U bet an investigation is on ! I remember the first time this happened earlier this year and np
Was so angry the next few days !

Infamous illegal tweets of Tim Sucks i mean Sykes!

What if fiction 1? What if fiction 2? LOL

More Vaccine Side Effects News Today


https://apple.news/A-NkDzTMzTMe7lhm0yOAvIA

Connection to the UK study?

I looked thru twitter to find how the UK study link published on cydy’s website relates to us.
I find univeristy of edinburgh tweeting that they studied or think 9 drugs could be useful to target various genes that cause severe patients to die..one of them is targeted by MABs.


First link is some historical context about the study i guess also says about cytokine storm and genes:

https://pubmed.ncbi.nlm.nih.gov/32909000/

Original tweet(scroll down to comments where one person has posted a screen shot of a ‘mandelian ramndomization’
Where it shows a MAB targetting a gene:

Potential treatments for Covid-19 have been identified after the discovery of five genes associated with the most severe form of the disease. Existing drugs that target these genes opens the path to new clinical trials: https://t.co/8xOTluZ6ZY pic.twitter.com/pVW0rI4yZY

— The University of Edinburgh (@EdinburghUni) December 11, 2020

Ok cheers pic.twitter.com/90vdMGRCx9

— The Laird of Cammo (@stevenreynolds) December 13, 2020

LL on the map . Np fiesty. 5-10 billiin Hoho Merry Christmas!

Yea i realized it late
On a different topic, a great CC. Just heard the recording. I liked how fiesty Np
Sounded today be like “ dude my baby LL is on the map now” kind of fiesty !
I read a lot about cms and fda parral review and stuff so
Would be highly surprised if fda has not already noted something about LL coming to them...i expect hope
Fda would make the EUA announcement before Christmas just going by the prior cms icd10 code added vs fda approval announcement time lines!

Explains fda-cms parallel review program with examples..also why CMS approval means game!


“CMS will not publicly disclose a sponsor being part of parallel review until the sponsor makes it public," said a CMS spokesperson. "The FDA statute doesn’t allow FDA to publicly disclose who is asking for FDA-approval. CMS does not want to get ahead of that process."

There are a lot of trials we are reviewing through the IDE program," Syrek Jensen told Medtech Insight following her presentation. "They're coming in and going through the FDA and they're asking us about the trials. There are a lot of informal conversations that we're having. So it's not officially part of the parallel review program, but there are a lot of communication going on that I think is positive.

Part of the reason Syrek Jensen says people don't hear about some of this work is companies work with FDA on trial requirements and the trials themselves for a long time. After that, manufacturers come to CMS for an NCD.”

https://pharmaintelligence.informa.com/resources/product-content/despite-only-two-parallel-review-success-stories-cms-touts-better-coordination

Happend today at the cms-fda summit

“For instance, in recent weeks we have issued an EUA for the first COVID-19 diagnostic test for self-testing at home that provides rapid results, and EUA’s authorizing the use of monoclonal antibodies for COVID-19 treatment, which is designed to block the virus’ attachment and entry into human cells.”


https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-hahn-fda-cms-summit-12072020

Interesting 2016 CMS reimb vs FDA approved drug study...Merry Christmas!

https://oig.hhs.gov/oei/reports/oei-03-17-00120.asp

Do the mgmt receive a notification about the ICD10 codes?
I tweeted cytodyn but someone who has np’s ears know if they know??

Oh i did the back test too last night on the Aug 3 icd10 code addition for plasma and the subsequent approval announcement 2 weeks later!
Merry christmas!

This already seems to imply the four drugs have approval since the next section is a placeholder for the three are for drugs with approvals “in the coming months”!

https://www.3mhisinsideangle.com/blog-post/more-covid-19-diagnosis-and-procedure-codes-icd-10-cm-pcs-and-ms-drgs-updated-for-january-1-2021/

Monoclonal Antibody (10 codes)


