Member Info for glenonholiday

Hi Stevev,

Really helpful post. Only part I'd disagree with is number 6. There's no reason for NCYT to not supply individual NHS trusts. They're separate legal entities from the DoH. I'd be extremely surprised if NCYT would not supply a hospital. I'd expect any refused sales might relate to central labs which are procured through DoH.

https://twitter.com/BBCNewsnight/status/1403420291926220807

Looks like its being covered on Newsnight.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innova-medical-group-inc-614819-06102021

https://www.shortics.com/novacyt?

The 3rd shorter at 0.48% has disappeared. Can't recall who it was I'm afraid, but seems good news?

EUA would be specific to use case. Home use much more likely to come first in my view off the back of P2 published results in mid to late March combined with Activ 2 P2 results slightly later.

Hi Andy, love your post and the honesty. If the good news does come in, I hope people will share their stories in a similar way. We'll have been through quite a ride by then. All the best to everyone.

Absolute nonsense.

I try to keep my filter list as low as possible. I've added Scinv previously but taken him off because there's obviously an intelligent person behind the posts and some criticism can be helpful balance.

But for the past few months its been misery on misery on misery. There are no new points being made any more - price point isn't realistic, patents are meaningless, CEO is corrupt / incompetent. There is no reaction to new developments, it's just old topics which have been argued to death.

I've had enough so will be adding to the filter list. Scinv, it can't be enjoyable coming on here and arguing with everybody. Please just have a think about how you come across, because I'm sure you blame others for their reactions, but it really is your arrogant style of writing as much as your one-sided challenges.

https://fnih.org/sites/default/files/final/activ-2.pdf

Some relevant parts:

The trial is a randomized, blinded, controlled adaptive platform that
allows agents to be added and dropped during the course of the study
for efficient testing of new agents against placebo within the same trial
infrastructure. When two or more new agents are being tested
concurrently, the same placebo will be used, if feasible.

Unblinded trial data will be provided to the Data and Safety Monitoring
Board (DSMB) for interim analyses. 2. Unblinded trial data will also be provided to the
DSMB after Day 28 data have been generated for it to assess Phase II graduation rules.
Unblinded Day 28 data will also be provided to a small group of people from the
company who owns the investigational agent. The small company group will not be
allowed to share unblinded trial data outside of their group, per a clinical trial agreement.
The rationale for sharing unblinded trial data to the small company group is to assist the
company in deciding if their investigational agent should move into phase III evaluation
or choosing a dose of their investigational agent to move into phase III. 3. The DSMB will
report these graduation rules and safety to NIAID, as the trial sponsor, and then the
NIAID will report these DSMB evaluations to the TOC. 4. The company will engage with
the TOC about their agent’s evaluation. 5. In conjunction with the company, the TOC will
then decide whether an investigational agent enters into phase III.

39.7m total so far. The UK actually looks quite impressive here, 300,000 vaccinations per day, and 6% of the population so far. But this does paint a picture that was to be expected. Vaccination numbers ramping up to impressive numbers, but a 7 billion population, such a huge task, and numbers by country will vary hugely. And I'm expecting at some point in perhaps a few months that production will fall significantly behind approval and demand.

Apologies for the format, I'm just copying and pasting from the bloomberg tracker. BY my calculation we're at about 0.5% of the world population. A daunting task...

https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/

Numbers are the number of vaccinations, the %, and latest update date.

U.S. 13,670,710 4.16 Jan. 16
China 9,000,000 0.64 Jan. 08
EU 4,839,920 1.09 Jan. 15
U.K. 4,006,440 6.00 Jan. 16
Israel 2,271,699 25.10 Jan. 16
U.A.E. 1,797,926 16.73 Jan. 16
Russia* 1,500,000 1.02 Jan. 11
Italy 1,118,594 1.85 Jan. 16
Germany 1,048,160 1.26 Jan. 16
Spain 768,950 1.65 Jan. 15
Turkey 678,460 0.82 Jan. 16
Canada 537,663 1.43 Jan. 16
Poland 436,963 1.15 Jan. 16
France 413,046 0.64 Jan. 16
Mexico 329,983 0.26 Jan. 14
Argentina 200,759 0.45 Jan. 15
Romania 196,090 1.01 Jan. 16
Saudi Arabia 178,337 0.52 Jan. 12
India 165,714 0.01 Jan. 16
Denmark 162,333 2.80 Jan. 16

Would be nice if people didn't send childish "told you so" responses alongside #SNG.

