Member Info for Doc.Daneeka

So we finally arrive at something we can agree on.

Fyi - InflaRX is the company - Gohibic (vilobelimab) is the drug.

You should still have 3 to 4 times fewer patients reaching the point of intubation but there will be (potentially) 27% fewer deaths in the placebo group. Which will influence the readout by..... 27%. As I said it's only not influenced at all if prevention of intubation is the primary end point - which it might well be as days in ICU on intubation are the most expensive inpatient days there are.

Not sure how you're struggling with this Tommy. Obviously SNG will be trialed with SOC and placebo will also have SOC. The addition of another anti cytokine drug in the ventilated cohort of both arms will lead to fewer deaths and less time in hospital. That makes it more difficult to show a useful efficacy for SNG in hospitals.
Since SGO16 the changes have been huge - with mostly double and triple vaccinated populations ( except maybe in the good old boy deep south of the US ), strong community acquired protection from the whole world catching Omicron and significant improvements to SOC. Mabs worked against the much more dangerous Delta wave but have largely disappeared now, and the y were only in the outpatient setting anyway. Still space for SNG you'd hope for those most at risk but if new drugs are EUAd for inpatients that can't help its chances.

More significant is that having narrowly failed its P3, InfrRX managed to convince the FDA that the drug had sufficient merit based on post hoc analysis to warrant an EUA - which begs the question about what Synairgen were doing in the middle of last year and why they did not also make an application based on better post hoc data.
Doc - Wigster - Did anyone ask the question at the AGM ?

it doesn't matter at what point the drug is administered. What matters is whether patients have a better chance of survival with SNG and SOC or placebo and SOC. If there are fewer deaths at 28 days - and SOC now includes a second drug for ventilated patients and let's say 15-20% of those saved because of this new drug, then it obviously makes it more difficult for SNG to prove efficacy.
Unless you design a protocol which sets prevention of intubation as one of the main endpoint.

Dexa is not SOC for all Covid patients. Only those requiring supplemental oxygen.

It doesn't matter that the approval is for late stage patients - it will still impact results for drug and placebo. 27% fewer will die. Dexa is also a later stage intervention than SNG's Sprinter protocol - but it still ruined the trial

Quite right dippfs, and it's not just a case of "taking it into account" Given that any new trial will be targeted at the very patients who end up on ventilators, the new drug will have a fundamental affect on outcomes. SNG will be given earlier but the placebo arm will have an SOC of Dexa, Remdes and Vilobelimab/Gohibic,

Gohibic got the green light after a phase 3 twist. In the randomized PANAMO trial, Gohibic reduced the risk of death in the sickest patients by 27% compared with placebo during a 28-day period, according to data published in The Lancet Respiratory Medicine. That showing missed statistical significance on the trial’s primary endpoint. But on another predefined analysis and two post hoc analyses, the drug’s improvement was statistically significant.
Despite the mixed results, InflaRx talked to the FDA and applied for EUA last September.

https://www.fiercepharma.com/pharma/fda-authorizes-inflarxs-anti-inflammation-drug-most-serious-covid-despite-phase-3-miss

USA based Medical Affairs Director job makes much more sense for STRIVE than for any possible JV scenarios (J&J being the favourite tip ) They're looking for an all- rounder. A high quality science communicator. This would not be the job description if they were going into JV - where the requirements will be very specific - but it is necessary to keep an eye on the dozens of US trial sites and engage in all of the US conversations that will start as soon as the trial is announced.
It might also be the job description if they have nothing lined up whatsoever but are still hopeful someone will see the potential in SNG.

I'm not a fan generally of bothering the company, and have never done so personally, but if you're saying they'll engage meaningfully with investors just once a year, and we should accept that, I think it's pretty poor.

Take your point gunto, although Shionogi announced its involvement with STRIVE well ahead of FDA confirmation. As a general question it's one they ought to be able to answer, given that their stated goal at last year's AGM was to find a PT.
And the answer must be yes - even if they were knocked back.

