The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Bumping this back up as the other thread this morning is boring and of no substance...
They also confirm why SNG took long to recruit on this trial.
On page 240:
SITES PARTICIPATING IN THE STUDY
Participation in phase II evaluations of this agent will be restricted to select US sites, due to
limited investigational agent/placebo supply.
If it takes so long to sign off should have gone to Specsavers
Yes it’s from June. We have known the V7 protocol was written up for a long time but was blocked from release for regulatory/ approval reasons
When was the new version of the protocol published. People are saying "from June" - does that mean it was published in June and if so why has no-one noticed until now?
Absolutely, fruits. I'm not counting the chickens yet, but seems nonsensical otherwise.
We are so nearly at the end game… we’ll know soon enough. I had this week down as the one we’d finally find out…either way. Maybe Monday.
I’m with Andybe4, I can’t believe it has taken this long and expect there has been something going on behind the scenes. I just hope it is positive!
Rumandpoker, I agree with you about releasing and publishing a draft. It's not done that way. To get a release drafted there would have to be a minimum review, which if you consider the interested parties names in the document, would have been a lot of very busy time-poor people. I can't see them officially reviewing a protocol that was just done 'on the off-chance Synairgen end up progressing'. That version wouldn't have been released, as you say it would be still parked on someone's hard drive. No doubt, it would be better to have absolute confirmation of that, but that's how I see it.
If the decision hasn't yet been made regarding A3 progression then why on earth release the protocol. If the document has simply been prepared preemptively as a matter of organisation then don't release it, keep it in some draft folder on Fauci's laptop. To release it, as opposed to storing it till judgment Day, seems a bit absurd otherwise
I Should just clarify:
It’s massive because Sprinter proves in a hospital setting the effectiveness of the drug up to 10 days or possible more after symptoms
If Activ2 succeeds it proves Synairgen in a pre-hospital home setting.
No other covid drug meets those two criteria
HAs to be news in the morning. Exciting times ahead.
Makes sense to me. Fine tuning. Focus on the patients it's known to work well on and by the time all the data is gathered, analysed and approved, doctors will know exactly who to prescribe the treatment to. Every hospital will need a supply.
My take on 1.3.14 is a conversation has clearly taken place between Activ2 and Synairgen and Activ2 have accepted the view that the subset of data Synairgen presented from their home trial does show a benefit, but not sufficiently significant because of the data size, which is exactly what ndn71 said the other day. It would seem they are prepared to give them an adequate sample population to demonstrate statistical significance amongst patient’s with more severe breathlessness.
This is massive, if the resulting data stands up.
This reads really well .
Yes it's not confirmation of P3 , but sure does elaborate on how they see SNG001 .
Allowing protocols to adapt to both the situation , and to focus on the strengths of the potential therapy would just seem like common sense to most people .
The sort of thing most SNG investors wished could have been arranged before the trials began .
Looks like it's actually being done now !
And if we are into phase 3 , I think it shows that they are keen to make the most of it , to glean data for where SNG001 is the best fit .
Sprinter will do the job anyway - but its great to see Activ2 being constructive rather than obstructive .
Hi Ndn, agreed but if you want to measure the impact on the breathless you have to select the poor devils in the first place!
Excellent post Cam. This is fundamental to what Synairgen have been pointing out and explains the delay from Dr Castro’s first comment to imminent confirmation of progression to P3.
Great news. Clearly they’re preparing for sng001 to move forward and unless something very strange comes out in the results it will move forward. They’re even going above and beyond in recognition of its impact on more severely breathless patients and in giving the drug every opportunity to succeed against its comparator with the larger sample size.
This really is a substantial recognition of SNG001 potential
Ndn, to me the difference here is key, noting the final few words in the June version:
From March:
1.3.14 Phase II: To determine whether SNG001 reduces severity of cough or shortness of
breath or difficulty breathing through study day 28
From June:
1.3.13 Phase II and III: To determine whether SNG001 reduces severity of shortness
of breath or difficulty breathing through study day 28.
1.3.14 Phase II and III: To determine whether SNG001 reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28 among individuals who report moderate to severe shortness of breath or difficulty breathing at day 0.
I get it now. As an inhalable, reducing breathlessness is likely to be one of SNG's strengths. So it would've been a considerable setback if they weren't actually measuring it.
pmjh - "I am delighted to see that Synairgen... will be taking in patients reporting breathlessness"
Thanks for clearing that up.
Ndn71 - "I’m saying we need to favour the symptomatic breathless to have the best chance of progressing from A2 to A3"
All the drug really needs to do is bring about some measurable improvement to progress. Why would breathlessness matter more than, say, hypoxia?
Page 240:
Phase II and III: To determine whether SNG001 reduces a COVID-19 Severity Ranking scale based on COVID-19-associated symptom burden (severity and duration), hospitalization, and death, through study day 28 among individuals who report moderate to severe shortness of breath or difficulty breathing at day 0.
@PMJH - do you read this as we are moving to A3 or we have already been given patients reporting breathlessness in A2?
Ndn71 - "The outcome isn’t the issue, it’s the 'in-come'”
I don't understand. Are you saying there's some doubt about whether breathlessness is measured before patients begin using the drug?
Anyone else think RM is giving us the wink - Couple of recent RNS for new appointments when previously no RNS for similar level appointments.
Twitter page has gone MENTAL with 4/5 tweets in last few weeks.
Thanking / acknowledging LTH for their long term suffering in yesterday's forum.
All of the above thinly veiled by RM as SNG Rocket is ready to launch.
Good luck everyone.
Doesn't page 266 confirm that breathlessness is an outcome they're measuring in Activ-2 phases two and three?
https://fnih.org/sites/default/files/2021-10/ACTIV-2_v7.0-wLOA%20073021.pdf