Romans 12:19
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..just the beginning.. growing pains.. wondering what this will look like in a week or two..? ..it may be good?
..everyday we get closer to access improving IMO .. here's the write up on your question:
Compassionate use is a treatment option that allows the use of a medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory therapies and who cannot enter clinical trials. ..same as NWBO at this time..
$RLFTF $NRXP “Aviptadil has been granted compassionate care authorization in the United States and Israel and has been granted Emergency Use Authorization in Georgia, Ukraine, and the Caucasus region, as well as India.” INDIA Flag of India GEORGIA Flag of Georgia UKRAINE Flag of Ukraine EUA approved
Updated preprint:
https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
$RLFTF $NRXP “Aviptadil has been granted compassionate care authorization in the United States and Israel and has been granted Emergency Use Authorization in Georgia, Ukraine, and the Caucasus region, as well as India.” INDIA Flag of India GEORGIA Flag of Georgia UKRAINE Flag of Ukraine EUA approved
Updated preprint:
https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
$RLFTF $NRXP “Aviptadil has been granted compassionate care authorization in the United States and Israel and has been granted Emergency Use Authorization in Georgia, Ukraine, and the Caucasus region, as well as India.” INDIA Flag of India GEORGIA Flag of Georgia UKRAINE Flag of Ukraine EUA approved
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Updated preprint:
https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
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Jonathan Javitt from Yh0
Since there seems to be some confusion about what the preprint says, I'm going to restate the science.
ALL PATIENTS IN THE STUDY ARE INCLUDED in all top-level analyses of the primary endpoint. If you see n=196 that refers to all patients treated. Analysis of endpoints within subgroups only follows reports of endpoints for all patients, according to scientific best practice.
That said, the original study protocol as approved by FDA specified that primary endpoints would be analyzed in a regression model that includes covariates that control for differences between the drug-treated and the placebo group at baseline. In this study, the randomization program implemented by the third party CRO assigned more severe patients to the drug group than to the placebo group (see table 3 baseline characteristics .
Remember, when you randomize patients, the computer is "flipping coins" and you should not expect that patients will always be matched in baseline characteristics. The regression analyses used were pre-agreed with FDA at the outset of the study and the manner in which covariates are used also follows published FDA guidance.
The study initially planned to use NIAID score as a measure of baseline severity and the statistical analysis plan was modified prior to unblinding to use type of ventilation as a measure of baseline severity instead because it was a more objective measure.
Readers are clearly free to interpret data as they choose. However, it’s important to understand the data in the first place. All patients, all hospitals, in the primary analysis means exactly that. Nobody was excluded.
This comment will also be posted to our website
$RLFTF $NRXP “Aviptadil has been granted compassionate care authorization in the United States and Israel and has been granted Emergency Use Authorization in Georgia, Ukraine, and the Caucasus region, as well as India.” INDIA Flag of India GEORGIA Flag of Georgia UKRAINE Flag of Ukraine EUA approved
---------
Updated preprint:
https://privpapers.ssrn.com/sol3/papers.cfm?abstract_id=3830051
--------------
Jonathan Javitt from Yh0
Since there seems to be some confusion about what the preprint says, I'm going to restate the science.
ALL PATIENTS IN THE STUDY ARE INCLUDED in all top-level analyses of the primary endpoint. If you see n=196 that refers to all patients treated. Analysis of endpoints within subgroups only follows reports of endpoints for all patients, according to scientific best practice.
That said, the original study protocol as approved by FDA specified that primary endpoints would be analyzed in a regression model that includes covariates that control for differences between the drug-treated and the placebo group at baseline. In this study, the randomization program implemented by the third party CRO assigned more severe patients to the drug group than to the placebo group (see table 3 baseline characteristics .
Remember, when you randomize patients, the computer is "flipping coins" and you should not expect that patients will always be matched in baseline characteristics. The regression analyses used were pre-agreed with FDA at the outset of the study and the manner in which covariates are used also follows published FDA guidance.
The study initially planned to use NIAID score as a measure of baseline severity and the statistical analysis plan was modified prior to unblinding to use type of ventilation as a measure of baseline severity instead because it was a more objective measure.
Readers are clearly free to interpret data as they choose. However, it’s important to understand the data in the first place. All patients, all hospitals, in the primary analysis means exactly that. Nobody was excluded.
