Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Precisely WPA
The trial data is already complete, done and dusted. You can’t go back and re-ask those 620 odd patients the questions again or reinterpret their answers. This is purely and exercise in convincing regulators any published results hold up to scrutiny.
If I'm reading this right and 25 patients were asked only 2 questions (assuming the patients themselves provided the answers and therefore not highly technical or medical data answers) this would hardly take 17/11 - 31/1, unless the 25 were shared across the 17 countries and no just US? As others have said, not really the sort of data that would align well with highly technical P3 data from medical professionals. More likely something extra asked by FDA to fast-track EUA. Bodes well for 31/1 I hope.
Ah. Yes it was well discussed at length by some of the most distinguished members of this board. Understand poly ramped up their buying in the days after it would to appear to have passed. If you scroll far enough back you should be able to find it. Example of this board at its best tbh.
@Brand, understood. But wasn't aware that they carried out a futility analysis.
To the best of my understanding, sprinter passed a futility analysis aproxx halfway through the trial. We don't know what level of efficacy was required to continue recruitment, however if the company had the bar high, they could have a strong indication no?
"But with trial end date as 31 Jan, we won’t hear for another possible few weeks while that’s analysed and added into press release etc?"
Waite, Its a 25 person QA study. It won't be part of the P3 results data release. It will be part of the data package provided to regulators for any EUA application. It certainly won't be holding back release of P3 data and it is very unlikely that we will ever see any of this data anywhere.
@Brand, Why would they carry out post-marketing requirements after a futility analysis?
Thank you for sharing GGGG
Marik
' If SNG have sight of top line data before this trial start, then this has positive implications, and if they don't have sight, it shows exceptional confidence in the product.'
So I think the options here are?
1. They had enough of a signal after the futility analysis
2. They were so bullish on success, they went for it blind
3. The trial completion date was actually weeks before the RNS for last patient recruited
Unless I've missed something?
It's positive news:
- as a minimum SNG have exceptional belief in the product on 17 Nov
- best scenario the results are positive (it's unlikely as it makes a huge assumption that SNG had visibility of data)
Either way, positive news with phase 3 results around the corner. Prepping up for EUA application!
Come to think of it though, if the people were anything like a certain person on this board, it might take 25 months
That was my hope too. But then there’s the wording and sign off etc
Great find ggg
Seems you could canvas 25 people on the understanding of 2 questions in a couple of days?
Brilliant find
But with trial end date as 31 Jan, we won’t hear for another possible few weeks while that’s analysed and added into press release etc?
Gggg, you said last time trial details up, RNS next day? But that end date ?
Yeh sorry for being all over the place and that lately, lots going on with work and business, blame the pre workout juice
Yes, great find gggg. Even if I am lacking some IQ to get my head around it all :)
I just wanted to know if this was positive, negative or neutral news. It seems from the comments that it’s more positive.
@BeContrarian, that would be correct. It is what would normally be required for NDA as post-marketing requirement. Here as we know the process is expedited and SNG will apply for EUA. If SNG have sight of top line data before this trial start, then this has positive implications, and if they don't have sight, it shows exceptional confidence in the product.
GLA
In addition: this 25 person trial started November 17, 2021 and the Synairgen announced completion of Phase III recruitment on Nov 11th. My assumption was that data would be unblinded mid-Dec. With that in mind, I would say that I'm more inclined to believe that SNG & Parexel will have added this extra part of SNG018 in readiness for EUA. Let's assume that they had no feedback from the Phase 3 or MAP or Phase 2 Activ-2. With the trial completion next Monday, it would make sense that Parexel and Synairgen are preparing to expedite the drug approval process following announcement of phase 3 results. I would assume phase 3 results are to be released very soon and EUA application submitted very soon after that.
Gggg
Many thanks, yet again.
Excellent contribution and, as you say, dotting the i’s and crossing the t’s.
GLA
With reference to Matml74's point on quality assurance the protocol does state that quality assurance audits may be conducted at anytime during or following the study.
Haha fair point hop! Been a dreamy week with him to be fair. Thought I’d take 5 to check in with you lot and wasn’t disappointed!
Take care all.
You should be asleep BC, not wasting spare time on here :) My two year old has just got his big boy bed but keeps joining me at about 2am. Makes me feel like I'm the most important man in the world but rubbish for sleep! Enjoy and 'soon' would be good!
These were the questions asked to the patients on a daily basis post discharge and up to and including day 35. They seem pretty robust and patient-centred to me.
After hospital discharge, patients should be asked the following questions about their clinical status and return to the pre-COVID level of activity:
- “In the past 24 hours, did you experience any signs or symptoms of your coronavirus infection?” “Yes” or “No” answer will be required.
- “In the past 24 hours, did you feel that your usual activities (e.g. work, study, housework, family or leisure activities) have returned to the level from before your coronavirus infection and did not require additional assistance/support*?” “Yes” or “No” answer will be required.
* assistance/support is defined as additional help of other people and/or requirement for supplemental oxygen (or a higher level of supplemental oxygen), compared to the pre-COVID state.
@BeContrarian, that would be correct. It is what would normally be required for NDA as post-marketing requirement. Here as we know the process is expedited and SNG will apply for EUA. If SNG have sight of top line data before this trial start, then this has positive implications, and if they don't have sight, it shows exceptional confidence in the product.
GLA
I’m thinking this might be more of an EUA thing rather than impacting on our readout? In which case results might be any day now.
They are always wrong those dates for 9 out of 10 trials, they just pick best guess dates.....first submitted to the site on 11th January but not publishing for 15 days is odd....usually a few days max between upload and publish.
Well remembered gggg21