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In a National Emergency I though the Gov had given billions to help with development of vaccines and to private companies for mega laboratory testing and new technologies .
and guess what! It's not funding and cash that we needed but a bit of publicity and advertising of the home trial which would be peanuts compared to the billions invested eleswhere!
"they are not obliged to assist."
No they are clearly not unless it suits themselves.
They can assist other companies trying to come up with solutions for this mess but when it comes to us then there is clearly nothing.
Eva - they reported that they have 10 mil still in the bank. Why was this not used to advertise the trial?
The UK Gov have been on Sky news pleading with people to take part in clinical trials relating to COVID.
Why not the SNG trials?
Just imagine if you were RM...would you want this Government to be part of your Baby...
Exactly, hundreds of thousands of cases and we can't fill the trial. Answers need to be given about this!
Yes and let us not forget when the trial began for patients in the home setting - on the
26th of May 2020!
5 months ago!
Look at the amount of COVID19 cases since then. And they can't find 120 willing to participate?
Come on now ffs, WTF is going on...Zero support from the government and a clear lacking from SNG here after all the effort to advertise it..Why? They have stated millions in the bank ffs!
Lets start to get the message out to the population please Richard, you have the cash to do it and you don't need to waste every second on the phone to the big pharma anymore.. It's only our time if you make it happen!
I agree oil
Just think if they had a successful Home Trial and people being treated at home you would not have to listen to Andy Burnham and GoV squabbling over the NHS being overwhelmed .It is a disgrace greatest opportunity of all missed that is Home trial imv
I see what your are saying but we are not in an ideal situation. Peer review of phase 2 trials are clearly not required before moving onto a Phase 3 trial in the current environment.
What it looks like they are doing is moving onto a phase 3 with each Arm of the study. I think we will have a P3 home study once the home results are in but for now we are moving forward with the hospital arm as that's where the data is proven at present. All imo of course.
Ideally you would need a positive @ home study result, and a positive peer review before start of hospital Phase 3 trial.
If they are not positive that might hinder phase 3 progression. That's the point I am making.
If they announce that the last patient has been dosed tommorow in the home trial then we can expect the results in around 2 months going by what happened in the hospital trial. However the final dosing is not looking imminent. It is a disgrace if you ask me as the amount of COVID patients have been massive since the home trials begun and they have not been able to get the 120 patients enrolled. This is purly because of the lack of advertising about the trial and that is not good, neither on the part of the UK gov or SNG and neither is it good for each and every person in the UK/world weather a share holder or not. It's a pure disgrace!
Bh2s...
You seem a bit unsure about your investment.
There are plenty of other stocks for you to chose from.
Don't overcomplicate things.
Filtered.
Good night
Phase 3 is a hospital only trial for people at score 4 on WHO ordinal scale.
This will not include home trial patients.
No i disagree. The Phase 3 is for folk in hospital who are on oxygen. This is following on from our phase 2 hospital trial and is most likley to be not associated with the home trial.
True Oil, - you have reminded me they usually RNS this event.
But if Ph3 can start 30 days after IND application accepted, we surely must here something by then.
why are the results of the home trial immenent?
They have not dosed the last patient yet?
That’s a great shout and a very plausible outcome I’d say...
Last line:
The results of the 'At Home' study are imminent.
With the COPD / Hospital Covid trial / @ home study results available, will a positive peer review, and phase III trial proceeding successfully, stop the Ph3 trial for 'benefit'?
The stock is worth £9.90
Big hug guys x
From Placing and Open Offer RNS 14.10.2020 -
"Following a positive pre-Investigational New Drug (IND) Application meeting with the U.S. Food and Drug Administration (FDA) regarding the design of a Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients, and with manufacturing scale-up activity underway, the Company is pleased to announce the proposed Fundraising of up to £87.0 million to support the Phase III clinical development of SNG001 for COVID-19 patients."
Note the use of Placebo.
+++
source:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024796/#:~:text=Ethically%2C%20clinical%20trials%20must%20sometimes,%2C%20benefit%2C%20and%20futility%20concerns.
Ethically, clinical trials must sometimes be stopped early when the results show no justification for exposing human subjects to additional potential risk by continuing the trial. The 3 ethics scenarios are based on safety, benefit, and futility concerns.
1.
Safety: The risks to human subjects unexpectedly outweigh the benefits because of unexpected severe adverse events. When the institutional review board (IRB) approves a trial, it has determined that it meets US Food and Drug Administration (FDA) criteria for IRB approval at 21 CFR 56.111. Section (a)(2) states: “Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”11 This determination changes when a study unexpectedly causes serious illness or death in human subjects. The study may then be suspended by the FDA, the sponsor, and/or the IRB until the risk-benefit ratio is reevaluated. An example is drug manufacturer Bial's phase 1 clinical trial in healthy volunteers.12
2.
Benefit: The study hypothesis is unexpectedly proven early within predesignated criteria. Continuing to expose subjects in the inferior arm to additional potential risks or keeping them from benefitting from the therapies in the superior arm is hard to justify ethically. An example is the SPRINT study discussed above.
3.
Futility: The study hypothesis is unexpectedly shown to be unprovable within the constraints of the trial based on a statistical analysis of early study data, usually done at a planned interim analysis. In such cases, there is no benefit to balance against subjecting subjects to potential risks. An example is the cessation of the Verastem VX-6063 phase 2 clinical trial.
+++
Might the SNG001 phase 3 trial be stopped for Benefit reasons? - Recall that 3 patients died recently taking placebo in ph2 trials.
RM would have to be careful developing the predefined stopping rules criteria.
He has spoken to the FDA, and this might have been a discussed. We already know SNG001 is safe.
The results of the 'At Home' study are imminent.
With the COPD / Hospital Covid trial / @ home study results available, will a positive peer review, and phase 3 trial proceeding successfully, stop the t