the time of initial patent filing, it was unclear to Cizzle what the commercial format would be, and due to the complexity and costs involved, it was decided that the merits of conducting a FTO would only be considered after design, manufacture and components had been resolved.
The directors believe that it is reasonable to rely on the legal due diligence it has carried out to date.
"Furthermore, the group intends to contract out manufacture, and would seek protection within the supply agreement that the manufacturer will warrant that it's design and product will not infringe third party intellectual property.
The group is not aware of any claims of infringement related to it's intellectual property, or potential product designs.
Since the core patents have now been granted and published, and no oppositions or relevant prior art have prevented validity of the patents, it provides comfort that third parties will not provide subsequent oppositions which in any event are time limited and now likely to have expired."
Neil
Evening OAPK20,
My opinion only, but personally i think there is ABSOLUTELY NO CHANCE that CIZ will wait for grant of the patent, for a number of reasons:
The patent is only for the claim of use of a fibrinogen capture agent and not the previous claims submitted in application for the protection of the use of the technology as a whole.
The patent is not for the physical manufacture of the kit.
If Ciz waited for grant on patents every time they made an application, we would be YEARS away from a product, as effectively, we would have to start over every time we made an improvement/change in the kit.
If we had waited, then we would not have spent the amount of money we have already spent on development of the kit.
You don't spend that amount of money on a patent without knowing the end product would be manufactured. The patent is protection of the intellectual property of that invention.
You don't sign marketing agreements with companies in the hope that you may get a patent.
I have personally submitted a patent application on a piece of equipment that i developed in my company. The equipment was manufactured long before the application, as i needed to know that what i was making was fit for purpose, met the technical requirements of my particular industry, met safety requirements, and a number of other industry specific requirements. Without giving too much away, my company supplies these items to one of the biggest blue chip companies in the UK. The company has interests in UK and USA, and they are MORE THAN £10,000 EACH
This is my reasoning behind the first line of this post.
Hope this put your concerns to rest.
Neil
Techtonic,
Sorry but this reply is likely to be a long one....
The references to Clinical trials can be confusing. We have already conducted numerous clinical trials on our technology, hence we know it works. I posted some time back (a year or more) about trials having taken place. This is where references have been made to utilising retrospective data on our application as an LDT. This retrospective data has to be validated on the JESS platform
In respect of this mention of clinical trials, it is meant as being able to put the test into the market. In doing so, it is not just a case of a trial, and that's it, it has a lifetime cycle.
It will be done in exactly the same way that Galleri is doing in the NHS. i.e although they supplying to NHS, it is still a clinical trial. - No different to us, so i think you are reading it from the wrong perspective.
Patent - no, it does not in any way progressing. The patent simply protects our product from infringement by others.
Can't see why it won't be granted, but it does happen. In our case, we already have previosu patents granted worldwide. This is a technical extension of those patents.
Yes, there is nothing to stop us moving on whilst the patent is pending. Hence why we have got so far while it is pending.
Patent re commercialization - we don't need to wait for the patent to commercialize, and no major jeopardy as we have all the previous patents on the technology.
Near term - My opinion is Allan expected to be giving news out before now, and he himself has said in interviews "very near future" My opinion is still that something will be announce by end March.
Drip feeding information - again goes back to comments by Allan about only putting out SIGNIFICANT news - there will always be traders happy with a 10% rise, and sell into it. The least number of time we get a mini spike, the better. The ones to reward are the shareholders that support the company long term, not someone in today for a quick £100 or so.
Your last line feeds back into the first answer. Clinical trials is an ongoing process.
Nothing in there that i have any concerns about.
Hope this helps.
Nei
Morning OAPK20
The application is definitely priority status.
regarding date of grant, it's hard to state any specific date with any application, as a patent is granted (- mainly - ) subject to the claims it contains, and any challenges to those claims. Those challenges being from other parties that may be looking at similar implementation of their product.
Since this patent is specifically focused on the use of a fibrinogen agent to capture the CIZ1B protein, i don't foresee many, if any, challenges, as it is so specific in it's boundaries. i.e. specifically with CIZ1B, and not just a general unnamed protein, where there would be grounds for a challenge, as the claim is too loose to be included.
So in answer to your question, honest opinion, is it SHOULD be around March time, but there may be other factors involved.
Neil
Evening Techtonic
Confidence is high. Every day that passes is another day nearer to long awaited news
There seems to be a number of events which are significant in their own rights, that are just building up -
LDT progress, readiness for clinical trials, commercialization, "the next product", LFT development, etc are just ones that we know about.
The question is, as they are all backing up, will it be a number of smaller RNS's, or one blockbuster?
We know Allan will not issue RNS's unless there is something significant to tell the market, but either way, there has got to be a point in the very near timeframe where the gates open, and news flow follows.