Four specific substances classified as monoclonal antibodies– Bamlanivimab, Etesevimab, Leronlimab and REGN-COV2—have new PCS codes to track their use in treating COVID-19. Leronlimab is administered by subcutaneous injection, and the other three substances are administered via IV infusion.
XW013K6 Introduction of Leronlimab Monoclonal Antibody into Subcutaneous Tissue, Percutaneous Approach, New Technology Group 6
XW043E6 Introduction of Etesevimab Monoclonal Antibody into Central Vein, Percutaneous Approach, New Technology Group 6
XW033E6 Introduction of Etesevimab Monoclonal Antibody into Peripheral Vein, Percutaneous Approach, New Technology Group 6
XW033F6 Introduction of Bamlanivimab Monoclonal Antibody into Peripheral Vein, Percutaneous Approach, New Technology Group 6
XW043F6 Introduction of Bamlanivimab Monoclonal Antibody into Central Vein, Percutaneous Approach, New Technology Group 6
XW033G6 Introduction of REGN-COV2 Monoclonal Antibody into Peripheral Vein, Percutaneous Approach, New Technology Group 6
XW043G6 Introduction of REGN-COV2 Monoclonal Antibody into Central Vein, Percutaneous Approach, New Technology Group 6
Three non-specific monoclonal antibody codes were added to allow tracking of other monoclonal antibody drugs approved for treatment of COVID-19 in the coming months.
XW033H6 Introduction of Other New Technology Monoclonal Antibody into Peripheral Vein, Percutaneous Approach, New Technology Group 6
XW043H6 Introduction of Other New Technology Monoclonal Antibody into Central Vein, Percutaneous Approach, New Technology Group 6
XW013H6 Introduction of Other New Technology Monoclonal Antibody into Subcutaneous Tissue, Percutaneous Approach, New Technology Group 6

Icd10 code for Rem and plasma were assigned on August 1.
Plasma was approved by FDA 20 days later!!
Its a MERRY CHRISTMAS BABY!

https://www.aapc.com/blog/51503-12-new-codes-to-identify-therapeutics/

https://www.marketwatch.com/press-release/new-pharma-trials-making-big-gains-in-fight-against-triple-negative-breast-cancer-tnbc-2020-12-02-91833010

Building up for big PRs...for a while now we have seen one PR at least every week. Most of them did not make a huge impact on sp but were ok. The next three could be bla uk , canada and 75% dsmc assesment/completed enrollment leading to new years. Fingers crossed.

Global covid cases still recovering around 22 million. Expect another 22 mill by the time vaccine reaches u and me. Best Case that is. We need to sell 4 million by next year? Deal will be made on the day of eua or full approval, if not before. Ateast WHO will buy it for 10% lesser than price of the next best mab.


Updated Nov 26 at 2:44 PM local
Confirmed
60,719,579
+617,692
Deaths
1,427,184
+11,072
Recovered
38,904,777
+451,954
See breakdownSee less

Exposure to viral load is not considered?
We know that based on the viral load or duration a person is exposed to
Covid also is a factor to become covid positive or not.
Since the numbers are so small, it is always possible that the people in the vaccine arm were actually exposed to less viral
Load than the ones in the placebo
Arm. And hence fewer could be pcr positive.
This is where a bigger sample of positive people helps.
Perhaps like a thousand. 100 people is too
Small a pop to
Say a vaccine works for the purpose it was designed for. And expecting millions to be vaccines based on this is dangerous!

Visit Wellcome.org and therapeuticsaccelerator.org

These are WHO initiatives for Covid treatments. Tells you the collosal scale of the investment needed
And made by people to get treatments to the world over.
Anyone who thinks our LL will not be used when approved or is late to
The game is ignorant.
It will be like a alibaba.com once in a year sale of the year day when LL is ready for the world.
Sadly we only have like a million doses.

From cnnphilipines.com

I found the site yesterday and its been interesting reading.
So far, good news is that they follow WHO to the tee. So, they are part of what they call a solidarity trial for Covid treatment and vaccine. And they know NO drug (incl ReMdesvir) works as of Oct 26.

See the last line in this article.

‘Last week, a WHO study reported that Remdesivir and Interferon, including repurposed drugs Hydroxychloroquine and the anti-HIV combination of Lopinavir and Ritonavir, had "little or no effect on mortality" for patients hospitalized with the coronavirus. It added that the drugs do not seem to help patients recover any faster either.

Vergeire added that doses of the cancer drug Acalabrutinib, which has been included in the WHO's treatment arm trial, have arrived in the Philippines. Monoclonal antibody treatment will also be included.’

I wonder if the Mab is ours! That would explain the Chiral pharma connection few months back.
May be LL was part of this solidarity trial. I also read another article where a Philipino senator was asking
Why a treatment needed to be tested by philipino fda again after the world or US has approved it.
Tells me may be they already have been using LL in trials like this link says about other treatments!

So, i am thinking Philiines definitively buys a bulk of LL in December!


http://www.cnnphilippines.com/news/2020/10/26/WHO-Solidarity-Trial-vaccine-COVID-19-treatment.html

Cydy will get approval for LL for severe patients. That is the game. Not m2m
that regeneron got for the 2 drugs for. For those wondering why their drug, see the number of trial participants. More than double our total covid patients m2m plus s2c. THANKFULLY LL has efficacy so its just a matter of numbers of participants now. Btw expecting PR any time that 293 enrollment is done for s2c.

