Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
Although I find the fact that either the Primary or Trial completion date being wrong (as per the NIH trial protocol) frustrating, not even to mention my frustration with Consilium for ignoring two emails of mine stating the fact, some ‘interesting’ thoughts have sprung to mind while thinking about the dates.
Should the STUDY completion date be correct, stated as 01 Oct 2021, recruitment should be completed at around the beginning of Jul with the Top Line Data readout at the beginning of Sep. This seems unlikely based on the update given during the AGM.
Should the PRIMARY completion date be correct, stated as 01 Oct 2021, then recruitment should be completed at the end of Aug with Top Line Data reading out beginning of Nov. This however poses a potential commercialisation issue.
The Northern hemisphere’s wintery period starts around Nov which would result in an increase in infections due to the seasonal nature of covid. Hospitals should ideally already be stocked or stocking on treatments. If results are only released beginning Nov and provided they’re good, orders will follow and ultimately manufacturing meaning SNG001 will most probably be reaching hospital stock rooms by the end of Dec or Jan. Potentially later. This could be a 'major' commercial setback and something I trust (or hope) RM is thinking of.
I’m highly confident an interim efficacy based analysis is planned by Synairgen, if not already performed or under way, which would represent a large enough cohort of patients to achieve statistical significance providing them with a mandate to ‘proceed with’ or ‘terminate’ the trial. It’s too an expensive a trial across too many countries for a small company not to have such a check point.
From what we know the major markets for SNG001 will be the US, UK and EU and these are also the regions where recruitment are either complete or in their final stages. An interim analysis will be based on data from these regions.
So the question is: Assuming SNG001 is successful will we see an EUA application for the US, UK and EU to ensure orders can be fulfilled and shipped to hospitals prior to winter therefore maximising revenue generation?
The same concern applies to ACTIV-2. Assuming we progress to phase III, the trial will not be completed until late this year. If pre-hospitalisation treatment is a high priority could we see an EUA application based on the combined evidence produced by SG016 and interim SG018 supporting treatment for patients with marked or severe breathlessness in the home environment?
I’m not aiming to justify or predict that we will see an EUA. I’m purely considering the effect of 'time' and how to mitigate its potential adverse effects on commercialisation.
BTW, I listened to the AGM again and based on RM’s comments I deduced that they were asked by some Regulator/Government to test SNG001’s efficacy against the Alpha and Beta variants.
https://www.synairgen.com/contact-us/employment-opportunities/
The role: A new opportunity has arisen within the company for a permanent, experienced Head of Communications, who will be responsible for developing Synairgen’s internal and external communications strategy and managing execution in order to position SNG001 as a potential, near-term, valuable, COVID treatment, maximising its commercial success. This is a very exciting time for a fast growing company, and this role will be key role in the company.
The role holder will be responsible for positioning Synairgen as a thought leader in severe respiratory viral infection treatment. Outreach will focus on US, UK & European markets, creating and maintaining connections with PR, IR & PA companies, HCPs, Government and the Pharmaceutical Industry.
It could be that what he actually meant was that they have commenced with phase III recruitment even though SNG001 is still in phase II.
Here's why. Infused agents are allowed to commence with phase III recruitment prior to meeting the graduation criteria which is based on day 28 data of all 220 patients, provided the interim analysis which is based on 110 patients support such a move. SNG001 is an non-infused agent and the current published protocol does not allow for such a move. But, it is possible that an updated version of the protocol, although not yet published, does allow the same continuous recruitment for non-infused agents. Should that be the case then it is possible that they're already recruiting phase III patients for SNG001.
However, that does not necessarily mean that SNG001 will progress as it still has to pass the final graduation criteria.
My bad. Sorry.
That is the CUMULATIVE total to date. Total new admissions for the past seven days up to and including 12 Jun 2021 is 1,000 for England.
http://ctri.nic.in/Clinicaltrials/advancesearchmain.php
Use SNG001 as the 'keyword' and then click on 'View' once the summary page pops up.
Until the covid-19 patent is granted there is no real legal procedure, if any, available to Synairgen. Once granted they can under UK & US law claim retrospective damages should the patent have been infringed upon during the ‘pending’ phase. Not sure how the EU works. We can only hope that the patent is granted asap, especially in our key markets.
What we don’t know is how specific the covid-19 patent is with regards to the definition of interferon beta or under which circumstances treatment are prescribed.