Neil
Hi OAKP20
Yes it is priority application as it is basically an extension to previous patents already granted in respect of the technology.
The date is correct as you surmised.
It doesn't rely on any commercialization or approvals etc, as the patent is granted on how the technology CIZ have developed is implemented. Hence why previous patents have been granted in the absence of the test kit.
Neil
Hi Techtonic
It's a shame that posts can't be edited, as it would be a lot easier for me to respond under each line of your post, so ill try and answer then in order as they appear.
lines 1, 2, and 3 The reference to Biotechne wasn't meant to infer that all these investors are buying in because of CIZ, it was meant to convey their confidence in Biotechne, as an expanding co. which is actively looking at mergers/takeovers, and given our involvement with them could be seen as a positive for us.
The subject of the dividend is in the same report, so i knew about that.
line 4. I hope you don't have reason to doubt my ability to demonstrate my discernment in my investment strategy.However i have always said no one should place any trust in their decision to invest, on my posting here. At the end of the day, you don't know me from Adam, and there are too many "investors" on these boards for the wrong reason. All i can promise, is that i am nor one of them. I do note that on recent posts, i have omitted to add the line about not relying on my information, so for that, i apologise.
line 5. Ties in a bit to line 4 and should not be relied upon. If anyone says they are 100% on all their investments, they are lying. NO-ONE is 100% - not even Warren Buffet will claim that. have i made some losses? yes, but in my terms not large ones. Have i made some good returns? yes. Have i made any spectacular returns? yes. 2. But that is all relative. What i detemine as "small" may be very large to some, so you can't really base success on that basis, as it is relative to each individual.
Line 6. Again, ties in with line 5. I do in general agree with your comment. Those admittedly, sometimes very plausible people, usually try to hammer home a figure. eg. 10p by Friday/ £1 by end of year etc. You will note that i have not, and will not ever specify a share price. I will not give anyone false hope/expectation.
re confirmation bias - As you should have deduced, i have a VERY substantial holding. Without wishing to sound condescending or up my own ar5e, can i afford to lose that amount of money? yes i can,. so the issue of having a heavier bias is not relevent.
Line 7.Since i am not religious in the slightest, my "unwavering " comment is based purely on my research.
Line 8. No i am not keeping a slightly open mind. My mind is COMPLETELY open. I want to know as much as i can about my investment, including any possible drawbacks, issues, concerns etc and if i find them i will find out everything i can. I have raised some concerns with the company, and had them responded to, and am happy with the response. Whenever needed, i have gone to independent sources to verify any concerns i may have had, and received responses to varying degrees depending on what they were able to divulge.
Hope this helps.
Remember though.....don't base your decisions on anything i post!!!!
Neil
Some big institutional investors know something?
Report released today shows who's increasing their stake in BioTechne.
Here are a few -
Investor increase in holdings % stake now held $
Select Equity Group 382.9% $592,919,000
Morgan Stanley 1, 300.4 % $247,200,000
William Blair Investment new holder $188,929,000
Norges Bank new holder $136,489,000
Mackenzie Financial Corp new holder $146,458,000
Institutions and hedge funds own 94.64% of the company's stock!
Neil
Hi Techtonic,
Sorry i am just responding, but not been home from work for long.
Yes i have been in communication recently.
My opinion is that a significant RNS will be lodged before long followed by an interview (Stockbox or Directors talk would be my guess) in which Allan will update us on what the RNS entails, and possibly news on further developments.
I'm not saying it is a definite, but i think on a significant RNS, there would be an opportune moment for a live Q&A session as we have had previously.
Last week Allan was "travelling" - see Greend100 post. - Wonder where he was travelling to /from?
re your last paragraph........ i have been in contact with with the company even before it became Cizzle Biotech, If you look back at my first ever posts, you will see my involvement. You may also find later posts in which i advised this bb about certain professionals i have been in communication with, and how i can guarantee that NHS are aware of us.
They will not tell me any more than they are allowed to, but i like to think that i have a bit of a handle on how to read what / how they are communicating. Hence my unwavering belief, and the reason for my VERY substantial investment.
PS, also not far from York
Neil
And in a further bit of news that could see Cizzle test being more urgently required by NHS.
If you have been following the saga of Illumina / Grail anti-trust case, it seems that Illumina have finally accepted defeat, and will unwind the merger ordered by the European Courts of Justice, & US Fifth Circuit Court of Appeals.
They announced Dec 17 2023, that Grail will be sold off by end of Q2 2024
Given that Illumina put up a significant investment in Galleri trial, it's not looking too good.
Neil
Although i hold investments in a number of companies, i really only post on this board as it is by far the best in my opinion. There are some really toxic childish exchanges on the majority of them, si i don't bother.
