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Post by lennymnkd on Nov 6, 2021 15:50:17 GMT -5
FDA ; probably new Paxlovid was coming/ pfizer
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Post by peppy on Nov 6, 2021 16:18:01 GMT -5
FDA ; probably new Paxlovid was coming/ pfizer Pfizer says its pill aims to defeat the spread of the virus in the body by deploying a new compound that can bind to an enzyme of the virus, blocking it from replicating inside infected cells. The company has touted it as a "potential first-in-class" therapeutic designed specifically to target the virus. Pfizer's drug, named Paxlovid, includes a low dose of ritonavir — a medicine which is also used to treat HIV/AIDS — which Pfizer says helps prolong the drug's effectiveness in the body. Pfizer's drug works in a similar way to remdesivir, an antiviral which was approved by the FDA to treat COVID-19 last year, but the pills would be easier to administer than remdesivir, which must be given as an I.V. in a hospital or clinic. www.cbsnews.com/news/covid-pill-pfizer-merck-availability/ |
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Post by goyocafe on Nov 7, 2021 6:38:41 GMT -5
FDA ; probably new Paxlovid was coming/ pfizer Pfizer says its pill aims to defeat the spread of the virus in the body by deploying a new compound that can bind to an enzyme of the virus, blocking it from replicating inside infected cells. The company has touted it as a "potential first-in-class" therapeutic designed specifically to target the virus. Pfizer's drug, named Paxlovid, includes a low dose of ritonavir — a medicine which is also used to treat HIV/AIDS — which Pfizer says helps prolong the drug's effectiveness in the body. Pfizer's drug works in a similar way to remdesivir, an antiviral which was approved by the FDA to treat COVID-19 last year, but the pills would be easier to administer than remdesivir, which must be given as an I.V. in a hospital or clinic. www.cbsnews.com/news/covid-pill-pfizer-merck-availability/Side effects: (what are the chances the FDA looks the other way?) The upside is this is a short duration regimen and not HIV that never goes away. www.webmd.com/hiv-aids/what-are-protease-inhibitors#2-7Real questions about study design, will it get any attention? www.griproom.com/fun/pfizers-covid-pill-might-not-be-as-great-as-theyre-saying |
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Post by goyocafe on Nov 7, 2021 7:16:39 GMT -5
Kind of seems like docs at CDC/NIH aren’t happy with docs at the FDA in a left hand doesn’t know what the right hand is doing kind of way and are going to push the point (with help from NRXP). I’ll hold my breath. (Get it?) The FDA (I.e. Pfizer, Moderna, etc stocktwits.com/IRNTmakesCRWDitsbitch/message/401255582) have no interest in bringing a small biotech with a winning solution into the fray. With the Merck and Pfizer pills there won’t be a perceived need for Severe Covid treatments in the near future. Those that progress to that stage can continue to rely on the standard of care and cross their fingers. |
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Post by lennymnkd on Nov 7, 2021 8:09:05 GMT -5
Thanks ! The point I was trying to make. … KNEW😀I saw it
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Post by mymann on Nov 7, 2021 12:30:11 GMT -5
Kind of seems like docs at CDC/NIH aren’t happy with docs at the FDA in a left hand doesn’t know what the right hand is doing kind of way and are going to push the point (with help from NRXP). I’ll hold my breath. (Get it?) The FDA (I.e. Pfizer, Moderna, etc stocktwits.com/IRNTmakesCRWDitsbitch/message/401255582) have no interest in bringing a small biotech with a winning solution into the fray. With the Merck and Pfizer pills there won’t be a perceived need for Severe Covid treatments in the near future. Those that progress to that stage can continue to rely on the standard of care and cross their fingers. FDA people should spend couple of hours in ICU and witness the suffering of Covid parents struggling to breathe. Patients drowning in their own secretions. Heartless SOB's. We need drugs that actually make a difference not the crap that doesn't work in critical stage of life. |
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Post by peppy on Nov 7, 2021 12:45:52 GMT -5
Kind of seems like docs at CDC/NIH aren’t happy with docs at the FDA in a left hand doesn’t know what the right hand is doing kind of way and are going to push the point (with help from NRXP). I’ll hold my breath. (Get it?) The FDA (I.e. Pfizer, Moderna, etc stocktwits.com/IRNTmakesCRWDitsbitch/message/401255582) have no interest in bringing a small biotech with a winning solution into the fray. With the Merck and Pfizer pills there won’t be a perceived need for Severe Covid treatments in the near future. Those that progress to that stage can continue to rely on the standard of care and cross their fingers. The Merck pill Molnupiravir and Pfizers new candidate still first week. Trying to stop replication in Nasal and oral tissue? Shane Crotty, "day 21 is in the lung." With the time lines being what they are,   And with all the blah, blah, blah.... the genius put it in terms we can all understand. When the surfactant is gone, the patient dies. When all the lubrication is gone, the ballon/alveoli can not open and close any more. NICU's give premature babies surfactant after they are born, per endotracheal tube.  |
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Post by lakon on Nov 9, 2021 10:35:50 GMT -5
Doctor J, don't take this one lying down. Get your govies at NIH & CDC to throw down with the F-D-A! Time for an ADCOM against these beotches! Get the news out and fight! Why NOT approve the EUA for critical care patients? They are dying, and the FDA complains about data, really? There is not any long-term data about any of the new vaccines, but the vaccines got the nod. Say it ain't so. It's VIP for crying out loud! The FDA should not even have jurisdiction. They have no standing. That's the latest catch phrase for a do-nothing Justice. Why is it that I cannot synthesize a naturally occurring, in the body, peptide, protein, hormone, or other substance and sell it with a purity guarantee? C'mon man! These ass-hats are holding up progress and letting people die. (Oh yeah, I forgot, they know better. What was I thinking?)
