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Doc Dan - again, sorry but need to correct you, on Universal they have had access to 350 patients data and the P2s have been designed taking those assessments into account, along with the 2000 patient data from the wider So’ton hospital inpatient database over the last 18 months for hi viral load that is being analysed
DocDan - your views on how these P2 trials will run is not accurate. This is where attendance at the meeting and the ability to discuss with the team after elicits further detail. These trials will also include open label approach, where the intervention is not run on an randomised basis, against placebo product but on open label, where the trial data can be studied on the go - and because of the targets, such patients are already known to clinicians as they are regulars each virus season - ie they are repeat visitors. So the chances of the wrong patients, wrong therapy in those tight target populations are virtually eliminated - that’s been the purpose of learning from Sprinter plus study from Universal and the wider So’ton hospital virus inpatients data. It is only when the much wider ‘elderly’ subset is targeted that you need the bigger trial approach. This was all confirmed by questioning RM and PM in the post AGM - which shows the value of ‘hanging around’!
Doc - RM was challenged about his forecast last AGM that SNG would be in use - he said at the time a year ago he believed that a platform trial was likely….within just a couple of months they were falling away in terms of funding or central commitment and so the position changed
Mani
You keep bleating on about finances - it is usual for the annual accounts and auditors report to only make reference for the next 12 months because guess what….the auditors repeat the process again for the following period.
If you bother to examine the accounts for the last few years, and strip out the exceptional spend such as that associated with Sprinter, the normal running costs with the current head count does not make SNG an expensive company to run. My estimate is that have in fact enough cash still to run for another two years at least. What doesn’t change is that the annual report will timebox what is allowed to report.
What does need to change is to be able to finance further activity to obtain the necessary data from trials - hence the behind the scenes activity to secure the optimum route.
The company now has a meaningful amount of trials data from a range of trials over recent years. Whilst the endpoints of Sprinter failed, the post hoc data finds provided insight and intelligence on target patients and it is outputs like that which start to drive the commercialisation route. Regulators don’t simply authorise clinical results, they also want evidence that there is a sustainable market for the therapy. That is why often P3 candidate therapy trials require more than a single run to achieve the necessary and required results.
There is every likelihood that history will show that Sprinter was a pivotal point on SNG’s route to authorisation and commercialisation - simply dismissing it as ‘a failure’ pays scant regard to the learning from it.
Strive - 100% - I think you’re wrong….think Company’s attitude to platform trials will have changed - 2 years to get the Activ2 data from start….no control over trial protocol etc. The only way to generate the data that they need is to generate a funding solution and collaborate with interested party(ies) on the commercial outcome following authorisation.
I think you will find that the UAE are a rising force in biotech investment
https://www.consultancy-me.com/news/5141/abbas-berdi-pwc-on-uaes-ambitions-to-build-a-biocluster-hub
Just want to pick up on a couple of areas Doc. I don’t necessarily agree with the point you make about having to go back to P2 on each individual virus, and also you highlighting COPD for a P2.
The earlier COPD trial was a P2 and was set up to capture a range of respiratory viruses - although halted early because of Covid it was analysed and reported last year, identifying influenza and HRV as being the most common viruses presented. There was some statistical significance identified and also acceptable safety profile so perfectly acceptable P2 outcomes. Of course there was the even earlier trial on Asthma patients with, again, a range of viruses captured but in low numbers.
The SA panel with Rick Bright touched on the need for greater flexibility in trial approach for testing a broad ranging therapy and it would seem reasonable that data sets can be combined for consideration - such flexibility has been allowed before, such as the AZ vaccine trial which turned normal protocol on its head!
TLW
The difference today is that the normal course of events is to release the detail in the early morning RNS and then host the briefing later….unless the RNS comes out shortly that is a significant departure from normal protocol
As expected Doc - you miss my point completely - read the P2 paper, they were aware of the presence of both ‘new’ therapies coming into the hospital population…..you suggest that they ‘missed it… they didn’t, it’s referenced as I say. What they didn’t know was the impact both would have in combo with SNG… only a trial would highlight that which it did
Did they Doc? Did the company miss the presence of Dex and Remdes…..how daft of them! Maybe they didn’t - maybe they suggested that other therapies were also needed subject to further trials….suggest you reread the Lancet paper on P2 - like the discussion piece towards the end. Just ti make it easier for you have attached the link
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7836724/
Just looked at your history - one track record - you jump from board to board shouting ‘short’ ‘only heading one way…..blah blah blah’
https://moderndiscontent.substack.com/p/the-possible-side-effect-of-mercks
There’s also something about Friday news usually being ‘less good’…..AZ also released a full RNS this morning informing that a P3 trial for a Motor Neuron Disease had been curtailed - perhaps the Covid news release was timed to attempt some balance - certainly the SP for AZ has been rather muted this morning
DP - think you will find that it’s income tax that becomes payable on exercise - this would have been under a non-tax advantage scheme…. Where selling some of the shares is the accepted method of dealing with the cash flow issue. This BDO link explains :
https://www.bdo.co.uk/en-gb/insights/tax/global-employer-services/non-tax-advantaged-share-option-plans