FDA Emergency Use Authorisation is an important milestone for the company and its Covid-19 diagnostic test. Further milestones are likely to be hit in the coming weeks and months because there is a pipeline of positive news.
cipro - It STATES, (it does not suggest,) that the company has successfully obtained the EU authorisation that it applied for. China FDA will quickly follow. The CEO'S previous tweet suggests that the company has lodged EUA applications in several countries. Every single one will be successful.
more than likely. I expect China FDA will follow quickly on the heels of the US FDA.
Although the epidemic in China appears to be subsiding, the market there for diagnostic tests will be an important one for NCYT in terms of future business. China like every other country will be bulk buying and stockpiling tests ahead of any further outbreaks.
Yesterday the U.S Food & Drug Agency granted an Emergency Use Authorisation to PrimerDesign's Covid-19 diagnostic test. This small, anglo-french company submitted its EUA application to the US FDA in early February 2020. The science behind the test is World-leading, hence the test has been descibed as an 'unmatched [diagnostic] tool' in the fight against the virus. NCYT'S test sits at the top of the assay table; has 100% homology with Covid-19, has a two-hour turnaround; is reliable and accurate. Moreover, it has been endorsed by the WHO, PHE and Roche. This week 8 further NHS hospital took delivery of this test, following their endorsement and recommendation by PHE. Hampshire NHS trust has been using these tests for several weeks.
So, given that NCYT is an anglo-french company and given the proven efficacy of its Covid-19 diagnostic test, why hasn't the government reassured the public by making them aware of these tests and their use in the NHS? Isn't it about time the government championed this test and this company!
The EUA authorisation issued by the US FDA yesterday will be the first of many that are issued to NCYT'S diagnostic tests. The company will be successful in obtaining every EUA authorisation that it has applied for in every country, and there are several of them, per the CEO'S tweet last month. The end result will be that NCYT'S test will obtain more FDA EUA authorisations for its tests than any other company in the world, including the big pharmas.
The company's assay is the Golden Goose and the science behind it is solid, hence the reason our test is described as 'an unmatched [diagnostic] tool'. It will withstand the scrutiny of any FDA EUA procedure in the World no matter how rigourous and prescriptive. We've now got the important one, now for the rest of them.
Minus, as you acknowledged earlier in the week, this share is no longer easy to trade.
The arrival of this virus and the resultant, exponential increase in the company's sale of high quality diagnostic tests, generating additional income to NCYT'S core business, coming so soon after the restructuring and consolidation, is a company maker. I think that we can reasonably expect this purple patch to continue up to and beyond the release of the annual results at the end of next month.
Given your interest in pharmas, I suspect that you know exactly where this is going, debt and the presence of the big pharmas in the market notwithstanding!
Yuri - applying normal metrics to this one is not something I'm too concerned about.
I'm sure procurement and resource allocation is under control, as evidenced by the company's graduated and flexible approach to increasing it's manufacturing capacity to meet the demand for its diagnostic tests. This tells me that NCYT is being run well. I do not believe that any of the tests produced will be going to waste!
As for the temporary higher demand, I concur with the CEO'S assessment and prediction that the current demand will stretch to several months. There is nothing temporary about Covid-19, now its been identified this virus will always be with us. After this initial outbreak subsides, countries will stockpile tests in readiness for the next outbreak. Let's hope that unlike H1N1 - Swine Flu - there is a significant hiatus between this current outbreak and the next one.
You may not be aware, but immediately before this outbreak the company was restructured at the end of 2019, resulting in greater consolidation. This has proved to be both prescient and timely!
And here's why;
RNS 12th March - On sales .... 'this represents approximately five months of sales for the division under normal circumstances.
RNS 16th March - On sales.... 'this represents approximately eight months of sales for the division under normal circumstances.
RNS 20th March - On sales .... 'this represents approximately 18 months of total sales for the division under normal circumstances and already exceeds the total sales achieved by Primerdesign in 2019.'
This is all additional revenue to the core Novacyt business!
CEO has confirmed what he put out yesterday in his interview with Radio 5 Live; NCYT has gone into OVERDRIVE. It is obvious that the company is going to continue selling many millions of its tests for many months if not years to come. The nature and extent of this first outbreak, coupled with the fear factor, will ensure that once it subsides countries will begin stockpiling diagnostic tests in readiness for a second outbreak in the future. They will want to be better prepared next time around.
Not sure how Public Health England an executive agency of the Department of Health and Social Care here in the U.K. could take over a public limited company such as Novacyt. Neither feasible or necessary. Given that our tests successfully went through PHE'S formal evaluation process, providing the feedback from the 8 hospitals is good, then we might see a greater uptake of our tests by the NHS in the coming days & weeks.
Hopefully, our supply of tests to the NHS will gain traction now that we have a foot in the door.
Graham Mullis in his interview with Radio 5 live yesterday confirmed that NCYT is selling significant volumes [of tests] throughout the World. Over 60 countries, now likely to have increased!
This is because the CDC backed itself and believed it had everything under control with the development of its first diagnostic test approved by the FDA on 4th Feb. However, this test proved to be unreliable. This left the U.S. effectively without a test for almost the whole of February. The real irony is that NCYT'S test, which has been sitting at the top of the assay table for weeks, has also been sitting in the U.S. for weeks from early February, waiting for FDA EUA approval.
Common sense should have told the CDC in February that the US needed a test urgently as a stopgap until the problem with its own test had been remedied. The CDC should have taken delivery of the WHO test, that is the one sitting in 3rd place in the assay table. Unbelievable!
Wolfiebill, spot on. Based on 'the totality of the scientific evidence', otherwise their credibility would be shot to pieces and their approvals would be worthless.
NCYT'S application was submitted around the time that the agency authorised the CDC'S test on 4th Feb. As we know our application had been under review for approx. 3 weeks when the FDA on 29th Feb relaxed its own requirements for emergency use authorisation in order to deal with the increased number of such requests as a result of Covid-19. The FDA'S EUA procedure simply could not cope with this type of emergency. Post - Covid 19 it will be reviewed, revised and modernised. It looks to me like our application is still being considered under the 'old system' pre-29th Feb which is prescriptive and rigourous. This has not worked to NCYT'S advantage. However, I am confident that NCYT'S will achieve FDA EUA approval because the science behind the test is undeniably solid. The updated assay table released yesterday shows PrimerD's test still sitting on top of the table.