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HSD - Yes we are certainly a good fit from an outsiders perspective hopefully early September holds true.
Thanks Ghia. It'll be interesting to see what happens with the upcoming NIH trial and the data we're waiting for.
In P2 they added a comment regarding breathlessness as part of their “things to look at” which was a nod to the results from our combined hospital / home trial data where we showed our drug had more impact in breathless patients. The famous “like a fire to put out “ phrase. But in reality the patients for every drug on activ2 had the same
Profiles. In other words we didn’t get special breathlessness patients compared to any other seug
Phase 2 primary endpoint was all about viral load and reduction in time to hospital discharge
The primary endpoint became secondary and the secondary from phase 2 became primary
The result being death or severe outcome became primary for phase 3 which is where our drug shines (responder group)
HSD - I’m pretty sure the Phase 3 protocol was adjusted to have more favourable end points for a therapeutic that was broad spectrum can anyone remember the conversation around this and the update of the trial register?
At the time this happened it seemed to imply they liked what they saw from SNG but that it was touch and go on endpoints in the P2
He certainly wasn't one of the ones on the top table and I don't recall seeing him anywhere else in the room, although it is possible I missed him.
Wigster
Was he at the AGM?
He's more than welcome to demonstrate to us how exceptional he is for Synairgen as far as I'm concerned.
If this company is finished is this exceptional guy going to hang around ? Almost forgotten about him makes me think he must be champing at the bit
https://uk.linkedin.com/in/richard-hennings-17252338
The market doesn't think so (or the main II or directors).
The stock is finished. The treatments Sng001 failed in end point trials.
The important thing to remember is our participation on Activ was a phase 2 trial. It was meant to prove effect according to the standards set out in the protocol.
Phase 3 is meant to prove the effect in a wider population for authorisation.
Phase 2 is more evidence on the route to a commercial drug
You guys are right.
If it missed its endpoints in the Activ-2 trial it would have been stupid to waste more time on it (even if their 'deep-dive' data offered encouraging hints it was worth further investigation).
you haven't answered the question I posed earlier Tommy - and it's quite important.
"Strive will only enrol 1 drug at its initiation with other drugs to follow "
Is this an opinion based on previous trialing patterns, or something we missed in the Stacey Adam presentation. ?
I'm not sure how they would 'know it works' if the results suggested otherwise?
No, I suspect it was evidence based and they saw enough in the trial results to pass into into phase 3.
Any way, time will tell.
GLA
I should add progression to phase 3 is NOT
We think like investors it may work!
Clear and measurable virology and clinical data points decide progression to phase 3
If you read the Activ 2 protocol there are 2 clear routes to progressing from phase 2 to phase 3.
Whichever of those routes is the reason we progressed, its a significant pointer to our drugs effectiveness and we are one of a tiny number of drugs to have progressed and remain standing.
It’s also quite interesting if you read between the lines of the FDA decision process when considering drugs. Amongst the reasoning in FDA decisions they quote.
Evidence from multiple trial sources
Evidence of mechanism of action.
Through various trials, analysis Synairgen continue to add to the data and evidence for SNG001. No doubt the presentations at world leading events are designed to further that goal.
HDS
Another drug was terminated from the programme, so they have a reason to keep
us, surely if your theory is correct then all drugs would have progressed to P3?
Size82 - "they've have already announced it has passed into phase 3 so that would suggest otherwise...."
No it wouldn't. It would mean they have the same opinion as the investors: i.e. it works but the trial was unable to prove it due to the changable nature of the virus and its treatments.
HDS
SPRINTER did not meet the endpoints but the Deep Dive Data was compelling....
Size82... I think that is a fair assumption...Most likely right!
GLA!
HSD, they've have already announced it has passed into phase 3 so that would suggest otherwise....
More plausible is that they've been holding the release of Activ 2 data back as the Activ programme was put on hold, possibly to be revamped and due to fundingissues. The rise of Omicron was also muted as an issue.
IMO I doubt the US would release data until they're ready to progress. All about staying at the front of the queue. Why release the data and allow Synairgen to use it to jump on a platform trial in a different country. A bit of a cynical view but it's all about interests.
Looked at ADVFN for the first time a couple of weeks ago. shoots101 treats it as his personal pulpit to address the conversations we have on here. Which is pretty risible. Nobody bothers responding. It's not a serious space.
I suspect they're holding back the Activ-2 results because, like Sprinter, they're inconclusive and they don't want to destroy the development of a drug they think has real potential.
I don't normally go in for silly conspiracy theories, but I think that makes more sense than assuming they're just dragging their heels in getting the data analysed. They've already done the hard part and were confident enough with what they saw to recommend it advance to the next stage. With the enormous amounts of time and money that have gone into these trials, analysing data they've already got would be a walk in the park.
He isn’t the only person talking to Stacey. He is however the only person who decides to plaster correspondence on an open forum. I agree that the email gives nothing away. My concern is how he is now using the email to suggest not only that SNG are on the trial but also to tell everyone that it is a great buying opportunity.
So considering others are in touch, I will wait for further clarification.