Suggest we uptick TP's original post to show the company that quite a number of shareholders - on this bb anyway -support this viewpoint. They could reassure investors quite easily with an outline of what they have been doing or hope to do in the future, without giving away anything sensitive.
Personally I'd like an answer to just one question. Have they applied for, or been in discussions with NIH in relation to, a place on STRIVE ?

Great quote Aether - he goes on to say "The sciences, each straining in its own direction, have hitherto harmed us little; but some day the piecing together of dissociated knowledge will open up such terrifying vistas of reality, and of our frightful position therein, that we shall either go mad from the revelation or flee from the deadly light into the peace and safety of a new dark age. "

Which sounds like us now - having suddenly realised that AI is already smarter than we are and capable of subjective emotional responses, and trying to find a way to switch it off.

Lemme know if I can report this for you Mani. With a bit of luck the mods will get rid of it before they've taken the covers off in the morning and you'll be able to start the week with a clean slate.

Not many on this bb qualified to interpret the full dataset from Sprinter - certainly not qualified enough anyway to take issue with the company's own peer reviewed analysis I'm certainly not one of them, and based on about 8530 of your 8537 posts Mani - you're not either.
Which isn't to be unpleasant but just to encourage you to leave this where it is, and refocus back on all the other stuff you're unhappy about.
You came late to the post Sprinter spleen-venting party - most of us got it up and out of the way a long while ago.

Hopefully this signals a return to the eminently achievable Covid -19 goal revealed in the Sprinter deep dive and presented at last year's ATS
"These analyses showed stronger treatment effects with SNG001 in these high-risk patient sub-groups, with the strongest effect observed in those who had clinical signs of compromised respiratory function. In these patients, who represented approximately one-third of the SPRINTER trial population, SNG001 significantly reduced the risk of progression to severe disease and death compared to placebo by 70% in the Per Protocol population (Odds Ratio (95% Confidence Interval) 0.23 (0.06, 0.98); p=0.046). "

Difficult to see why they would return en masse this year to present exactly the same data again ( albeit with a greatest hits consideration of SG016 and ACTIV 2 at the same time ) unless they have re-commited to finishing the Covid job - and even have grounds to believe there's a trial to help achieve this.
I'm not a big joiner of dots - but there's enough circumstantial evidence here that says something may be afoot.

https://www.synairgen.com/media/synairgen-presents-at-ats-2022

I'm sure that's wrong Mani. Jonny is correct about AOI#16
and this is the broad description of DRIVe
" BARDA may award contracts to promote innovation in technologies that may
assist research and development with respect to products that are or may become a qualified
countermeasure or qualified pandemic and epidemic product and approaches for public health
emergencies "
Pandemics are caused by viruses

Non-responsive / out-of-scope topics:
• Proposals focusing on influenza and SARS-CoV-2.

where does it say this Mani ?

More great work Titania. Good news if there's a second possible FDA route forward. And one that puts Rick Bright back in the spotlight.
Funding is in 2 parts though and not between $750k and $20m. $750k is the maximum initial award. The BAA+ Phase funding of up to $20m can only be accessed as a follow on from the initial BAA award of $750k, and based on the success of whatever work was funded initially. Which is a structural limitation for a drug such as SNG001 that's already have 10s of millions spent in trials. But could still be a route forward if a small multi-virus trial using JV funding and Barda's $750k does enough to unlock the greater prize ?
It would be long and slow route forward and if we're already in a JV at this point you might prefer the partner to stump up enough cash to just crack on with a big multi-virus trial.

The path from UNIVERSAL to a significant trial or trials is a lot longer and more complicated than the path from Sprinter to proving statistical significance for Covid inpatients would have been. Years longer.

Scinv - while you're here. Forget about the "he said - she said" for a moment, and give us an appraisal of the merits or otherwise of SNG001. You don't believe in the company, but do you see a future for the drug in the right hands. Presumably you did, at some point, believe in it. ?