London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Any body know when we may get some?
Eileen might know or the bois at the reddit group
it highly unlikely we will receive an interim analysis
The consensus view on reddit is that they wont stop for an interim - with the number of global cases currently and the number of sites now setup, the feeling is that we're only a couple of months away from last patient dosed. So why add any ambiguity to results released at an interim point - or incur any delay in getting the final results analysed and published.
What about confirmation we are in phase 3 for Activ2?
To those involved, it seems a foregone conclusion and no news is good news - but should we expect an official announcement?
It’s definitely NOT highly unlikely to get an interim readout. Very possible indeed, does not mean it’ll happen, but quite possible. Remember the trials are delayed by quite a bit, there’s potentially going to be a great clinical need this winter and so if the SG018 interim data, which they will have and may already do, looks promising the Authorities would want to proceed instead of waiting for a Dec readout. It’s about that ‘ripping point’. The trial will/can still be completed without interruption. Why would you go into the winter season knowing SNG001 is efficacious based on strong supporting data, but decide against it for the sake of a full readout while you already have strong interim data. That’s why the idea of rolling reviews were brought in to expedite approvals.
A similar scenario might play itself out re ACTIV-2.
Worth listening to this again from 8.10 - 09.10
https://youtu.be/nhFqeW6sIXg
Don’t get me wrong I don’t bank on an interim, however I’m just of the opinion is very likely.
*Tipping point
May i ask if there is a safety monitoring committee. If so why would anyone do an interim - what would you do with the result.
They might try and get topline data out as soon as last patient hits primary endpoint - timing of that is key.
if other results come out they may try and get a blinded committee to examine data for futility. Seems to me there are a number of projects on-going. Drs talk to each other. Standby :-}
My understanding is that SNG100 in the activ-2 trial, is that the phase 2 and phase 3 are rolled into one and if at any point it fails it's endpoints then it will be dropped. As we have not had any news it must be still progressing, which is good news. The end date for this trial is estimated to be May 2023. This does not mean SNG100 will take that long, though they are studying what effects SNG100 has on long covid. I could be wrong but thats how i read it on the activ-2-trial info GLA
Wouldn't the most valuable piece of interim news be that the drug has been in vitro tested against the Delta variant and that it produced similar positive result as was achieved with the other variants recently tested against ?. This should have been done weeks ago seeing that it's test tube analysis I would have thought ,unless results require some sort of peer review before release ?.
No news isn't good news in this case as Synairgen didn't hesitate to show the world how the drug smashed the other variants ..Smashing the Delta variant would be a massive PR win .It makes no logical sense to withhold this Data IMHO.
mact - Yes the expectation is that there will be an RNS from SNG on official progression to Phase 3 - since its market sensitive information that would materially affect the SP.
Tattyhead, I think it would be nice to see results against the Delta variant, but not essential IMO as the vast majority of patients trialling SNG001 at this point will be infected with the Delta variant, if the stats are anything to go by. However, we do not know the timeframes involved in that lab variant testing process and it should not be assumed that it is a fast and simple process. I have no doubt that it will be rigorous and quite possibly take more time that you would think. We don't know how long the last process took, just what the result was. Bear in mind that these tests are done a specialist lab in Europe (Holland if I remember correctly?) and I would guess that lab is in extremley high demand given worldwide pandemic pressures. Patience is key.
The RNS dated 24th May, states that the phase 3 trial in India using SGN100 is imminent. Which was 2 months ago, so should be well advanced now. A lot of people think that SNG should be releasing news every time they fart. They are quietly getting on with things in the background and if anyone needs any info should e-mail the company. No news is good news.
Fruitsnveg - yes I'd like a delta variant in vitro test too, purely for a bit of free marketing and to keep hammering the point to the media that SNG will work on any current or future variant (unlike mabs). I've heard others make the valid point that SNG were likely asked by the EMA to run the previous variant in vitro tests (in the EMA lab in the Netherlands) and that SNG wouldn't conduct another variant test unless they were specifically asked to do it - since it doesn't really add anything from a scientific perspective .
Doc - An unblinded analysis is planned of which the results will be reviewed by the IDMC (independent data monitoring committee) once a certain number of patients had been recruited to confirm ‘proceed with’ or ‘stop’ the trial. You won’t conduct an expensive phase III trial without this checkpoint. With two months of recruitment left I’m sure we’ve reached that point. Well, hopefully.
This does NOT mean they will do additional analysis if required or being asked to by the Health Agencies for possible early approval, but it’s certainly not inconceivable given the circumstances we’re finding ourselves in. That’s my view which is in line with comments made by RM himself earlier this year of which I've posted the Youtube link.
There’re strong public health and commercial reasons influencing the ‘tipping point’ decision.
Again, I’m not saying it’ll happen as I certainly don’t want to set myself up for disappointment if it does not happen. Just saying it’s possible.
The virus is unfortunately out racing science. Meaning it's highly likely that Synairgens treatments work against all variants, It's just the virus is mutating quicker than than lab tests can be achieved.
Sng001 works against the Kent and South African variant in lab conditions. Good enough for me, because the difference variants will keep coming. In a years time, we could be facing another variant. It's fruitless keep doing lab tests as it's highly likely the treatments work.
Good weekend all.
I believe the confusion regarding Synairgens treatments is that the vaccines come with more questions than answers and the integrity of Sng001 should not be compared
Based on my understanding and reading of the Trials, the estimated completion date is the 1st of Oct 2021, which according definition on NIAID, is the the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
The Study states patients will be monitored for up to 90 days, which with simple math suggests that the last patient should have been dosed as part of the Phase 3 NIAID trial. (obviously estimate dates)
https://clinicaltrials.gov/ct2/show/NCT04732949?recrs=a&cond=covid-19&age=12&phase=123&draw=8&rank=140
bdcarr123 - 01 Oct is also stated to be the primary completion date. So either it’s an error or a misunderstanding of the meaning of the dates. Either way doesn’t really matter anymore. The latest as per the U.K. version of the abridged protocol is a recruitment end date of 01 Oct.
Matterhorn. I trust you received my message of apology.last week.
Warm regards.
I did see it. Thx.