This comment will also be posted to our website
$RLFTF $NRXP Zyesami (Aviptadil) COVID-19 Therapeutic Authored by Staff Updated August 5, 2021 https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
$RLFTF $NRXP Zyesami (Aviptadil) COVID-19 Therapeutic Authored by Staff Updated August 5, 2021 https://www.precisionvaccinations.com/vaccines/zyesami-aviptadil-covid-19-therapeutic
The Technosphere is a good tool added to our partnerships.. IMO
$NSAV DD by Ajay Singh
@TheAmbassador_
Peter Chun, founder of Silverbear Capital speaks on Yahoo Finance from the floor of the New York Stock Exchange $NSAV
If you ever have any doubts in Silverbear capital please just wait & see what this team is capable of.
Peter Chun, founder of Silverbear Capital speaks on Yahoo Finance from the floor of the New York Stock Exchange $NSAV
— Ajay Singh (@TheAmbassador_) August 3, 2021
If you ever have any doubts in Silverbear capital please just wait & see what this team is capable of. https://t.co/kyqhSXsUVU
$NSAV DD (opinion) by Wolf of tsx on Yh0 (copy) - Does everyone understand that
1. We are pink slip certified
2. We are the only regulated crypto exchange
3. Binance isn’t regulated, we will take over the Chinese market as they will allow nsav and their won’t be a “crackdown”
4. We are more then a crypto broker we are growing in blockchain a market that will be used for everything from cash to cars to houses in the next 5 years
5. Our management is on board of BITMART
6. The stock patterns are saying this is going to the Milky Way
7. When all these shorters come out and make you panic sell, they line their pockets at .10 cent buys back up to .15-.20
They have been playing this game since .006
This is a healthy build up, we need a little pull back consolidation then explosion ??
Good luck longs and new holders, 22.50 price target we ain’t even close to it yet
..are you insane ? I support this stock and was being clear that I was talking about very few listen to him and not talking about the longs.. look don't reply to my posts anymore.. ok
..to be clear.. not many listen.. ;)
.. small audience..
..they just keep on making the right moves.. that and the established big-time construction companies that I believe mentor this company adds confidence IMO ..this guys connected to a wealth of solutions.
..they wrote 'em .. hahahahaha
...
DD by Equalizer on Yh0 - Nature article: “The Delta variant, which is now spreading around the world, hosts multiple mutations in the S1 subunit, including three in the RBD that seem to improve the RBD’s ability to bind to ACE2 and evade the immune system7.
In SARS-CoV, less than 10% of spike proteins are primed, says Menachery, whose lab group has been quantifying the primed spike proteins but is yet to publish this work. In SARS-CoV-2, that percentage rises to 50%. In the Alpha variant, it’s more than 50%. In the highly transmissible Delta variant, the group has found, greater than 75% of spikes are primed to infect a human cell.
Early in the pandemic, researchers confirmed that the RBDs of SARS-CoV-2 spike proteins attach to a familiar protein called the ACE2 receptor, which adorns the outside of most human throat and lung cells. This receptor is also the docking point for SARS-CoV, the virus that causes severe acute respiratory syndrome (SARS). But compared with SARS-CoV, SARS-CoV-2 binds to ACE2 an estimated 2–4 times more strongly.
The Delta variant, which is now spreading around the world, hosts multiple mutations in the S1 subunit, including three in the RBD that seem to improve the RBD’s ability to bind to ACE2 and evade the immune system7.
Restricted entry
Once the viral spikes bind to ACE2, other proteins on the host cell’s surface initiate a process that leads to the merging of viral and cell membranes.”
When Aviptadil binds to ACE2, the spot and point of entry the virus used to enter the cell is blocked.
Full article in Nature.
https://www.nature.com/articles/d41586-021-02039-y
$NRXP $RLFTF (opinion) by WONG on Yh0 -
Sounds like Dr. J is getting ticked off at this point too. Look at the PR. He says we responded saying you have a two fold advantage of surviving with our treatment and we are sharing this new analysis with other health agencies globally. Sound like he is saying we are done playing your game and we will get approval from countries that actually need and want the help.
In our regulatory response, we presented a statistical analysis showing a statistically significant two-fold increase in odds of survival at 60 days post treatment among those treated with aviptadil, compared to those treated with placebo. The analysis considers all patients at all sites of care and controls for baseline severity of illness using the baseline severity criteria that were prespecified in our protocol. We are similarly sharing these results with partners and regulators around the globe at the request of Health Ministries as the Delta and subsequent variants continue to escalate the COVID public health emergency.
