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I went to covidvaccinestudy.com, the Pfizer enrollment site, and entered my wife and I, but the site listed Boston as the nearest location, 150 miles away from us in Westchester. There are several much closer sites shown in clinicaltrials.gov, including NYU Langone in NYC and one in Binghampton.
This string of tweets/questions about the Moderna phase III trial starts with the statement:
I have questions:
— C. Michael Gibson MD (@CMichaelGibson) July 27, 2020
1. The follow-up is 2 years after the 2cd dose in the Moderna trial. You cannot enroll if you plan to get another vaccine.
If I get randomized to placebo, & the drug gets approved, will the blind be broken at that time & will I be told I got placebo?
<<Heard some vaccine "firsteres" are signing up to be guinea pigs, on theory they will be first to get the vaccination earlier than ordinary "Joes">>
I may misunderstand your statement, but there is a 50% chance of saline placebo. Is the suggestion that they will allow preferential "cross-over" to the vaccine in that case at some point in the future, presumably, ahead of the general public?
This tweet discusses a Chinese study using a different nebulized type 1 ifn.
Encouraging new data for early interferon therapy for #COVID19 for association with improved survival https://t.co/ermYrKPngD @cellhostmicrobe retrospective multicenter study with > 200 patients treated, opposite results with later therapy (reverse dexamethasone look) pic.twitter.com/T2Vi6VCrnt
— Eric Topol (@EricTopol) July 22, 2020
As I read it, FDA guidance allows the primary endpoint to be EITHER COVID-19 (the disease) or infection:
It's confusing, "serious" is not the same as "severe." Likely there are better sources, but
<<Ugur Sahin… "it could take a decade to beat Covid-19">>
That follows from this belief:
This calculation from the article seems flawed:
I don't know the answer to your question or whether the two injections can't be done at the same time. What I found a bit confusing are the statements referring to "in at least one treatment group." There were four doses, 12, 16, 24, or 30 units, so we can assume that the favorable results did not occur in all four groups. Presumably they didn't just occur in the highest, otherwise they would have said that, but we can't be sure. They do state that at one measurement was dose dependent but didn't repeat that for all results.
Tesla's latest chip is incredibly powerful. https://cleantechnica.com/2019/06/15/teslas-new-hw3-self-driving-computer-its-a-beast-cleantechnica-deep-dive/#:~:text=Tesla's%20HW2%20is%20powered%20by,is%20capable%20of%2021%20TOPS.
They are retrofitting this into older models like our 2018 but we are still waiting
Up more than 4% on decent volume on a fairly negative day (attributed to bad coronavirus news, no less). I don't see any news.
I don’t know what you had in mind but for me, Daxi recalls Jadzia Dax. I always found her attractive, if you like aliens.
https://en.m.wikipedia.org/wiki/Jadzia_Dax
<<Since there are so many antibodies, how do they know that the antibodies created by their vaccines are indeed effective against the virus?>>
I don't think they do know. That's why, for example, Moderna is running a 30,000 patient study, primary endpoint will be prevention of symptomatic COVID-19 disease by comparing the rate of disease in those receiving the vaccine to those receiving placebo.
My uninformed observation is there are two Genetech trials, one is Actemra Plus Rem v. control arm of Rem, the other (started in late March) is Actemra + SOC v. SOC.
Seems like with the first trial, you are guaranteed Rem but would have no chance of dexa (unless they modify the trial due to the dexa news), and only a 50% chance of Actemra, whereas with the March trial, it depends on what SOC is. Has it really become Rem + dexa in appropriate cases that quickly?
Yes, I see there is a complex corporate history. Theravance spun off the development side of its business by distributing out a dividend of Theravance Biopharma shares in 2014, later Theravance (holding royalty rights) changed its name to Innoviva
If taxes are deferred, it would likely be UK taxes, since GSK is a UK corporation and I have no reason to think they would own a minority position in a US subsidiary. Still, taxes are taxes and what you say is logical. FYI, at one point in the not-too-distant past, they owned 25 million shares (as opposed to the 10 million or so they own now). https://us.gsk.com/en-us/media/press-releases/glaxosmithkline-to-increase-its-ownership-in-theravance/
So I guess they have been lightening up for a while.
