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“Medical products that may be considered for an EUA are those that "may be effective" to prevent, diagnose, or treat serious or life-threatening diseases”
I think some here may be applying full license criteria. The EUA guidance emphasis “may be effective”.
In my view SNG001 more than qualifies. Link below. Read for yourselves.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#criteria

I agree. See my previous posts for detailed analysis of why.
Reading the text if EUA requirements also gives cause for optimism. I just hope the company have the nerve for twin track approach.
1) EUA
2) Large platform trials in both IP and OP setting.
They are definitely keen on 2). I hope now they will push on with EUA

The 70% rrr referred to in my last post is with reference to todays RNS. Apologies for typo- this appears to refer to antivirals.

In considering the potential of SNG001 we need to look at the competition and how it came to be in common usage. We have relatively little info on out of hospital efficacy at present so we must confine ourselves to looking at in hospital therapies. I have posted here before on this issue.
1) dexamethasone. It took multiple trials over many thousands of patients and a meta-analysis to show efficacy in a subgroup. The main benefit is for those in critical care. At best 30% rrr (relative risk reduction for death).
2) IL6 antagonists. Again mixed results and subgroup analysis needed to show efficacy- again circa 30% rrr in those with CRPs> 175 ( crp is a marker of inflammation).
3) mabs - only work early in disease.
4) antivirals- don’t work in hospital- only efficacy is within 5 days of infection. 70% rrr

This is a strong result today in a population in whom the options are limited. I think we have as good a chance of EUA as many that are in routine use.
I’m holding having topped up in the dip.

Still not in the news but it looks as if there has been a big jump in hospitalisation, ICU and those on oxygen in SA.
I last checked this site 2-3 days ago and hospitalisation was 3k with circa 20% on oxygen or ventilation. Now 4.5k and circa 40% on oxygen or ventilation.
I haven’t yet been able to verify from other sources but if this is true the world must brace itself and prepare once again. This is driven by new omicron sublineages. I don’t recall as high a proportion as this needing O2/ventilation in omicron wave though. I’ll keep you updated if I find anything more.
Take care folks.

https://www.nicd.ac.za/diseases-a-z-index/disease-index-covid-19/surveillance-reports/daily-hospital-surveillance-datcov-report/

https://www.rechargenews.com/energy-transition/billionaire-forrest-s-ffi-needs-450gw-of-wind-and-solar-by-2030-to-meet-its-green-hydrogen-target/2-1-1215830
Plug are 50:50 with FFI on their manufacturing venture for electrolysers. If this story is to be believed the current accounted for electrolyser order book is the tip of the iceberg. It feels like we are at a turning point in hydrogen. Everything appears to be going exponential. Near daily news on upscaling, new applications and projected demand.
Interesting times.

Is this definitely related to JVs announced in Feb? If so it is potentially huge for ceres. Should we expect RNS tomorrow?

Thanks taskmaster. Good post.

Indeed frustrating that so close. Underpowered. If I am not mistaken the original plan was for over 800 patients. See this link below.
This may provide the a priori intention to pool results over the full trial populations. From a statistical perspective a prior intention to pool could be very important, rather than post hoc trawling if results to find a positive result in amongst negatives.

https://clinicaltrials.gov/ct2/show/NCT04385095

My bet is RNS on the morning of conference. Possibly before then. Once again worth watching daily if one can cope with the stress!

Re: LiamLiam question about change of dose. AZ changed dose after first 600 or so patients in their covid vaccine trial and proceeded to EUA.
Another query along the thread was about baseline use of oxygen in P2 and assuming similar use in both groups. For p2 there was greater percentage on oxygen in active v placebo (77% v 58%). This would have had the effect of bias against SNG. It would be entirely legitimate to adjust for imbalances in baseline data in any pooled or larger study. We’ll find out soon enough I hope.
In the meantime everyone on the board. I wish you all well.

Thanks Trinitiman. 100% agreed. Lined up against other covid therapeutics SNG stands head and shoulders above others that are in routine use. Steroids- probably only 40% relative risk reduction in critical care patients. It took several thousand patients and subgroup analysis to determine this. IL6 antagonists- similar.
If it takes subgroup analysis for SNG to demonstrate benefit it’s in good company but I suspect in terms of meangful benefit ie number needed to treat head and shoulders above the rest.
In pre-hospital patients time window will be bigger for SNG than other antivirals.
Frustrating that p3 was underpowered and with the wrong primary end points. Hindsight though is a wonderful thing. We all knew statistical significance on a 600pt trial was a tall order but the truth is that it still points towards strong benefit.
Keep the faith folks and look rigorously at the data. It’s all pointing one way.

If this plays out as Anybe4 suggests ie polygon wait and buy in 12 months at highest price over previous 12 months will we be forced to accept. My understanding is they would need 90% of the company to force the sellers. Is that correct?

I’m definitely holding and topping up. There is a clue from todays RNS and interview about the direction of the ongoing data analysis.
“the focus now is to stop deterioration in certain patients, an area where the trial indicated Synairgen’s candidate can have a benefit.”
I think stopping deterioration may be the angle that is supported by the evidence, potentially allowing examination of results across all the studies.
Stopping deterioration in the OP population ie admission.
Stopping deterioration in the IP population ie prevention of need for critical care or death.
Clue also from the RNS about subgroups that may benefit the most.
If SP drops much further I won’t be able to resist topping up, even though I’m in too deep as it is!

Thanks everyone. Sorted.

HSD- did you post a message about a new more lethal variant today? I would be interested to follow this up but have lost the post in amongst the post RNS excitement.

https://www.rechargenews.com/energy-transition/vattenfall-led-hydrogen-fuelled-green-steel-pilot-lands-160m-in-eu-grants/2-1-1195147

Those on this board will likely know if this is big news for NEL or old story.
NEL supplied 4.5MW electrolyser for 1st phase. It looks as if this is ramping up to 500MW electrolyser. No mention though of who will be supplying but NEL must be in a good position. Any thoughts ladies/gents?

Thanks Bilbo. Agreed. Could go either way; plug or ITM. ??

Hopefully RNS from itm to follow. ITM supplied electrolysers for first stage of this. Big, big new investment coming
https://www.rechargenews.com/energy-transition/fertiliser-maker-oci-to-buy-up-to-4gw-of-green-hydrogen-from-10gw-north2-offshore-wind-project/2-1-1194100

https://itm-power.com/news/opening-of-the-gasunie-1mw-green-hydrogen-electrolyser-plant-in-the-netherlands