Not 100% sure on clinical trials but people generally aren't aware of the powers you have to direct your doctor on how you want to be treated. The main example of this is that if you require specific treatment, you can choose where you receive that care and the doctor must facilitate it. If you want a hip op in the Isles of Scilly, you can demand it, however reluctant the doctor is, and however stupid it would be! This has been true for getting on for 10 years - I know because I worked in health regulation previously. Feels like participation on a clinical trial would be similar. I understand that doctors are under a lot of strain, but would suggest pushing hard if any of you are in a similar situation.

Bravo Dudio, very welcome to get more views on this. Really helpful to get the second dataset on comorbidity mortality rates. Thanks for digging.

Thanks Mat. So my interpretation would be:

slightly higher risk in placebo for comorbidities, male/female split
slightly higher risk in SNG001 group for disease severity,
very equally matched for ethnicity and age (not exact but very close)

I've also been thinking about whether I should worry about the possibility of there having been a handful of very ill patients in placebo with a number of comorbidities. It's possible that this was the case, but if it was, it might go some way to explain the deaths in the study, but then given the overall favourable results of SNG001, it would suggest that in all the other patients, the differences between placebo and SNG001 were very strong. Not sure if I've made myself clear there.

My overall point really is that while I totally get the need for statistical significance in these studies, you can take a great degree of confidence from the direction of the results, which are positive in every aspect of the study that I can see - improved condition, development to severe disease or death, time to and likelihood of discharge, breathlessness and cough.

Areas most open to question seem to relate to balance on comorbidities, and on results relating to discharge. That for me is where I need to make a judgement, but the evidence seems strong in a very general sense.

https://ourworldindata.org/mortality-risk-covid#case-fatality-rate-of-covid-19-by-preexisting-health-conditions

This is a data source I found for mortality by pre-existing condition by the way. May be where Mat got his numbers from, they're consistent.

A question for me on the comorbidities is how they're distributed. We have summary numbers - e.g. 18 with hypertension, etc. What we don't know is how the comorbidities were concentrated on specific individuals. My question would be were there individuals in the placebo group who had multiple comorbidities - cardiovascular disease and diabetes, etc. If there were a handful of patients in this situation, this could go some way to explaining the mortality numbers. Do we know if individual data is available?

Nice post Mat, not a lot of constructive posts over the past few days. I'll be revisiting the P2 results, and I'd suggest anybody with a significant investment to do the same. The more views on them, reviewed with a critical eye, the better.

Ok guys, I'll help out where I can with a bit of web research.

https://www.wattpad.com/story/59082575-the-planet-zargon#:~:text=Zargon%20is%20a%20planet%20that%20has%20green%20tree,twelve%2C%20and%20my%20new%20parents%20were%20so%20nice.

"Zargon is a planet that has green tree stumps, and purple leaves, the animals are all rainbow coloured. The best planet ever." It seems to me that a man of Bill Gates' wealth could very well choose to live in such a place. But please DYOR. I wouldn't say the source is watertight.

I'll move onto the question of whether Bill Gates is reptilian next, expecting more content to review. Will get back to you.

We're running at about 2,000 patients admitted to hospital every day at the moment, and there's no obvious reason why this would reduce sadly. There's about 160 acute hospitals in the country, so approaching 15 patients per hospital. Research / trial hospitals would be the larger hospitals so could be 25 new patients per day per participating hospital. Even conservatively there would be 10 hospitals participating (aim was 20 I believe). So 250+ patients each day just in the UK potentially.

But then there are competing trials and there is the fact that the hospitals will be very busy places at the moment and not all opportunities to join the trial will be taken.

I agree, it does seem that much higher than 10 patients per day should be possible, especially when additional countries are added. But my nagging feeling is that its one thing to build things up from a number of patients per day, but when you look at it as a whole, completely filling a 600 patient trial in 2 months still seems tough. Likely getting countries up and running will be the bulk of the time. Once they're going the numbers should fill quickly.