CIZ is a friendly, helpful and informative forum, by people that i believe are here for the right reasons. For me, it is just to try and help fellow investors to understand their investment, and hope you make some money.
It doesn't cost anything (okay sometimes a few quid for subscriptions to get information , and time etc) and i would really like to see it remain, so please can we try and keep it that way.
Okay, so as to why the perceived delay in any news, in my opinion, i don't see there is anything wrong. What i do believe, is that we are at a critical stage now, and that stage is where everything needs to amalgamate in order to release news.
By that, i mean that we were at research levels of Mabs, reagents etc, and needed to massively increase those levels to a commercial level. That takes time. Allan said that these will be the ones used for commercial launch in conjunction with BioTechne JESS platform, and need to be validated in terms of storage, shelf life, stability, batch and quality control etc and how they are distributed. We are not just putting this test into the local Boots pharmacy, we need to ensure they will survive being distributed across the world.
In tandem with this, is the work going on to receive reimbursement codes so that we can sell the test, and receive payment.
We can't do a product launch without all these processes coming together. Imagine a couple of scenarios..... we launch the test, but then find we don't have enough compounds - disaster.!, Or we get enough compounds and launch in USA, then find we haven't been granted reimbursement codes, so we can't apply for payment - disaster!
I for one (as frustrating as the wait is) want them to get everything right, and get this into market with no issues.
Just as a note on the discussions on sensitivity, even IF (it won't be) sensitivity is 75% as has been mentioned, it will not be seen as poor, because at the very least, it will still be far better than anything out there.
THere is also the possibility that it may be slightly better than the 95% mentioned. The reason i say this, is because during the process of manual transfer from pipette to the Jess cell, is where errors are made.
In our case, our platform is fully automated, and will reduce the incidence of errors.
I don't think it will be long before we get news, and an interview with Allan, and a further news flow thereafter.
Neil
OAPK20,
No, the CAP accreditation is held by the laboratory developing the test.
Techtonic,
All questions are highly relevant, and good that people ask them rather than not questioning, but for the reasons i posted, i don't believe that we will have much, if anything to worry about.
As Brondy also touched on, we have Dawn Coverley with 20 years of extensive research on this, and with Corepath and Biotechne behind us, with their contacts, expertise, partners in US, and previous experience, that just adds more credence to us.
The whole issue with the lobbyists is to protect their interest. The issue with FDA is the evidence in what is being claimed in test results. Our test results, validation, etc will, i believe stand up to any scrutiny.
OBD's issues are not the same, although in my opinion, because of the disaster of an RNS and it's claims on slaes (that appear to have been misleading) this is a convenient thing to try and pass the blame onto.
Neil
Morning VincentVega
This has been raised over and over by certain groups lobbying the FDA and they are still no further forward.
As Brondby says it will be years if we see any effect.
One thing in our favour is the fact that Corepath are CLIA , and CAP accredited.
The other thing is that our test will be listed in the class 11b device under IVD list B product, so deemed low to medium risk, and not subject to the more stringent requirements of other class devices.
Even IF the lobbyists do get an ammendment, it will likely be 4 years minimum from the date of final publication (add probably another year for that) and FDA reckon it will take 3 years to get staff in place to oversee the regulations, so i personally don't see it affecting us.
On another note, a comment by someone the other day mentioned Bill Behnke being on the payroll. Just to clarify he isn't on the payroll, but we have an agreement where he and the Behnke group are responsible for the marketing of our products in USA.
In a great bit of business sense, Cizzle entered into an agreement where Behnke group will be paid ON RESULTS. Love that for an incentive.
Incidentally it was Bill that introduced us to Corepath, and with who Behnke group have many customers.
Lovelyboy, if you are looking in, have a look at OBD webinar that VV posted today......and you wasn't sure if i was pulling your leg when i mentioned about the size of the vetinary market :-)
Neil
Evening OAPK20
Effectively, that is exactly what we have.
Once we have clearance in USA, a route to China market.
The agreement with China is 10% royalty on our kit, in addition to the supply of the reagents / antibodies, and any other use of the technology.
It makes perfect sense to utilise Jess, since that IS the platform on which our test is validated. In my mind, there must be some agreement following, whereby Cizzle says to Biotechne " we are promoting your hardware, so will licence our proven technology to you to offer a turnkey package. All proven, and cleared/approved"
But then that makes it a worldwide market, since Biotechne will be keen to say to their customers throughout the WORLD "here you go - a ready made package with unrivalled accuracy / sensitivity, with their machine being the key.
That in itself is a hell of a potential, but when you then factor in that we have developed a library of biomarkers to detect other cancers, and we already know that breast cancer test kit is being developed now, it starts to get really interesting for both us and Biotechne.
If that wasn't enough..... remember the line "accelerate our development of a lateral flow test"
So many facets to the potential here, it is hard to get your head around it.
Neil
Neil