The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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I'm loading up, whilst the penny drops.
GLA
Why? this was first submitted 11th January but not displayed until today...never usually that long of a wait when reviewing sites and updates.....
Twice now with synairgen details about trials have gone on clinical sites and then rns 7am next day.....
Thanks for sharing ggg21...!!
GLA!
My understanding is that they are checking the validity of the questions used as part of the trial. It sounds like its ust an observational study so I don't even think these 25 patients are necessarily even going to actually get the synairgen treatment or even placebo. Just need to be someone who was positive and hospitalised due to covid. But it is interesting that US are looking into this.
Thanks Matml74. It was first published to the website on 11th January, but only appeared around lunchtime today for visibility, so go with your post below
That makes sense Matml74.
Why else ask these questions to 25 people that weren't on the trial. Well done figuring that out.
Brilliant. thanks to @gggg21
Looks like it is the post-marketing requirement for new drug application!!!!!
It is part of the QA/QC. It’s likely in the SAP and was always going to happen.
The questions aren’t asking for new data it is check that the questions asked through the trial to assess patients OSCI once they were discharged from hospital were easy to understand.
What this small study (25 people) is doing is asking the patients about “ their relevance, ease of understanding and clarity needs to be shown, which is why this interview study is being conducted.
Basically finding out if patients found the questions easy to understand and their relavence to symptoms.
This is just tidying up clinical trial database prior to readout.
Thanks Ghia, at the gym at moment so was difficult posting and reading all the documents
Gggg21 - exclusion criteria for the trial is that you must not have previously signed the sg018 consent form so the 25 patients are a separate set.
Probably to look at the accuracy of those questions
If this was ongoing in November.....then would have been discussed in october....Polygon increased their holdings by a lot and very quick in october and early Nov...going from 11% to over 15% in space of a few weeks.....maybe just coincidence
Yeh my bad on the long covid, but to add something onto the trial at the last moment...obviously this info you would think was requested given they did not have the data.....wasn't there slightly more recruits than the adjusted number in total? Started 17th so you could say 7 days after last recruits when they left hospital...for me this is 1) A request by an authority for data specifically on this and 2) Getting all paper work up to date and published.
I don’t see how this relates to long covid at all. Its just an assessments of then methodology used in the trial for both primary and secondary endpoints.
"this was started on 17th Nov....so they did not have the data then....iffy like heck!'
Spot on! I was just going to say the same.
This is also only for 25 participants.
This new trail involves asking the 25 patients every single day. That wasn't the case in the original trial. It sounds like they are seeking more accuracy as to when the long covid symptoms actually diminish to zero. This might infer that a large number of the trialist that actually got the drug (not the placebo) and whom were asked questions at day 90 do not have long covid anymore .
FFS gggg21, calm down.
You know I’m long SNG and positive. I said I’ve obviously misunderstood and was asking genuine questions. Where does it say the US have asked for this? Again, not disputing any of this. Just interested to read it.
Doc, it is a quality control check of the OSCI methodology used in the trial is easy to understand for patients. Nothing iffy about it at all.
Also the end dates on these registers are arbitrary and movable as we have seen with SG018.
Wow, long covid, a huge bolt on for a few days extra for results. I'll take that gggg. Thanks for sharing.
a bit iffy? have a word , maybe the fda wanted this detail and info for sign off, this was started on 17th Nov....so they did not have the data then....iffy like heck!
I’ve obviously misunderstood how the trial would run and thought these questions would be asked as part of the original trial.
It says these are new questions, and “the data from these is being used to assess the primary endpoint in trial SG018”. Should they have therefore been asked before now? And, could this suggest the data analysed so far is a bit iffy and they need more evidence?
Finally, end date is 31st Jan, so presumably we will not get any RNS until after this date? Albeit it is only a few days away!
Cheers for sharing this, what a great find!
This is a great spot, thanks for posting.
Start date 17th Nov end date this month....last few patients asked to do further study....i wonder who asked for this.............
https://twitter.com/gggg2120/status/1486331285098401794 updated now ;)
Looks like ducks are being put in order....long covid