woodaldo - I have no such expectation because not even a Pharma behemoth like Roche will corner this market, it is too big. I have made this point many times on this bb. NCYT'S high-quality assay will not corner the market, but it will secure contracts and huge sales of the company's diagnostic test as well as several FDA approvals in many countries.
Some "contributors" on her have difficulty in grasping the concept of a whole-of-the-World market. As I said to one such person yesterday, the World does not begin and end with the United States!
woodaldo - the whole-of-the-World market created will enable both big and small manufacturers to take their respective share. However, NCYT'S assay is at the top of the assay table for a reason; it is an 'unmatched [diagnostic] tool.' My understanding of this is that it does not have an equal out there! The WHO and PHE have endorsed NCYT'S test, but not ThermoFisher's or Lab. Corp's offerings, as far as I am aware.
B2HS2L - I think we can safely draw that inference. I'm optimistic that our test is going to be rolled out accross the NHS for the reasons I have given in my previous posts. The CEO has said he is pleased that NCYT is doing business in its 'home market'
1. The science behind the PrimerDesign assay is solid, hence it is described as an 'unmatched [diagnostic] tool. 100% homology with Covid-19, sitting at the top of the assay table. C.E. Mark-accredited. Endorsed by the WHO, PHE & Roche. The scientists' will be working hard on a daily basis to ensure it remains locked down and as solid as a brick wall, meaning nothing can get through it.
2. The quality and strength of the assay is a major selling point which will secure contracts and sales for NCYT because it makes our diagnostic tests reliable, accurate and quick. In the current market and climate, this is exactly what buyers' want and need.
3. FDA decisions on Emergency Use Authorisation will be based upon the 'totality of the scientific evidence'. The science behind PrimerDesign's assay should withstand FDA scrutiny, leading to EUA approval both in the U.S. and other countries.
An assay is an investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte). The analyte can be a drug, biochemical substance, or cell in an organism or organic sample.
Assays have become a routine part of modern medical, environmental, pharmaceutical, and forensic technology. Assays in high commercial demand have been well investigated in research and development sectors of professional industries. They have also undergone generations of development and sophistication. In some cases, they are protected by intellectual property regulations such as patents granted for inventions.
Wolfie - I'm sure they do, but I'm going off what was in the RNS, 'GMP Pharma'! Let's hope they, (the 3rd Party,) are 'Current' and that this oversight by NCYT is just that, a small oversight. But, as I said earlier, the devil is in the detail, so let us all be detailed devils. Perhaps you and I ought to proof-read future RNS'!
9"N - Following yesterday's positive RNS and the share price increase, we didn't hear a peep out of you man. NOT A SINGLE POST ALL DAY! But today when the SP goes slightly negative you return to this bb. A coincidence? I don't think so!
I take it that when you saw yesterday's RNS at 7am, (and that would have been the time that you saw it)! you crawled back under your rock, I mean duvet?
Here is what it means:
A contract manufacturing organization (CMO), sometimes called a contract development and manufacturing organization (CDMO), is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing.
GMP-Compliant = Good Manufacturing Practice Compliant
The appointed Third Party Manufacturer in Europe may or may not be a CDMO!
B2HS2L - You make some valid points.
NCYT'S application to the FDA for EUA has fallen victim to the Agency's relaxation of its EUA requirements announced on 29th Feb. I think some clarification from NCYT would have been useful. For example, is the review and consideration of our diagnostic test being done under the 'old', pre-29th Feb system and is that the reason for the continuing delay? Paul Eros referred to the FDA'S 'prescriptive approach' to applications, including EUA ones. In view of the prevailing and urgent circumstance, could NCYT have been allowed to withdraw its original application and then resubmitted it after the FDA'S announcement of 29th Feb. Perhaps there are other reasons for the delay?
The FDA will have to make a decision on our test. In the meantime, in the absence of an RNS to the contrary, we have to assume that our test remains under review, pending a decision.
The lack of news on the application to Chinese FDA is even more confusing because the CEO inferred that it would arrive in 7 days, certainly before the U.S. FDA. Personally, I do not like loose ends or being left in limbo. I can rationalise the situation related to the US FDA, but not China, especially in the absence of a long overdue update. The CEO also tweeted that news was awaited on applications submitted for FDA EUAS in several countries.