$NRXP $RLFTF (opinion) by WONG on Yh0 -
Sounds like Dr. J is getting ticked off at this point too. Look at the PR. He says we responded saying you have a two fold advantage of surviving with our treatment and we are sharing this new analysis with other health agencies globally. Sound like he is saying we are done playing your game and we will get approval from countries that actually need and want the help.
In our regulatory response, we presented a statistical analysis showing a statistically significant two-fold increase in odds of survival at 60 days post treatment among those treated with aviptadil, compared to those treated with placebo. The analysis considers all patients at all sites of care and controls for baseline severity of illness using the baseline severity criteria that were prespecified in our protocol. We are similarly sharing these results with partners and regulators around the globe at the request of Health Ministries as the Delta and subsequent variants continue to escalate the COVID public health emergency.
$RLFTF The APR acquisition is transforming Relief into a fully integrated and diversified biopharmaceutical business.
On June 29, 2021, Relief announced that it had signed and closed the definitive agreement to acquire all outstanding shares of APR Applied Pharma Research S.A., a privately held Swiss biopharmaceutical company with over 25 years’ experience in identifying, developing and commercializing known molecules engineered with drug delivery systems in niche and rare diseases on a global basis.
The acquisition further diversifies Relief's pipeline with both commercial products and clinical-stage programs and provides the initial commercial infrastructure to support future product launches. APR brings to Relief a vibrant R&D organization possessing a lengthy track record of expertise in drug innovation, reformulation and optimization. APR also has a well-respected contract research business, further reflecting the strong R&D capabilities of the APR team and providing Relief additional revenue growth potential.
https://www.relieftherapeutics.com/apr
..if the S/P is rockin don't come knockin...
$RLFTF DD by SLIMJIM on Yh0 - FROM ADVITA SITE: Patients with post or long COVID-19 syndrome suffer from symptoms such as breathing difficulties, fever, fatigue, cough and decreased performance, although the virus is no longer detectable.
As a result, they can no longer do a regular job and need medical help.
Since these symptoms could be treated promisingly with inhaled aviptadil in individual patients with acute, viral COVID-19 disease, a first clinical study with inhaled aviptadil is intended to confirm relief also in patients with long COVID-19 symptoms.
A letter of intent to conduct such a pilot study has already been signed with a Long COVID-19 center in Austria, and other clinics have agreed to participate in this clinical study. 7/26
..for sure.. 'n foundational, "The real good days are gonna come when the revenue and profit from the next houses roll in"
..price is holding up.. how high will this step up into August..??
..building some serious cars.. and people will pay.. maybe they'll pick up the pace w/more builds (TV show) ?? ...be good to have a reality show to build the brand.. ;)
Absolutely !!
Be blessed.
...hit the ask.
$NRXP $RLFTF DD by Bert-Jan on Yh0 - The WSJ is huge Good PR and business news..
https://www.wsj.com/articles/nrx-pharmaceuticals-announces-first-successful-commercial-formulation-for-zyesami-tm-aviptadil-enabling-volume-manufacture-shipping-and-stockpiling-of-covid-19-medication-subject-to-regulatory-approval-01626950910
..adding new longs daily.. ..we'll lock it up .
I don't agree... Happy to hold both.
..somebody put some Hot sauce on this.. +7
$RLFTF $NRXP DD by LA on Yh0 - Full video of Dr.J speaking at the The Disease Prevention & Control Summit America 2021 on the Small Molecules & Repurposed Drugs For Covid 19 panel this afternoon
$RLFTF $NRXP DD by LA on Yh0 - Full video of Dr.J speaking at the The Disease Prevention & Control Summit America 2021 on the Small Molecules & Repurposed Drugs For Covid 19 panel this afternoon
..maybe they loaded up over the past few months as the s/p dropped and they're willing to sign off on it now.. ??
$NRXP $RLFTF Can Zyesami Treatment Reduce Mortality Rates for Delta? https://lastfuturist.com/can-zyesami-treatment-reduce-mortality-rates-for-delta/
$NRXP $RLFTF Can Zyesami Treatment Reduce Mortality Rates for Delta? https://lastfuturist.com/can-zyesami-treatment-reduce-mortality-rates-for-delta/
$NRXP $RLFTF (talk) on Yh0 Kevin: I sure hope Dr J speaking tomorrow was planned a while back and not a "Hail Mary" w/FDA
Not a doubt in my mind EUA should be granted. Just worry about the timing. Hopefully whatever great news Dr. J delivers will put added pressure on FDA to get this done. Beyond ridiculous at this point.
GS3k: There's a moratorium on any kind of publicity while the EUA is still being decided, if anything this means he has the administration's blessing to speak.