Member Info for Fruitsnveg

Bumping this up.

Dafad, you could be onto something. Both Hvivo and Synairgen share a certain David Robert Norwood (past Hvivo, present Synairgen?). Reading today's Hvivo (owned by Open Orphan) RNS, it seems that it could be entirely 'plausible' that the UK Biotech they refer to is . . . . . . .

Any more thoughts on this please share here.

Very. Good. Spot. Dafad. !

Any more thoughts on this? Could it be....? Maybe barking up the wrong tree here but it certainly looks worthy of investigation...

Perhaps. But if that happens it would have to be on terms that better those of maintaining independence. If the drug performs in trial as we hope, there will be NO cheap seats in stalls for this production.

Some findings:

https://www.thehealthsite.com/news/diabetes-and-severe-covid-19-study-suggests-interferon-as-a-potential-therapy-837567/

Not at all cmww2014, but wrong thread :-)

JoeyD, I don't doubt that immunity conferred by getting Covid is superior to that conferred by a vaccine, and those stats you give prove it. But, without genetic testing, none of us know who amongst us, 'appear' very low-risk, but are in fact 'genetically predisposed' to being very high-risk to severe outcomes from Covid, or death. Therein lies the problem.

Very true wpa5, people forget too easily, falsely likening it to a bad dose of flu. They forget how badly and relentlessly it can ravage major organs. His story is very sobering.

Don't expect fixed dates and no delays for multi-location /billion dollar trials in the midst of a Pandemic, that's just unreasonable. Easy to forget this has never been done before.

Do you mean Tikvah Asset Management LLC Bruce? Different outfit I think.

Apologies I forgot to post link for that quote - it's here:
https://www.nbcbayarea.com/investigations/where-are-the-cures-for-covid-19/2656627/

In my last post, the NBC article linked to the study below, which Dr. Shafer (Stanford University) and a team of scientists have published - a comprehensive review of COVID-19 antiviral therapies, dd 28thJuly 2021.
It is an interesting article with a section on Interferons (including sng001), the conclusion particularly so, when you see how they are rating "inhaled IFN-ß" as a "promising treatment" next to the best:

"In conclusion, the main therapeutic advance during the pandemic has been the development of highly potent neutralizing MAbs for the prevention and treatment of SARS-CoV-2. The administration of remdesivir and possibly the early use of convalescent plasma may have a role in a subset of patients. Several additional treatments that appear promising based on small clinical trials, including molnupiravir, inhaled IFN-ß, and fluvoxamine. Other treatments have a compelling mechanism of action but are further behind in clinical development,...etc"

" Yet another drug uses a version of the human body’s natural immune defenses: interferon, to battle the coronavirus. It can be inhaled at home if someone suspects they’ve been exposed to the virus."

Published 3 hours ago so we're still in by the looks of things :-)

https://www.youtube.com/watch?v=yTruRiXVs-A
3.20 to 3.44
Thought this worth sharing, RM interview from 2017, as some, like me, may be interested in the COPD potential of SNG001 beyond Covid. It is partially my reason for investing here and I see it as , that may be similar for others too?

On COPD, RM was asked how the drug could be for COPD. His response => "If we're successful (in COPD) then this is a huge drug.... It could be billions, it really could be a blockbuster in COPD.
There is nothing these patients can take, that is going to help handle the virus (not referring to Corona but any other Winter virus). At the moment people take oral corticosteroids which are inexpensive, but not nice drugs to have to take regularly"

For info, of the biggies, GSK, AZ, Merck currently dominate in the COPD space.

You are having a laugh Woodstock.

My view is no news is good news, it means we remain. Every day a stronger case is made. You will hear pretty sharpish when we are kicked out.

Being prepared for loss is astute, depending on when you wish to exit.
For myself, the balance still leans a lot more towards success rather than failure. Potatoes, Pot-Ah-Toes....

Interesting.

Janet Wood**** (MD and Director of the FDA), wrote the following in the NJEM (New England Journal for Medicine) in November 2020. The co-written article "Bridging the Gap at Warp Speed — Delivering Options for Preventing and Treating Covid-19" stated 2 things that give me high confidence in manufacturing being much less of an issue than some here think. Firstly the intention:

"Predicting drug performance in a new disease is difficult. Many candidates may fail to demonstrate efficacy or have safety problems. It’s necessary, however, to take a financial risk early to scale up manufacturing in order to have drug supplies on hand if the results are positive. If we wait for clinical trial readouts before initiating large-scale manufacturing, developing an adequate supply could take months or years."

And further proof that this is their approach:

"OWS is tracking studies of immunomodulators in patients with Covid-19. If and when we detect positive signals, OWS will move to accelerate clinical development and invest at risk in manufacturing as appropriate."
Unless I'm mistaken SNG001 is a novel immuno-modulatory therapy, so the above would apply.

https://www.nejm.org/doi/full/10.1056/NEJMp2028535

Good stuff Ndn71.

Matterhorn,
I have to say, the 100,000 figure I give below might be accurate in our case, or it might not. Like I said, those guidance notes may have been updated for the Pandemic. A guesstimate at best. The ideal would be to have a Chemical /Pharma Manufacturing bod comment on this (there were a few on the BB in 2020 I think?), they would be better placed to comment on it than I.
BTW, I concur with the 100k per month figure, that too was my understanding.

Matterhorn,

"If it’s their aim to manufacture circa 1m doses per month then the question would be how much (i.e. doses) should they produce as part of a test run or runs to give them a sufficient level of confidence that they can pull off 1m doses per month."

Below is a link to an old "Note for Guidance on Process Validation" produced by the EMA back in 2001, where it states that 'pilot' batches (which, if you read the definition in pages 3/4 of the link below, seems to be what RM was talking about) should be 10% of production scale or 100,000 doses whichever is the larger. Pages 3 & 4 are where you need to look. I cannot find a more recent version if one exists, but I cannot imagine the standard pilot batch figure would have changed in 20 years. Up until recently the pharma world was somewhat of a dinosaur I imagine. It could however be that the FDA/Warp Speed guidelines of 20/21 stipulate a different amount due to the urgency of this pandemic, but I have not yet been able to wade through sufficiently to find a batch figure in their guidance. That's not to say it's not out there, I just have not found it, yet.
https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-process-validation_en.pdf