Skeletor - Mexico & Germany are still to approve. I suspect Argentina has approved as I found an excel document listing covid-19 trial approvals last month, but it’s no longer available online.
All sites in India have approved except for one. Hopefully that’ll come through this week and not lead to further delays.
It could just be a random publication of the case study. I remember Richard participating in a symposium back in Feb which focused on clinical trial designs.
https://www.nihr.ac.uk/events/virtual-symposium-delivering-complex-and-innovative-design-cid-studies/26298
I've sent an email to Consilium about the Primary and Study Completion Dates asking them to confirm which is correct and to have Synairgen correcting the protocol. Hopefully we'll get clarification soon.
It's either one of these two scenarios:
Scenario 1:
Last Recruitment Date: 03 Jul 2021
Primary Completion Date: 31 Jul 2021
Study Completion Date: 01 Oct 2021
Top line results: Beginning Sep (assuming four weeks for analysis)
Scenario 2:
Last Recruitment Date: 03 Sep 2021
Primary Completion Date: 01 Oct 2021
Study Completion Date: 02 Dec 2021
Top line results: Beginning Nov (assuming four weeks for analysis)
Updated version of phase III (SG018) protocol published, however one of the completion dates are wrong. Which one is wrong & which one is correct?
Both the Estimated Primary Completion and Study Conpletion dates are 01 Oct 2021. The former used to 01 Jun 2021 and the latter 01 Sep 2021.
40 trial sites listed across eight countries.
https://clinicaltrials.gov/ct2/show/NCT04732949
The whole argument is based on a false narrative. The global pharma industry, irrespective of whether individual companies are competitors, are cooperating & assisting each other. The EU for example is backing investment in production facilities in Africa which they say is better than waiving patents.
Of course China & Russia would agree. Perfect opportunity to legally get their hands on Western technology.
I do find it ironic that both India & SA have significant production capacity and will be producing, yet they came up with this idea. SA will have capacity to produce 200m J&J annually.
https://www.google.co.uk/amp/s/amp.ft.com/content/d2a47c7e-0b00-4e31-92ab-cd3ff0b9070b
This does pose a potential risk to us of which the extend will only be known in the future, even though the focus is on vaccine patents. It would be wrong to just simply ignore it, although I think it's a small risk. You can only hope that common sense and informed reason will be upheld by those countries opposing waiving patents. It is not the right or best solution to a perceived problem which may not even exist. According to an article published in Nature it can be deduced that sufficient annual production capacity would exist to manufacture enough vaccines for 70% of the world's population, based on two shots each. 70% require 11bn shots. It could even be achieved this year based on some predictions, provided no major hiccups although I'd say it's unlikely.
What has NOT been factored in, in this argument is that annual booster shots will only comprise of one shot and not two. So that brings annual demand down by 50%. Therefore it's plausible to predict that by 2022 annual supply would outstrip demand provided that the science on booster shots remains unchanged with regards to receiving only one shot.
https://www.nature.com/articles/d41586-021-00727-3
xviolet - stop trying to seek attention. Secondly my post states approval of the phase III trial and NOT approval of the drug!
Argentina seems to have approved SG018 based on this Buenos Aires government website/link. Only one trial site.
Refer to row 604.
https://www.buenosaires.gob.ar/sites/gcaba/files/registro_caba_covid-19_web_cce_4_mayo_2021.xlsx
Argentina's official trial register has not been updated since 12 Apr, but found this in the meantime.
According to Simply Wall Street the three biggest shareholders hold 8.9%, 5.6% and 5%. We know Polar has 8.9% and Polygon has 5%. Who could be the 5.6% unless it’s an incorrect statistic. Anyone has access to Morning Star’s latest holdings stats? It further states that the biggest 16 shareholders (Institutional Investors) hold 51% of shares.
https://simplywall.st/stocks/gb/pharmaceuticals-biotech/aim-sng/synairgen-shares/news/what-is-the-ownership-structure-like-for-synairgen-plc-lonsn
None of them really do. They’re updated periodically and even incorrectly sometimes. Frustrating.
The individual sites are still listed as inactive. Could just be an update issue.
Correct
Thanks Peelweight - that makes sense.
Mikep109 - I just checked and the master protocol from 22 Feb already stated this exclusion. Any changes to the protocol published as part of the clinical trial register need to be carefully interpreted.
Page 227 of the master protocol
4.1.2 Exclusion Criteria
4.1.2.11 Use of or need for chronic supplemental oxygen
https://fnih.org/our-programs/activ/therapeutics