George Frangeskides, Exec-Chair at Alba Mineral Resources, discusses grades at the Clogau Gold Mine. Watch the full video here.
Yes. (Out of the 16 secondary outcome measures those three are the key ones.)
The definition I work off, which is in the link you provided (further down the page) is that topline results cover primary endpoints, (only) key secondary endpoints, safety data plus some demographics. Subsequent announcements will include all endpoints.
If you refer to the trial protocol as per the ISRCTN registry you'll see they list the key secondary endpoints - scroll down until about halfway down the page .
https://www.isrctn.com/ISRCTN85436698
Bogo – thanks for your explanation.
Ndn71 – are you referring to the broader set of outcome measures i.e. more specifically the secondary measures or the top line measures? The analysis for all outcome measures could take quite a while, agree. With regards to top line results it should be fairly ‘quick’ in comparison.
I understand the point you’re making and would say the chances of it being repeated for SG018 are far slimmer than in SG016 hospital and home. The primary reason being that in SG016 the focus was on high risk patients whether they were in hospital or in the home setting whereas SG018 is focussing on a cohort within the high risk patient population, only those requiring oxygen in the hospital setting, which was vindicated by the analysis you’re referring to when the two SG016 datasets were combined.
The combined analysis specifically referred to those who are ‘marked or severely breathless’ which would translate into ‘require oxygen’ in the hospital setting and ‘marked or severely breathless’ in the home setting. As such it’s unlikely, although not impossible, that a further cohort within the ‘require oxygen’ group would emerge allowing for a much quicker timeframe when it comes to analysing the data for the purposes of top line results. The data from ACTIV-2 phase II are not known to us, but it seems from version 7 of the protocol that the data also supported this approach.
For the sake of memory the top line data would cover:
1) Time to discovery
2) Time to recovery
3) Progression to severe disease or death
4) Progression to intubation or death
5) Death within the first 35 days of first dose
GETINTHERE - you have misinterpreted Ndn71's post. It was his/hers reasons as to why Synairgen are still under the radar. It had nothing to do with negativity.
BigjohnnyWin - let's not share details about the amounts invested. It's personal information and has nothing to do with any of us.
If any of you have experience in clinical trial data management, or knowledge thereof, it would be great if you could comment. I’d like to better understand how the quality control of data is handled in practice ensuring discrepancies are dealt with and closed out in ‘real time’. Executing quality control throughout the trial will not only save time, but also ensure high quality data.
In order to commence with the data analysis the database needs to be locked which in turn can only be done after a quality check and assurance i.e. attending to any and close out all data discrepancies.
Looking at what SG018's protocol states it would seem that any discrepancies could and probably would’ve been addressed during the trial with hopefully only a few residual issues post trial. I know it’s difficult to say, but would it be reasonable to expect for SG018’s database to have been locked let’s say within two days post day 35? It shouldn’t for example take a week – hopefully not.
Below are extracts from the SG018 protocol
9.1 Quality Control (Monitoring)
In order to verify that the study is conducted in accordance with the study protocol, ICH GCP, local regulatory requirements and other applicable guidelines, data will be monitored at regular intervals. This will allow the sponsor to ensure that the data is authentic, accurate and complete. Source data will be verified either on site or remotely.
9.2 Quality Assurance
In compliance with ICH GCP and regulatory requirements, the Sponsor, a third party on behalf of the Sponsor, regulatory agencies, IRBs or IECs may conduct quality assurance audits at any time during or following a study.
10.1 Study Source Documents and Electronic Case Report Form
The Principal Investigator is responsible for ensuring the accuracy of the data entered. The study source documents should be completed during the study visit and once completed, site staff should enter the data into the eCRF.
If you refer to the link I provided and scroll two paragraphs up from the charts it uses the term 'phase III candidate'. The question is what exactly does 'phase III candidate' mean according to the authors. Is it a drug going into or undergoing a phase III trial or one that provided successful results in a phase III trial. That will determine how to interpret the 81%.
London's reported cases are up 157% week on week whereas for England excl London it's 28%. To give some further perspective last Saturday London was up 29% week on week vs England excl London's 8%.
HelloSanDiego - refer to slide 29 for the %s quoted by Raphaking.
https://www.bioindustry.org/uploads/assets/2552f01e-5b03-47ca-9794ba0d428a6cf5/Opportunity-on-your-doorstep-A-guide-to-investing-in-the-UK-biotech-sector.pdf
If there’s anything to deduce from the timing of the changes then it may mean things are starting to fall in place so to get ready for launch.
Other than that I agree Fruits. Good location, business friendly and low taxes.
A few bits and bobs, including the latest on Synairgen Research (Ireland) Limited.
One share issued at EUR 1 which is still held by BDO Ireland.
Richard was made a director on 29 Nov 2021.