I do not envisage any supply chain issues. The third party manufacturer appointed is a specialist and is GMP-compliant, likely to be CDMO with significant manufacturing capacity because it is a manufacturing organisation. It could almost certainly take on the full responsibility of manufacturing all of NCYT'S diagnostic tests, if necessary. I assume that it will have robust and well established supply chains as a recognised, high quality manufacturer.
Promega's presence in Southampton is interesting because NCYT also has a site there.
London Imperial College will be using state-of-the-art, statistical and mathematical modelling tools to track this virus and predict its trend. IMO the dataset generated by diagnostic testing needs to be as accurate and uniform as possible because this will inform the modelling being done by people like Neil Ferguson and his colleagues at Imperial College. This is why it would be useful to have the same diagnostic test throughout the NHS. This should, in my opinion, be an important consideration of NHS procurement managers throughout the country!
woodaldo (1030 post) I read the RNS of 12th March differently to you. I believe the manufacturing combination referred to is the combined manufacture between Novacyt's Camberley site and the third party manufacturer in Europe. In the previous RNS, 28th Feb, the CEO made the point that, if necessary, the company would bring its own, second manufacturing site (Southampton) into play. However, in the RNS on 12th March, this second site was not even mentioned. Reading between the lines therefore, it appears there was a surge in demand for our tests after the RNS of 28th Feb that went beyond the manufacturing capacities of BOTH the company's manufacturing sites at Camberley & Southampton. The company therefore decided to appoint a third party, GMP-compliant manufacturer in Europe in order to scale up the manufacture of its tests to meet the surge in demand. It looks like all of the manufacturing is being done by NCYT (at Camberley) and the unnamed, 3rd party in Europe. I would expect the 3rd party will produce the majority of the tests because I believe it is a specialist CDMO which will have a much greater manufacturing capacity than NCYT does. This is why NCYT appointed them in the first place!
For a small company like NCYT to scale up its manufacturing capacity by appointing a third party (CDMO I suspect) manufacturer is MASSIVE news and indicative of the demand in the near term and coming months. This step, together with the company's release of its revised assay (26 Feb,) are the two most important developments that the company has announced.
As I said earlier, the assay is the Golden Goose that will secure not only contracts and sales, but FDA approvals, eventually! Now that throughput and manufacturing has been scaled up, everything is in place!
Kissimee - I think the test will eventually be rolled out accross the NHS because the procurement of diagnostic tests needs to be standardised and joined up across the whole of the NHS. Using one, reliable test will make the government's strategy much more effective. Keep the data set as uniform and as simple as possible because this will help to keep track of the virus nationally. This is extremely important because this data can then inform the complex statistical and mathematical modelling that is going on in the background at places like London Imperial College.
Wolfie, you appear to have moved the goal posts on this one. Your post at 9.19 appeared to be about the route into the U.S. and not the identity of the OEM. Here is what you said, 'That's excellent news, great find Silver and we now know we have a route into the US'. I merely pointed out to you that the route into the RNS was announced weeks ago in the RNS on 28th Feb.
I'm sorry that you no longer have respect for my opinion, but the devil is in the detail so it pays to be a detailed devil.
There's a trend on this bb of people not reading or digesting properly the detail in the RNS'. At times it's frustrating.
No offence was intended, I aplogise if you were.
I'm not too concerned about it, but NCYT has withheld these details for whatever reason. The assay is the Golden Goose, and I am sure the scientists at NCYT /PrimerDesign will be working hard to maintain it every day.
I think the company's profile here in the UK will be much bigger by the end of this week. I'm optimistic that we will get name dropped by a minister here soon.
BTW thanks for the recommendations
Parkez - either way, the identity of the OEM will come out in the end. Have you any idea why NCYT has withheld their details along with those of the two Asian terrItories and the 3rd party manufacturer in Europe, apart from NDAS. Why the need for NDAS, if that is the case?
Nothing wrong about being in a minority; contrarian investors are some of the biggest winners out there. I think this comment from Warren Buffet acknowledged this. 'Be greedy when others are fearful!'