Vaccine not enough to stop raging pandemic-WHO

https://www.ndtv.com/world-news/vaccine-will-not-be-enough-to-stop-coronavirus-pandemic-who-chief-2325891

Considering that practically Fauci gave a “media” eua to the pfizer vaccine based on a whooping 93 patients, we should get a looksie at the 230 or so patients that would have reached 42 days by month end

“Yes vaccines will eradicate covid in months”- this boards’ arm chair ceos
“No vaccines will
Never eradicate covid. It will become like flu an endemic”.- Fauci

I trust our arm chair ceos for sure lol

CD12 -based on US setting record after record on the daily cases gosh we will complete enrollment this week

Dr. Anthony Fauci said Thursday that vaccines will ensure we won’t have a pandemic for much longer, but he doubts the coronavirus will be eradicated.

"I doubt we're gonna eradicate this, I think we need to plan that this is something we may need to maintain control over chronically. It may be something that becomes endemic that we have to just be careful about," the director of the US National Institute for Allergy and Infectious Diseases said during a panel appearance in London.
"Certainly it's not going to be pandemic for a lot longer because I believe the vaccines are going to turn that around," Fauci added during the Chatham House event.

Russia says its coronavirus vaccine is 92% effective, in battle to beat the West

Wow! This based on a full 20 patients!

In a Vaccine “battle” (battle for people? $ dude) would you rather not stay safe and get treated if you get Covid or
Get vaccinated especially if any of these get approved based on 93 and 20 patients.

Pfizer CEO OFFLOADS 62% SHARES AFTER TRIAL ANNOUNCEMENT!

Very trustworthy ? LOL

IF this was np, our arm chair ceos would have demolished him!
Please stand in line in April
For the vaccine.

https://m.economictimes.com/markets/stocks/news/pfizer-incs-ceo-offloaded-62-of-his-stock-holdings-post-covid-19-vaccine-trial-success-announcement/articleshow/79175987.cms

https://m.economictimes.com/

Pfizer vaccine- Rich Vaccine?

https://m.economictimes.com/news/international/world-news/deep-freeze-hurdle-makes-pfizers-vaccine-one-for-the-rich/articleshow/79172564.cms

No vaccine is ever “welcome”
as close to a cure. America says.
Covid will be an endemic. LL
Will become like Tamiflu.
Remember this cryogenic stored vaccine is only for the rich countries.
Most of the world is hoping for a shot to cure.

https://bgr.com/2020/09/05/coronavirus-vaccine-update-poll-resistance/

https://www.cnn.com/2019/09/26/health/who-gets-flu-shot/index.html

Arm chair ceos squeezed. Come to our side live peacefully make millions in years rather than making cents daily!

Eli lilly stumble already. Should fda not have looked at this BEFORE EUA (daah)
I hope the 88,000 dozes are recalled.

https://www.bloomberg.com/news/articles/2020-11-10/fda-puts-conditions-on-lilly-covid-therapy-after-issues-at-plant

Market is always risk averse and panics early

A vaccine news had the market sell off zoom , beyond meat etc.
Like the vaccine magically will make people stop eating plant based foods and abandonment of zoom lol
Imagine if a VC invesment went up
And down like this! No one would invest!
Market is made up of many unique investors but one thing is common they do not represent the company or the product.
Setting sp aside of something fundamentally has changed with the safety and efficacy of LL then i would panic
Again, this is essentially a start up in the bp world.

LL- Only product out there for Mortality
This is a great time to get approval
Transition in politics. Trump wants to leave a positive mark.
Do not be surprised if this gets eua before January!

May be LL for Covid was always an outside the US play.
May be we were always planning for UK and Philipines to get it first knowing US BP lobby.

Canada Pre BLA hiv meeting was today per the slide of Oct 14..PR tonight may be
UK BLA filing PR awaited

I see several more hospitals enrolling for the SC on the list in the website . Updated on 11/6.

Slow and Steady wins the race!
Remember the hare and tortoise story!

OK . no other bp drug left? now LL can be looked at?
no one said its an easy game !
Onwards and upwards!

Hundreds of thousands will die and millions more will get sick By the time a vaccine becomes available.
A vaccine wont save anyone getting sick and/or dieing in the next year..sorry to be blunt
Best case scenario a vaccine may help save many lives and help many not become sick starting 2022 onwards
Even then ...read by Tamiflu post . Peace out stay patient