The registered address was changed on 17 Dec 2021. Based on a search of the post code it seems the registered address is that of Reddy Charlton Solicitors. So it seems they’re the company’s Irish lawyers, although there is no way I can confirm this as factual.
Information obtained from reports bought from https://core.cro.ie/
Fruits - Not sure if you meant Sir Bell made that comment, but it was actually Prof Whitty.
The other comment made by Prof Whitty which was about spending a lot on Pfizer, but receive no real benefit, aligns very well with what’s been discussed on the board a few times. And then, I don’t want to suggest he referred to SNG001, but which other antiviral could he be referring to. Can’t be Merck’s pill.
Prof Whitty’s comments:
'If we can see a couple of other good antivirals coming over the hill, and we might well in the next month or two, then combining those drugs is clearly the way forward,' he said.
'And that could prove to be pretty interesting. But you could blow a lot of money on the Pfizer pills and actually not make much impact on severe disease.'
Interview with Dr Eric Folken - principal investigator ACTIV-2 trial, Bradenton Research Centre. Not much at all to gain from this interview, however it seems as if phase III is underway. How does this compare with the latest insight from Reddit? I remember Matml74 saying the expectation is for the trial to (re)commence just before Christmas. https://youtu.be/G803aMK1xy0
Ndn71 - breathlessness is 'fuzzy' according to you. Could you please share your credentials with us so that we can compare you to Prof Sir Stephen Holgate's? Breathlessness works for him.
Published today by SAB.
'Although SAB-185 retained potent neutralization of the Omicron variant, it did show a mild-moderate reduction in potency compared to the wild type. Additional analyses are ongoing, and the full data set is being prepared for bioRxiv, the online life sciences archive for COVID-19 SARS-CoV-2 preprints.'
https://www.biospace.com/article/releases/sab-biotherapeutics-announces-sab-185-retains-neutralization-against-omicron-sars-cov-2-variant-in-vitro/
2/2 – covers the size and number of manufacturing test batches
Batch size:
Both the EMA and FDA have a 10% rule meaning the validation batch size should be at least a minimum of 10% of the commercial production batch size or 100k. (The 100k would refer to doses.) Based on RM’s comments of 100k treatments per month that would equate to 10k treatments or 140k doses.
Number of batches:
In my earlier post I mentioned three batches, but that’s based on old (FDA) language. The FDA does not specify the minimum number of batches while the EMA seems to require data on a minimum of three batches. The number of validation batches will be dictated by the required confidence level while achieving statistical significance.
Based on the above I would say it is probably save too assume that we have at least 30k treatments in prefilled glass syringes. On top of that we have blow fill seal (BFS). Whether BFS would be 30k treatments too I don’t know, but it could be.
Page 17 section V(A)(1) https://www.fda.gov/media/70949/download
Pages 5/6 section 5.1 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf
(1/2) There is no need for a manufacturing update since it was covered with the release of the interim results. (See below.) Remember the only production taking place or that took place was in regard to running test batches. I only see a need for an update should the blow fill seal run have failed for some reason.
Running test batches is a regulatory requirement. The size and number of the test batches are a function of commercial scale ambitions. Refer to my next post (2/2) which is an amended extract from an old post when we discussed test batches.
If your question was an indirect reference to pre-orders then I would say the answer is no, not until at least confirmation of successful phase III results. Synairgen don’t strike me as company that would release such news unless there is a high level of certainty.
Slide 25 https://www.synairgen.com/umbraco/Surface/Download/GetFile?cid=cc00c540-818a-4f3d-a5b0-40b9efe83639
1) This will provide tens of thousands of treatment courses should an EUA be granted
2) Multiple commercial scale drug substance batches have been completed by Akron
3) Multiple commercial scale batches of prefilled glass syringes have been filled by Catalent
4) Commercial scale blow fill seal run with Woodstock Sterile Solutions is underway (formerly a Catalent site)
5) Potential to increase capacity to ~100,000 treatment courses per month. Government support required to accomplish this larger scale of manufacturing operation
*and not 101
Doc83 - if a or the last patient pulls out during the treatment period it would be recorded as such and investigated with reasons for withdrawal forming part of overall dataset. He/she would not be replaced by another patient.
That’s partly why SG016 hospital ended up with only 86 patients, and 101, included in the ‘per protocol’ analysis.
Ndn71 - there will be no RNS announcing unblinding or receipt of unblinded data. It has never happened before.
I’ll just point out that Aerogen just signed a commercial deal with CanSino, Chinese company, who’s developing an inhaled covid-19 vaccine.
Thx for that Matml74
Just as a general note - many on here seem overly excited and ‘rightly’ so, but I’d caution against inferring anything from this interview other than what SSH said. Remember he speaks with great authority being in this field for decades, co-founded a company to further his work and so of course he’s confident.