I’ve slightly lost the thread here but my original point was that ronapreve doesn’t work on omicron and their protocol allows changes with a lesser burden of statistical evidence than would full FDA approval. There could therefore be positive news for SNG long before the trial is due to complete. If Sprinter successful and EUA granted for in hospital use it won’t be long until pre-hospital approval follows.
There is a potential big boost around the corner. In ACTIV2 the standard of care against which SNG and all the other mabs are judged is ronapreve. The omicron wave is breaking across USA with high hospitalisation rates. Ronapreve doesn’t work against omicron (it is no longer used by clinicians in uk unless proven non-omicron) and most other mabs have very little efficacy. The adaptive design of ACTIV2 builds regular data safety monitoring. Page 29 of the protocol suggests that agents “if demonstrating non-inferiority, inferiority or superiority” would result in “early termination or modification” of the study. This is on page 29 & 81 of the master protocol below. I think there DSM board will be looking very carefully at the data and SNG could easily end up in the hot seat in place of ronapreve. If recruitment is rapid that news could break in the next 6-12 weeks.
RE: wake up to this! NY hospital suspends 2 MABS (omicron).20 Dec 2021 09:27
Already in the uk we are preparing to stop using ronapreve for omicron. Labs starting to report a-gene drop out (a marker for omicron) from today. GSKs monoclonal retains some efficacy but supplies likely very limited. All hopes pinned on p3 for in hospital treatment.
I suspect in the UK we will stop using ronapreve for omicron im the next few days, due to lack of beneficial effect. If P3 in positive that will leave SNG as only serious option for in hospital treatment of omicron. Dexamethasone and IL-6 antagonists only of marginal benefit.
RE: MASSIVE JUMP IN CASES! 78610 positive today!15 Dec 2021 16:20
Data from SA may be difficult to interpret as big differences in age and vaccinations. One metric that is slightly concerning and going the wrong way rapidly is number of health care workers in hospital with covid 19. This has gone from zero to 2% of all hospitalisations in a matter of 5 days. The all time rate is 3%. If health workers have high rates of vaccination (as one would expect) thus is bad news in the making. Fingers crossed for P3 readout soon. A new paradigm in covid therapy.
In Scotland we are already in the worst case scenario modelling for omicron. Worst case model from 4 days ago suggested 5000 new covid infections daily by 17th. We had 5000 today. By 20th December 15000 daily infections in Scotland predicted in worst scenario. There is a serious possibility the actuality could be worse than the worst case modelling if todays numbers are representative of the curve. Let’s hope it proves to be a mild illness. Omicron is here. Let’s hope also SNG001 proves as good in P3 as in P2 and that manufacturing can be activated quickly. We might need a good proportion of RMs planned for 100k monthly doses here in Scotland.
RE: Merck pill shows reduced efficacy26 Nov 2021 14:39
I posted at the time that the hospitalisation rate in placebo group looked unusually high at 14%. If I were reviewing at mhra or fda I would be looking for more data. Not much better than placebo for the second cohort of 700. Further investigation needed I think. It looks like it the high placebo hospitalisation that is driving the top line results…..
RE: Nel Hydrogen & Wood MacKenzie deal25 Nov 2021 21:10
Hi major. Another great post. The techradar report from wood Mckenzie makes interesting reading. I think their point is well made- supply of green h2 accelerating. NEL and other electrolyser manufacturers clear beneficiaries. In parallel demand side needs to accelerate. I’m not sure if the evidence on that front is quite as clear yet but some very positive sign eg. JCBs commitment in heavy engineering. NELs deal you posted today very positive too. No clear direction yet for bus companies. Rail and marine still in relatively early stages. I have to say friends of the Earth’s comments on the whitelee green hydrogen project in Glasgow deeply unhelpful. They should 100% support greening of energy supply. Markets and engineers will decide how best it should be deployed.