George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
This is brilliant. Thx Joey.
Results as expected based on how IFN works, however delta being more sensitive is the brilliant bit.
Kevinl1977 - your question is better suited for Matml74, JoeyDiamond and the likes. I’m not the best person to address these type of questions to. I know enough to satisfy my own needs, but not to provide a scientific opinion to others.
It was interferon alpha and not beta which was used in China.
It was one of the respiratory viruses found in the COPD trial.
https://www.lse.co.uk/rns/SNG/positive-interim-analysis-of-sng001-in-copd-s44g2t8zjy1v2vc.html
SG018’s protocol was amended to include vaccinated. If I had to guess I think the amendment was made after the first 150, give or take, patients were recruited.
Yes they are.
breatheasy – a couple of points to note as per the below.
1) Not sure how you define ‘enough SNG001’ produced for the purposes of MAP, however I would urge caution making such a statement. There was limited supply for ACTIV-2 phase II, hence a restricted number of trial sites, although it was not clear whether it related to SNG001 or placebo, which if it did relate to SNG001 would suggest there was not sufficient available stock.
2) You don’t seem to have factored in costs related to SG018 – that’s my interpretation so apologies if I’m wrong here. I would estimate that to be between £20m and £25m with most of this cost to land in Q2 2021. Not all research and development expenditure relate to manufacturing batch testing and upscale activities.
The placing from 2020 allocated about £33m to manufacturing activities which includes batch testing etc. Whether this £33m includes blow-fill-seal I’m not sure as BFS wasn’t mentioned in the placing RNS.
3) Synairgen most definitely have not produced 100k doses per month from Jan 2021. Actually the company’s aim is for 100k treatments and not doses per month. Going back to the AGM of 18 Jun 2021 the following was said by RM:
- They have manufactured multiple drug substance batches i.e. interferon beta; and
- several drug product batches which are now undergoing stability studies.
- This is done to validate commercial scale end to end manufacturing process.
All this takes time as the results from the test batches need to be successful and signed off prior to starting production. My rough estimate is that we have a few ten’s of thousands of treatments in stock as a result of batch testing excl BFS test batches. Whether actual production has started is unknown.
On manufacturing I would suggest reading the thread ‘Manufacturing - comment from AGM’ where we discussed this back in Sep. It gives you insight into how big the test batches have to be to pass regulatory requirements. Link provided below.
https://www.lse.co.uk/ShareChat.asp?ShareTicker=SNG&share=Synairgen&page=12&thread=DB0150C0-78E5-4E5D-92EB-B8AB64EF23BF
This seems like an interesting article, however you do need to be a subscriber to Future Science to access it. Maybe someone with access could potentially share some key findings. Google seem to have identified SNG001 being mentioned.
Nebulizer systems: a new frontier for therapeutics and targeted delivery
https://www.future-science.com/doi/10.4155/tde-2021-0070
Abstract:
Drug delivery via the pulmonary route is a cornerstone in the pharmaceutical sector as an alternative to oral and parenteral administration. Nebulizer inhalation treatment offers multiple drug administration, easily employed with tidal breathing, suitable for children and elderly, can be adapted for severe patients and visible spray ensures patient satisfaction. This review discusses the operational and mechanical characteristics of nebulizer delivery devices in terms of aerosol production processes, their usage, benefits and drawbacks that are currently shaping the contemporary landscape of inhaled drug delivery. With the advent of particle engineering, novel inhaled nanosystems can be successfully developed to increase lung deposition and decrease pulmonary clearance. The above-mentioned advances might pave the path for treating a life-threatening disorder like severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which is also discussed in the current state of the art.
Hats off to Hull University Teaching Hospitals NHS Trust for recruiting 28 patients to SG018. That’s pretty impressive stuff!
https://mobile.twitter.com/kbrespresearch/status/1458709732299100161
Pretty clever little trick to have Prof Monica Kraft, MD comment on the trial's completion for this RNS giving it some further local US weight. She received the Presidential Early Career Award for Scientists and Engineers, awarded by President Bill Clinton at the White House in 2000.
https://medicine.arizona.edu/person/monica-kraft-md
Bigjohnny - the protocol states that unblinding for primary analysis will occur once ALL patients have completed the Day 35 visit.
To eliminate any uncertainty as to when exactly data will be unblinded and analysis thereof can commence I’ve summarised below what the protocol states. This is mainly in response to yesterday’s comment by RM about potentially delivering data during the second half of this year and some comments made on the board.
Summary: As per SG018’s protocol the primary analysis will be performed once all patients have completed their Day 35 visit. From this point onwards the study will be unblinded. A follow up analysis will be performed once all patients have completed their Day 90 visit.
It’s therefore not possible to unblind primary endpoint specific data post Day 28 and then progression to severe disease and/or death data post Day 35.
Question to some of the experts. Any idea why progression to severe disease and/or death would be measured over 35 days and not 28?
RM did not say data during 2nd half of this year. He said the ‘POTENTIAL’ to deliver data during 2nd half of this year.
Financial and calendar year are the same.
Less risk
Polygon won't be acting on behalf of another party. Well, can't say for sure, but I'd be very surprised if they do. It's contrary to their stated strategy which is event driven. They tend to build up a significant enough stake to influence the price in case of a take over i.e. prevent a take over at an undervalued price.
mAbs were excluded from the study focusing on high risk patients while included in the low risk group.
Thx for that SilverBackMerc. Very interesting indeed.
Is it maybe a case that we activated sites again to ensure a further delay does not occur? Guess we won’t know. Anyway, I’ll take that as positive news.
*in a week
35 days for observation as it includes deaths and progression to severe disease. Then add 3 - 4 weeks until we hear anything - could even be sooner. But, best to set expectations back.
SilverBackMerch - that’s interesting. However, I think that’s not the case as they want to keep the official message of ‘still recruiting’. If we were still recruiting in the UK for example then why is the trial not yet filled? I’m of the opinion many sites in various countries have stopped recruitment when the country’s allotment was reached. With the number of sites we now have they could’ve filled the last remaining 20% in a week - I’m being prudent by saying ‘I’m a week’.
The AIDS Clinical Trials Group (ACTG), the largest global HIV research network, which recently expanded its focus to include evaluating outpatient treatment for COVID-19, today announced the launch of A5404, a clinical trial studying how prior infection with SARS-CoV-2 and receiving either an investigational COVID-19 therapy or placebo/active comparator affects participants’ immune responses to mRNA COVID-19 vaccines.
https://actgnetwork.org/2021/11/03/actg-launches-study-evaluating-how-a-history-of-covid-19-and-prior-investigational-covid-19-treatment-may-affect-covid-19-vaccine-response/