Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
PMJH, it would be well deserved to hang up your keyboard. Your research here has been outstanding- detailed, well sourced and credible. I think you have kept many people invested here when the news was slow and we all required patience. Sincerely, thank you.
Great article Chris! The possibilities here are mind blowing. If Biden is talking today, that means Activ2 may be announced this afternoon or after markets close today. Fab Friday anyone??
Morning all,
Now we can see clearly that SNG are on Activ2, I have revisited Dr Jha’s senate testimony to see what else he said. The quote is:
“New antivirals are also being developed for mild outpatient cases, including MK-4482 from Merck and Synairgen’s SNG001. These have been facilitated by Operation Warp Speed and the NIH’s ACTIV-2 (Adaptive Platforms Treatment Trial for Outpatients with COVID-19) trials”
Activ2 is clearly in there and we have verified that through multiple sources. I’m wondering what else it means? This is speculation only for intelligent discussion.
So for SNG to get on Activ2, the US must be confident that they have secured supply of SNG in large enough quantities to make it worthwhile. That means they probably have a conditional preorder agreed with SNG (conditional on good Activ2 results).
In other cases where a EUA has been granted off the back of Activ2, operation warpspeed has either helped manufacturing or given a hefty guaranteed order to give the company confidence to produce at scale. I think this may be a possibility for us.
Here’s two examples of the sort of support that warpspeed can give covid drugs with EUA:
October 9: HHS announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company's COVID-19 investigational product AZD7442, a ****tail of two monoclonal antibodies, that may help treat or prevent COVID-19. The goal of AstraZeneca's partnership with the U.S. Government is to develop a monoclonal antibody ****tail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.
October 28: HHS announced a $375 million agreement with Eli Lilly and Company to purchase the first doses of the company's COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555. Bamlanivimab currently is being evaluated in Phase 3 clinical trials funded by Eli Lilly, in addition to clinical trials as part of the ACTIV public-private partnership. The FDA is reviewing bamlanivimab as a possible treatment for COVID-19 in outpatients. Monoclonal antibodies, which mimic the human immune system, bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.“
There is huge possibility here for SNG to get some major help. Hold onto tight to your shares!
Source for op warpspeed- this Whole page is worth a read. Worth noting this was Trump’s project, but sure Biden will be as eager to fund treatments that work.
https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
Hi Tricky, good question. Warpspeed is the finding behind the USA covid effort, so they fund the Activ2 trials. The announcement we are all waiting for is to say we are on Activ2 and that will rocket this share price.
Dada’s and PMJH - excellent research finding this video. Here is a transcript for anyone who has not seen it...
Activ2
Three new drugs:
“ 1) an Oral agent - chemostat - not high risk patients
2) Intra muscular injection - combination of monoclonal antibodies
3) Inhaled agent - an inhaled agent, a nebulised interferon beta, which may augment our response to viruses, protect us or treat us in respiratory viral infections
It’s actually reuse of something that’s been around for many years so it’s going to be interesting. It could potentially augment how you fight off an infection and perhaps prevent these long term complications that we’ve been seeing.
The interferon if you are able to get that study going sounds exciting, we really believe that some of the initial phases of the viral infection is able to decrease our interferon or anti viral responses so I think that maybe giving that at the right it could certainly help to augment some of that disease”
This is all we need to know we are backed by the US government and operation warpspeed. Amazing. This will set the share price off like a rocket when it is formally announced. Make sure you have done your top ups!
It’s amusing how the derampers appear just before news.
To the intelligent, civil people on this board... please ignore the idiots. They have taken over tonight. Filter or just don’t reply. They are trying to wind you up or trapped shorters who fear that news will land anytime. Because it will.
Have a good evening all!
Good point Jakman.
It’s concerning that only 2-3% of the patients were previous covid sufferers. A large number of people will have had covid by the time they have the jab. Seems a worthy safety issue to check.
The answer is we don’t know what the delay is.
We know something is going on that has disrupted the trial start they first thought. It could be mundane bureaucracy or it could be something bigger (good or bad).
What we do know is that polar wouldn’t spend approx £4m on even more shares without satisfying themselves that everything was fine or better...
Put the kettle on and relax. As long as the big boys are chilled, all is fine.
Morning All,
Tatty, I wanted to respond to your comments about the placebo group in the double blind trial. Placebo is still “standard of care” ie what they are currently doing to treat people not on the trial. So if you do get the placebo and not SNG001, you are no worse off than not being on the trial. Yet these people help the drug get approved for all. I understand your point about people not dying when we have sng001, but that’s the risk for the 23,000 people currently in hospital. If we can get 600 of them to go through this trial (internationally) then we can get EUA and get this out.
Hi fifi,
Sorry I wasn’t ignoring you on the link for Fauci’s mouth comment, I can’t remember where it was. It was in a Q&A session at the end of a Fauci interview. I have been stalking him and I can’t remember which one it was. I would guess it was one of the Jama network interviews with him on YouTube, but I can’t remember which one. It stuck in my mind because I thought he was moving Activ2 away from the previous Lilly treatment that was an IV infusion. The context of his comments was about finding an early home treatment and they wanted something that patients could self administer at home, not IV. Sorry I can’t give you an actual link. If I come across it again I will post.
Understand your professional view on tablets and respect that.
Fingers crossed we will know for certain this week.
For new investors reading along, here’s a summary of the available evidence that SNG001 is on Activ2 (a US government funded home trial that trials drugs for effectiveness and then quick EUA if positive results.)
1) Dr Jha (Dean of public Health at brown uni) gave evidence to the senate committee that SNG are on the Activ2 trial:
“ New antivirals are also being developed for mild outpatient cases, including MK-4482 from Merck and Synairgen’s SNG001. These have been facilitated by Operation Warp Speed and the NIH’s ACTIV-2 (Adaptive Platforms Treatment Trial for Outpatients with COVID-19) trials.”
2)This is backed up by SNG’s Prof Holgate who said that the FDA has asked SNG to run a “USA home trial”. Would be strange that the FDA request it, but don’t include SNG on their trial
3)Activ2 has increased recruitment advertising. They currently have no drugs in the trial, but this weekend they talked about new treatment plans, so it is imminent. Activ2 generates an extraordinary amount of publicity and uses 86 hospital/research sites across the US.
Senate evidence (page 3):
https://www.hsgac.senate.gov/imo/media/doc/Testimony-Jha-2020-11-19.pdf
Prof Holgate talking about FDA requesting a home trial for SNG:
https://www.reddit.com/r/synairgen/comments/k1ajol/update_on_the_sng001_drug_an_inf%CE%B2_therapy_for/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
Activ2 trial:
https://www.riseabovecovid.org/en/about-us/
https://www.nih.gov/research-training/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials
Active recruitment and new treatments added:
https://youtu.be/_SYhx4AZCy8
Remember your previous posts ElSol and worth a read anyone who missed it.
The p3 trial will be powered to give clear data on mortality, we were so close during p2 this time we should have large enough sample.