Sensitivity, specificity, ppv etc. Nice interactive chart showing false positives, negatives, etc. as you vary the sensivity and specificity
https://www.wsj.com/articles/tested-positive-for-coronavirus-antibodies-dont-let-your-guard-down-11591794007?mod=cxrecs_join#cxrecs_s
<<i.e. Community immunity was established and the NYC population is now relatively safe>>
Last news I saw was that serology testing indicated about 20 percent of NYC residents have been infected. If true, they seem pretty far from herd immunity.
<<Last mile was always behind the curve>>
Back in days of yore, I made a nice profit on WinStar communications, which tried to solve the last mile problem with wireless point to point, exiting before it blew up (together with Lucent) and filed for bankruptcy.
The burp up to 6.47 subsided and backed down to 4.5, still up nicely on a percentage basis.
<<What is subjective about that?>>?
<<Galderma/Dysport are the same>>
Exactly. So the new data you are referring to is a subjective study of a 100 patients who say they were happy the results of two injections per year, as opposed to the actual information in their old package insert, which is grossly inferior to DAXI results.
<<The Dysport data released last week...>>
You mean the results of the Galderma study that biotech_researcher referenced here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155573271?
That data reports from a study that "Results showed that 95% of participants (90% female) were highly satisfied with the twice-yearly treatment schedule."
I can tell you that 100% of the people in my study were highly satisfied with my appearance with ZERO injections per year, and I'm old, 64. Now that group may not be particularly discerning, I will admit. But the actual Dysport data is in their FDA label, the package insert, and it is blown away by the comparable DAXI data.
Belgium -- this article discusses why their rate is so high (highest in the world, I believe).
https://www.npr.org/sections/coronavirus-live-updates/2020/04/22/841005901/why-belgiums-death-rate-is-so-high-it-counts-lots-of-suspected-covid-19-cases
At least in part, it's because they count suspected cases as due to the virus, all nursing home deaths are treated as due to COVID-19:
Here's the study design section and number of subjects parts of the protocol, for those who don't want to download it:
4.1. Study design
This is a randomized, open-label, parallel-arm study to investigate the efficacy and safety of pamrevlumab in patients with documented SARS-CoV-2 infection. The study consists of screening, a treatment period, and a follow-up period.
The study will enroll patients who have been hospitalized and who are not currently on invasive mechanical ventilation. The treatment period is open ended, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a pre-generated randomization list. Pamrevlumab dosing, 30 mg/kg IV, will be administered at day 1, day 7 and day 14. Day 1 is defined as the day of randomization which must also include administration of the first dose of pamrevlumab for patients in the active treatment arm.
Based on Investigator’s decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks.
Since the treatment scheme of pamrevlumab for this study is more intense as compared to previous studies conducted in IPF patients, as a further safety measure the first 3 patients randomized to receive the experimental drug will be treated one at a time, leaving a 1-week observation period between them.
A follow-up by visit or phone call will be performed 8 and 12 weeks after the end of the last dose of treatment. The treatment period for an individual patient will not exceed 11 weeks. The end of the study is defined as last patient last follow-up visit/phone call.
The study design has a total sample size of approximately 68 patients and consists of two stages. At the end of Stage 1 (Stage 1 requires 23 patients on pamrevlumab treatment arm), analyses of efficacy and safety will take place with a potential to stop the study for futility or for efficacy. A data
review committee composed of experts in respiratory medicine and intensive care will be involved in study oversight and interpretation of the study results. In patients showing worsening of clinical condition, independently of the treatment arm, the Investigator is free to introduce any therapy considered necessary.
4.2. Number of subjects
The study will enroll approximately 68 patients. The study will first enroll approximately 50 patients in Stage 1 and may continue to enroll more patients after review of Stage 1 data.
This link takes you to a zip file of documents for the trial
https://www.aifa.gov.it/documents/20142/1131319/FibroCov_documenti.zip/1e050949-513c-4199-ee6e-5779516da4e3
The 11 page protocol is in English. The other two, Italian.
