Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
JAdam - could you ask him what the strategy is for the roll out of what effectively is a companion biomarker test to the vaccine? From the response he provided you it sounds like it's a 'go it alone' strategy and doesn't have the collaborative agreement of Oxford/AZ. The big question is - IF the AZ vaccine is also 95% effective (like the other vaccines to date), why would you need an antibody test to show you've generated an immune response?
I could see a use case if the durability of response in the longer term is variable, and use of such a test could guide booster administration, such an approach would require validation.
Not deramping as I'm long on this largely because I think for the next year at least there is still a need for a good, reliable validated antibody test and this seems to fit the bill.
I'm with you scinv, I'm not comfortable with RM being listed as second author and don't know how that sits with ICMJE standards, it lessens the credibility of the scientific team working on the publication.
But, at least the publication is out now and the data are not dissimilar to that seen in the summer update. At one point, there was a mass debate on whether the primary was reported correctly, it has and the data have been peer reviewed.
Gkb -that’s why you have a placebo group!
For the other question about not having a full representation of patients in the study, that’s normal. If you’re immunocompromised eg cancer patient on chemotherapy, you can’t invoke the same immune response as someone in the general population. You need that immune response for the vaccine to work. Most immunocompromised patients are excluded from these sorts of trials. That’s why you’ll need effective antibody treatments and probably sng001 for patients who will not be able to take the vaccine.
Strikes of a plot with all platforms down whilst major plays going on. Funny how a day where science wins, but the science stocks got a thumping. Feel quite sick about it. We'll have to go through the same again when the next vaccine announces results soon, and it will likely be positive again! People need to understand that vaccines, testing and treatment will get us out of this, not just one strand. Unfortunately there is too much money to be made on other stocks in this volatile market.
Sensible RNS, good progress on the RTC manufacture and output.
Balanced update on the antigen test with realistic timelines given. I’d prefer that to some of the BS timelines that have been given elsewhere for other products. And good that the company is investigating upscaling manufacture for the antigen test, when it arrives.
This is a normal part of the process, EC/IRBs will be involved as part of the process in as much as the MHRA. The MHRA have already indicated they would be open to reviewing if not approving a challenge study. The key question is how to do it and OO have a lot of experience in this area. The objective is to minimise risk and so they will start with low doses of virus and escalate from there. They will choose young healthy volunteers who are at lowest risk of suffering complications, they will dose each patient sequentially, they will have remdesivir,dexamethasone on standby and probably by early 2021 other rescue remedies like the neutralising antibodies.
As the topic has been extensively discussed from an ethical standpoint in the public, we know the risks and mitigation factors as well as the obvious benefits. I would expect EC approval as well as MHRA. They'll be using these next few months to get the protocol right.
Great RNS, very positive endorsement of the challenge study as part of vaccine development. MHRA approval of any subsequent protocol is likely given their previous comments on supporting challenge studies.
These first studies are characterisations studies and so I wonder if/how the characterisation studies will be tied in with future challenge studies of any vaccine candidate? A question for the conf call on Thursday for sure. Of the 100 or so vaccine manufacturers still in development behind these late stage candidates (AZ/Pfizer), many will now see this as a legitimate way of accelerating their own development timelines. GLA.
Telegraph reporting 20 million of the 15 mins tests secured.
Innova mentioned. £15 per test, np and op currently but saliva is mentioned as their next development.
https://www.telegraph.co.uk/news/2020/10/19/government-secures-20-million-covid-quick-testing-kits/?WT.mc_id=tmgliveapp_iosshare_AwG1NfzGTZLV
Click bait from the ST. JVT would only know of the results of the AZ vaccine trial if he was on the independent monitoring board and he isn’t, a clear conflict of interests if he was.
We will hear of the Pfizer vaccine efficacy results before the end of this month and safety results next month. With all being well, Pfizer will file for EUA next month. AZ is further behind, due to the recent holds placed on their pivotal. AZ will probably reveal their interims in December.
Remember, these are interim results, not final. They’re enough to get the vaccines over the line for EUA or conditional approval. The vaccines are aiming for good efficacy, Pfizer at 70% for their first interim and AZ about 50%. I’ve seen nonsense on this BB yesterday that vaccines are aiming for 30% efficacy. The vaccines will need 50% effective min, in order to be worthwhile for national campaigns.
Rollout will be done by risk group, and manufacturing capacity and storage conditions will slow uptake (not to mention the antivax lobby).
I want to see the vaccines do well, humanity needs it, people here shouldn’t worry about the SNG investment. The vaccines are not the panacea, they are not 100% effective, not everyone will want to be vaccinated, it will take years to vaccinate populations and unfortunately this disease is still deadly in the meantime. Further treatments and tests will still be required. GLA.
It reads like the avacta test. Pregnancy style, mouth swab saliva, results in 15 mins. Pilots in schools beginning next week and millions of tests already purchased by the govt.
Why do the reporters only ever mention oxford nanopore in these articles?
FYI, Chembio have posted for an EUA for their rapid dx. Uses an NP and delivers results in 20 mins. They'll do well in the US, with office based clinicians/pharmacy outlets etc. Be interesting to see if they get the EUA and how quickly the FDA respond. No further technical details available.
http://www.globenewswire.com/news-release/2020/10/15/2109605/0/en/Chembio-Diagnostics-Submits-EUA-Application-for-DPP-SARS-CoV-2-Antigen-Test-System.html
The prof has a brilliant style of explaining what is a very complex process so simply.