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Post by goyocafe on Nov 9, 2021 11:39:15 GMT -5
Doctor J, don't take this one lying down. Get your govies at NIH & CDC to throw down with the F-D-A! Time for an ADCOM against these beotches! Get the news out and fight! Why NOT approve the EUA for critical care patients? They are dying, and the FDA complains about data, really? There is not any long-term data about any of the new vaccines, but the vaccines got the nod. Say it ain't so. It's VIP for crying out loud! The FDA should not even have jurisdiction. They have no standing. That's the latest catch phrase for a do-nothing Justice. Why is it that I cannot synthesize a naturally occurring, in the body, peptide, protein, hormone, or other substance and sell it with a purity guarantee? C'mon man! These ass-hats are holding up progress and letting people die. (Oh yeah, I forgot, they know better. What was I thinking?) Post this hear: finance.yahoo.com/quote/NRXP/community?p=NRXPFrom what I understand, Doctor J reads those posts. Go figure. And while we're on the subject, maybe MC can enlighten us on the formulation effort that has been underway now for several months. I thought this was an easy process (at least to determine feasibility)? |
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Post by prcgorman2 on Nov 9, 2021 22:02:10 GMT -5
Doctor J, don't take this one lying down. Get your govies at NIH & CDC to throw down with the F-D-A! Time for an ADCOM against these beotches! Get the news out and fight! Why NOT approve the EUA for critical care patients? They are dying, and the FDA complains about data, really? There is not any long-term data about any of the new vaccines, but the vaccines got the nod. Say it ain't so. It's VIP for crying out loud! The FDA should not even have jurisdiction. They have no standing. That's the latest catch phrase for a do-nothing Justice. Why is it that I cannot synthesize a naturally occurring, in the body, peptide, protein, hormone, or other substance and sell it with a purity guarantee? C'mon man! These ass-hats are holding up progress and letting people die. (Oh yeah, I forgot, they know better. What was I thinking?) Post this hear: finance.yahoo.com/quote/NRXP/community?p=NRXPFrom what I understand, Doctor J reads those posts. Go figure. And while we're on the subject, maybe MC can enlighten us on the formulation effort that has been underway now for several months. I thought this was an easy process (at least to determine feasibility)? Wow. Easy. Wow. I have a little insight into a technical field (non-BP). I suspect putting freeze-dried compounds on a self-assembling molecule in a reliable way that would be suitable for FDA approval (even EUA approval) is not “easy”. I question whether anyone at Mannkind used that term. |
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Post by goyocafe on Nov 9, 2021 22:20:18 GMT -5
Post this hear: finance.yahoo.com/quote/NRXP/community?p=NRXPFrom what I understand, Doctor J reads those posts. Go figure. And while we're on the subject, maybe MC can enlighten us on the formulation effort that has been underway now for several months. I thought this was an easy process (at least to determine feasibility)? Wow. Easy. Wow. I have a little insight into a technical field (non-BP). I suspect putting freeze-dried compounds on a self-assembling molecule in a reliable way that would be suitable for FDA approval (even EUA approval) is not “easy”. I question whether anyone at Mannkind used that term. Easy to determine feasibility, not necessarily successful. There is a Mannkind patent that also lists VIP in the list of suitable compounds. |
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Post by goyocafe on Nov 11, 2021 8:32:58 GMT -5
I take it nothing was said about this opportunity the past 2 days?
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Post by peppy on Nov 11, 2021 8:38:34 GMT -5
I take it nothing was said about this opportunity the past 2 days? I am repeating this information. From the conference call Nov 10, the notes. Chris-C: NRx progress will depend on stability of product... 40 minutes ago x porkini: formulation is nearing completion with NRXP 41 minutes ago x Also Wyatt posted off topic. Oh, The VIP patent opportunity? |
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Post by goyocafe on Nov 11, 2021 8:42:21 GMT -5
I take it nothing was said about this opportunity the past 2 days? I am repeating this information. From the conference call Nov 10, the notes. Chris-C: NRx progress will depend on stability of product... 40 minutes ago x porkini: formulation is nearing completion with NRXP 41 minutes ago x Also Wyatt posted off topic. This is encouraging. With the new release today of 150 day stability, how does that fit with the “will depend on the stability of the product” requirement. Is that enough in order to formulate? |
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Post by Clement on Nov 11, 2021 8:59:56 GMT -5
It's possible that aviptadil with FDKP can have even better stability than what was announced today. Wait and see.
Human insulin with FDKP has pretty good stability.
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