Depends where you are. In the part of Westchester I am in, in theory there is delivery from supermarkets but in practice I can never get a slot, other than from Amazon/Whole Foods. However, there is curbside delivery from some, which is what we do. And there are specialty stores that ship $20 free range chickens and so on. So between all of those things, we don't have to go into stores. But not everyone is as lucky as I am.
<<Does flu vaccine help stave off COVID-19?>>
Not what the Cell article says. It suggests that exposure to the common cold may provide some immunity, the summary states:
<< I'd suggest you use two cups and a fify foot string.>>
My wife and I have a combined age of 134 but no other known Covid-19 risk factors. We have barely seen another human for 2 months other than the UPS and Fedex guys but our 24 year old daughter is going to visit to pick up some of her stuff for a new apartment (she lives and works in Maine). We intend to eat dinner with her outside, with her at one end of a 10-foot table and my wife and I at the other end, and I propose to put three fans blowing air across the table at various heights.
<<Results showed that 95% of participants (90% female) were highly satisfied with the twice-yearly treatment schedule >>
This is a fairly subjective standard. If you look at the results as summarized on their label on page 22 of this https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125274s107lbl.pdf,
presented in close to the same format as the results of the Sakura trials on page 18 of this https://investors.revance.com/static-files/44313e27-b5bf-46d1-a33d-7b06902860e3
you will see that DAXI blows Galderma away. E.g., the none or mild response rate at 120 days is 23% for Galderma and about 64% (interpolating from week 16) for Daxi. At 150 days, it's 9% for Galderma and about 45% for Daxi.
<<False positives would further inflate the putative prevalence rate relative to the true prevalence rate>>
Of course. It seems that NY has not disclosed the accuracy for its test. One article I saw said:
<<probably a population with higher seroprevalence than the population as a whole>>
Perhaps, but at least sonewhat offset by false positives and presumably people who are or recently were symptomatic are more likely to stay home.
This is perfectly consistent with the test from two weeks ago, which showed 20% infection rate for NYC, as reported in NYTimes and elsewhere. https://www.nytimes.com/2020/04/23/nyregion/coronavirus-antibodies-test-ny.html
Moreover, how does this trash every model out there? This suggests an IFR of about 1%, higher than many other IFR estimates. (population 8 million x 20% = 1.6 milliion infected, roughly 1% of that number of have died in NYC).
If the IFR were 1% and 70% of the US population is ultimately infected, that's 2 million deaths.
As someone who uses IB, I take some minor comfort from the fact they are making customers whole for the software glitch (failure to display negative prices). The only commodity I've traded in recent years were a few bitcoin contracts.
The CDC model Hptaxis linked to at https://int.nyt.com/data/documenthelper/6926-mayhhsbriefing/af7319f4a55fd0ce5dc9/optimized/full.pdf
shows about 3000 death a date on June 1. The IHME model you linked to shows 890 deaths per day on June 1, optimistically reducing to 88 per day by August 1.
But I agree with your bigger point. Seems to me it's mostly random noise, none of the modelers really have any idea. We were supposed to have a peak, with a symmetric decline because their models assume a normal distribution. Instead we are in a plateau. Someone needs to tell the virus to conform to a normal distribution.
jbog, you linked to the IHME model, the NY Times reported and linked to a new CDC model. The IHME model doesn't even show new cases.
The article argues:
And yet GILD is up over 4% and the market in general is flying, Preciouslife1 quoted Jim Cramer displaying a sophisticated understanding of the results:
to continue this chain, I SHOULD be interested in muni's since my muni portfolio is larger than my biotech portfolio, but I never found it very interesting -- which is, of course, a investment error. We all have our flaws and that's the least of mine. Watching the huge bid asks on one of the muni ETFs i hold (MYN) during the worst of it was not boring but thanks to the Fed, things have quieted down. In any event, I'm certainly interested in seeing posts on the subject. I do read them and will dig deeper at some point.
How does this scale up? It’s true that for a fraction of what has been spent compensating for unemployment, we could provide everyone with a nice set of gold P100 masks - if only they existed. But there aren’t enough N95s for healthcare workers, let alone 100’s of millions for the proletariat.