Don't expect any minutes soon. BTW, PRIME can be designated outside of CHMP meetings. I don't think PRIME will be designated, in some ways it's more of a pain to have PRIME, as it is a rigid pathway where regulators expect certain requirements to be met, otherwise the designation can be removed. It's also too early for such a designation. I would prefer to see the adaptive pathway used. Similar to what we have seen with the vaccine submissions i.e. a rolling submission based on available data. This is more flexible and offers a higher chance of success, it also allows for rapid review. Any talk of approval is just delusional at this stage, maybe conditional once some results from Phase 3 are available.
The EMA talks are delinked with the MAP discussions, which are done at a national level. CHMP can provide endorsement of compassionate usage on an EU level, but this status does not negate the need for national level approvals of the MAP anyway. For those who missed my earlier posts: any doctor in the UK can order SNG-001 via MAP right now, MHRA just need to be informed of this use, in France you have the nATU, which, similar to compassionate use in the UK is single patient request, and goes via the ANSM first and then to clinigen. This again can happen at anytime now. The bigger deal is cATU, and I expect the protocol for cATU has been submitted to ANSM already and expect a response next month. In Germany, an application to BfArM is made, this can turn around in as early as 14 days, but expect 28 days, so expect patients in Germany being able access therapy early next month. All of these pathways can be confusing but I hope this helps to clear a few things up.
Cheers
RTB
it is more complicated but the pay off is unquestionable
1) Speed - easier to recruit 900 patients in multiple countries where incidence is high
2) Validity - easier to demonstrate that site selection bias did was not a major factor in any impending results
3) Legal - some countries need data in subjects of their country to proceed with filing
The more I re-read the RNS about the Phase 3 study, the more I like it.
Was there a trial for long Covid with SNG-001?
@philgekko. I agree, we won’t know what happened re: negotiations. However, in the midst of a crisis how much would you think is fair value for a buy out of a company with one positive phase 2 in 50 patients? Looking at it from a buyers side, this is still a high risk investment. I won’t comment on the governments position
Overall, the strategy is a really positive one. Firstly MAP is the right call, it enables those in most need access and enables wider usage. The phase 3 is a blinder. Parexel are well versed, it’s multicentre and will only take about 3-6 months to complete based on expected incidence in the next 6 months. Imagine how much it will be worth in 6 months time.
I’d like to see the phase 3 protocol published in the way that has been done for the vaccine trials. It will take the guess work out. We still don’t know if there will be differences in terms of patient populations vs phase 2.
The two dosage arms are interesting and suggests there will be interims to potentially enable early stoppages if good/bad results are seen.
Standard of care won’t be an issue in most sites, it will be fairly homogenous and remdesivir is a non issue. One can easily stratify for those on/not on remdesivir or even run a sub study. But the biggest problem with remdesivir is that it’s just not available for the masses, and takes 6 months to manufacture.
I think it will be a great phase 3, I’m glad the fda have accepted the idea of one phase 3 trial only and will accept the existing phase 2 as part of the pivotal data for filing, it’s what I predicted a while back, but you never know how practical the regulatory bodies will be.
Supply will be the key issue. What we will end up seeing is much greater demand for the MAP and there will need to be sufficient drug for all programmes. I’m glad to see this has finally been addressed in the RNS. More good news to come!
Newbie - depends on your investment strategy. I'm invested in all 3. COVID is not going anywhere quickly. It's a global phenomenon. Mass testing will be required in the immediate and certainly the mid term (and possibly longer). Whilst the share price fluctuates a lot in the short term for all 3 stocks, the demand for their products will be strong for the next few years at least.
DYOR in terms of company strengths, but NCYT has product, is making money, and has plenty of govt contracts and is investing in new offerings. ODX is leading with an antibody test as part of the UKRTC, and will follow up with an antigen test, but nothing launched yet. AVCT has a BAMS test and will soon product a saliva based rapid test for home use (antigen), which, if it works, will lead to exponential growth, but again, apart from the soon to be launched BAMS test (which is for research purposes only), doesn't have any live products. There are other potential revenue streams for all the companies. Worth reading up on, but I see all as good investments for different reasons - good luck!
Great, thanks Matml, good to know it's all coverd off.
Thanks for the reply Bella6532.
My question was more to do with manufacturing capacity. Typically, and especially if cash flow is an issue then stocks will be held for an 'as needed' basis. The need was previously only for the clinical trials, a limited number for Phase II. There will be a Phase III (my prediction) and thousands of doses will be required for this.
The MAP is now opening in many EU countries and the UK. The pressure for doses this year was really my concern. The UK can order a dose today, the Human Medicines Regulations 2012 allow for this, and that brings me onto my second question. If the final drug product is manufactured in the UK, then supply is immediate. So, UK will see usage first, if Clinigen are set up, then it could even happen today. Then likely France with requests through the nATU (here doctors will make a request to ANSM, who, if they approve will send to clinigen, who then approve (if appropriate) and then the drug is imported from it's manufacturing site (UK?). So, expect the first drug to hit France in late Oct. Germany (as per my earlier post) will get approval likely end Oct from BfArM, and then after individual cases are approved, and minimal importation requirements, expect to see first drug use in Germany in Nov. When cATU starts later in the year, expect it to really take off, similar case with EAMS.
As the winter will see increased demand for product and supply for the clinical trials will be protected, my question was really about whether there is capacity to deal with the expected demand in the next few months before the uptick in supply in 2021. BTW, don't worry about brexit and drug importation from/to the UK, it's not an issue now. Post Jan, I understand there has been an agreement for drug supplies to be protected.