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VanV - Agreed just look at the technologies across the board that are making waves, many are still in their infancy of development but I think there is a growing consensus that we need more than is in our current arsenal as it where.
Nolupus - I fail to see why it's such a big issue that Synairgen are running the lab that confirms an active coronavirus infection themselves.
If they get a false positive that patient could easily go on to be given placebo, false negative and they don't make it onto the trial.
I can clearly see why they have set up their own lab to test the swabs since the whole point of the trial is speed, if they control the whole courier/lab process they will enroll their patients in the quickest way possible.
Once they are on the trial its a whole different ball game and I expect all the usual best practices to be in place.
Thanks nolupus,
But I'm not understanding your similitude, so please be blatant as I'd rather not read between lines.
Johnht,
When the home team are playing on their own ground and the referee is the Lord Mayor and the linesmen are all town concillors well anyone might just wonder if it's Going to be a fair match :-)
thanks for clarifying between the announcement of the intention to expand the trial to community and the formal commencement of the trial in the community setting. Positive steps.
aj242 - The only point I disagreed on was that there was only old news in the announcements. I agree with you that this will likely drift for a while now until we get closer to the results date.
Hmmm, totally understand where you are coming from. I just don't think we should be expecting this to go back to its recent highs until after/very near the interim analysis in July. Recruitment for this community based cohort will take a while too. As I have mentioned before, I have been watching this share for a while and for me its all about my entry point. Don't intend to de-ramp this share as I totally believe in the drug in question so apologies if it has come across that way, I will be investing, for me the question is timing for when I should pull the trigger and buy.
GL to all, regardless at what price you have bought, come July, you will all be in profit.
Thanks nolupus, which bias are you referring to specifically?
Ghia,
I have already noted that these are exceptional times and that speed is very necessary but I think it's a error to have Synairgen directly involved in the process in any form .
Ok , this is a P2 trial so we should'nt be too worried about the ´ethics ´ but as Richard would say ´ data is king ´ so the Possible P3 will have to be designed differently , imo
Nolupus - Just another example of how Synairgen and Southampton University are breaking new ground, the medical industry for the first time in a long time are open to change. Mindsets have changed because they are forced to adapt and move out of their comfort zone. This is a great time for medicine.
"This is the first trial of its type to be conducted "remotely" in this way and if successful, may point towards a potential domiciliary care protocol for this and future viral outbreaks."
Yet again we could be creating the trial blueprint.
Also Synairgens involvement seems to be to verify that the Swab taken to confirm the Covid Infection is positive. Seems perfectly fair that Synairgen control this aspect of the trial, probably necessary due to the bottle necks in the countries Lab Infrastructure.
Should read CRO .. fat fingers
Johnht,
It's extremely unusual that the sponsor of the trial is directly involved in the clinical trial, for many ethical reasons
CRI are there to ensure that the trials are managed in a ´ transparent ´ and unbiased way but these are exceptional times .
Not with you nolupus are you suggesting they are over done?
Ghia,
They have been fast out of the blocks all right , and they may get a speeding ticket for that !
Thanks @Seb enjoy the pimms
The CEO of Synairgen, commented: “We are really pleased to be able to expand the SG016 trial to patients in the home environment which enables us to test the drug much earlier in the course of the illness."
It says "really pleased".
Share price is falling due to a distressed institutional investor still selling.
aj242 - The old news was that we where preparing for at home trials, the new news is that as of today you can be enrolled on that trial.
They have overcome all the technical and logistical issues to make it happen. That in itself is a piece of new news which as you can see has been picked up by 3 tabloids already today.
Hospital cases are falling our trial is now moving to where the problem exists that has to be a positive, and once again we are the first to do it.
We where one of the earliest Covid focused treatment trials and now we are the earliest to roll out to at home.
Regardless of trial outcomes you have to hand it to Synairgen they have been fast out of the blocks.
The CEO of Synairgen, commented: “We are really pleased to be able to expand the SG016 trial to patients in the home environment which enables us to test the drug much earlier in the course of the illness."
It says "really pleased".
Share price is falling due to a distressed institutional investor still selling.
Nolupus - Surely once COPD data is unblinded and published continuing the trial is a bit pointless. So for now it's paused pending interim analysis wouldn't be surprised if once that analysis has happened the trial gets stopped anyway.
VanV I agree with your comments that the July top-line being over done, however the wording is very positive from the experts and the company.
Take note,( Russell Group) University of Southampton is going to be worldwide famous, for their breakthroughs in 2020.
Professor Tom Wilkinson, Professor of Respiratory Medicine at the University of
Southampton and Trial Chief Investigator, commented: “Expansion of the SG016
placebo controlled trial where we will be treating patients at the first sign of COVID-19
symptoms is something of a first and reflects the ingenuity and expertise of Synairgen
and our researchers here at the University of Southampton. This novel approach is
designed to reduce infection risks for both patients and front-line workers. Critically, it
also allows us to gather clinical evidence for SNG001 more quickly, a treatment we
believe could play a crucial role in tackling the COVID-19 pandemic.”
Aj242 appreciate your view, however let's not under sell either. I'm stating as per the company rns and have enough understanding of the subject to know it is very positive.
Ghia,
You're an intelligent lady so read between the lines :-)
But the trial is not finished ...
Statistics my friend.
Hmmmm disagree. This isn’t new news. They’re happy with progress Yes, but the expansion is not new. The only new thing from that is that the trial read out is now in July rather than June which makes sense as covid patient admitted to hospital are now few and far between.
Solid company, but don’t ramp this over an RNS that doesn’t say much.
For many who think this is old news think again, we now know that this is positive news as described by the company itself. Here are the key points (any questions) -
Synairgen are "pleased" with the p2 clinical trial that is "progressing well".
Further details on this good news will be available as top line data in July 2020.
Of the 100 people, 98 dosed in the hospital setting.
For the home clinical study, this novel approach is "designed to reduce infection risks for both patients and front-line workers".
This now underlines the positive effect of sng001 for covid-19 positive patients and front-line workers albeit the official data now available in July 2020.