$RLFTF Zaran DD (opinion) from Ya-00
Answers:
@Ekim the study we are waiting on is for an IV infusion of Aviptadil in critically hospitalized ICU patients... we are waiting for the 60 day results to be announced and an EUA authorization from the FDA.
The second study which supposedly has just begun with the first patient dosed is for an "inhalant" version of Aviptadil for "moderate to severe" hospitalized patients. Same drug taken at two different times in the progression of the disease.
The critically ill may not have enough "lung function" to actually benefit from the inhalant so the IV circulates the drug into the blood stream to enter the lungs through the back door so to speak.
The inhaled version through direct intervention into the lungs is a different treatment and one that is more widely accessible to any and all people, hospitalized or at home. Both methodologies are big things, one may save your life if you're in an ICU, the other could normalize our world through much easier intervention than having an IV needle stuck in your arm........
Also, with the advent of this second study, (assuming it is real and not fake news), Equalizer summed it up nicely, saying that (1.) the drug formulation is obviously complete and available and (2.) it is a very big thing that the FDA is allowing this "direct" intervention into the Lungs. further to this the "investigational regime" for this drug is to be 7 days, 3 times a day inhalation therapy, with good results increased to 14 days.
The overall length of "per" patient monitoring is 28 days with the possibility of monitoring for those released from the hospital early due to the drug's anticipated efficacy. Also, importantly, the size of the cohort is 144 patients, that is half of the 288 patients to be treated in this RCT. The other half of this study is based upon the success of the first half. Assuming success, the second cohort will be "at home" patients who have tested positive for Covid-19.
This is going to be a much faster to completion study than the IV treatment. First the patients aren't nearly as sick (so there are many more to choose from) and the drug intervention is directly to the surface of the Lungs where the disease is also present. Results should be recognizable rapidly and with repeated dosing should ameloriate the symptoms quickly. Nobody wants to be a patient in a hospital, right?
In my opinion, this is the study which could be halted due to the "extreme" effectiveness of the pharmological agent, Aviptadil, in both eradicating the virus itself, and in mitigating any negative effects on patient's lungs. The DSMC could very well draw the conclusion that the trial should be stopped and all patients (placebo included) be given the drug, recommending to the FDA that immediate EUA authorization for the inhaled version of Aviptadil be given.
I wrote an email to Robert Besthof asking for clarification on the two most recent news releases to authenticate that they came from the company or it's proxy.
Further, I wrote Dr. Woodcock, acting head of the FDA a few days ago and she assured me she knew of Aviptadil and believed it was getting started in a US gov't. study soon. I'm not sure if she meant ISPY or Quantum Leap or this inhalant trial as they all are US gov't. studies, right? But, the next day, yesterday, the inhaler news was released, so they are on top of this.
This is as Equalizer said, A VERY BIG, A HUGE DEAL, this (if it works?) is the beginning of seeing light at the end of the tunnel.
The monoclonal antibodies have been shown to have limited therapeutic value and might even cause a replacement of and reduction in one's own NK cells and their associated protection from all other pathogens we need protection from.
Trust in one's body for the answers first, then look around to see what "mother nature" brings to the table, then start manufacturing one's own "stuff," but we don't want the cure to be a mechanism for increased suspectability to other diseases because "we lost" our immunity through our vaccinations.............. do we.............
Aviptadil is a synthetic version of a natural peptide, VIP, 500 million years old. This is an acceptable method of curing this viral disease safely without undue other ramifications.
Just saying... oh! yes, long and strong for Zyesami
Less
..see thread on.....
Answers:
@Ekim the study we are waiting on is for an IV infusion of Aviptadil in critically hospitalized ICU patients... we are waiting for the 60 day results to be announced and an EUA authorization from the FDA.
The second study which supposedly has just begun with the first patient dosed is for an "inhalant" version of Aviptadil for "moderate to severe" hospitalized patients. Same drug taken at two different times in the progression of the disease.
The critically ill may not have enough "lung function" to actually benefit from the inhalant so the IV circulates the drug into the blood stream to enter the lungs through the back door so to speak.
The inhaled version through direct intervention into the lungs is a different treatment and one that is more widely accessible to any and all people, hospitalized or at home. Both methodologies are big things, one may save your life if you're in an ICU, the other could normalize our world through much easier intervention than having an IV needle stuck in your arm........
Also, with the advent of this second study, (assuming it is real and not fake news), Equalizer summed it up nicely, saying that (1.) the drug formulation is obviously complete and available and (2.) it is a very big thing that the FDA is allowing this "direct" intervention into the Lungs. further to this the "investigational regime" for this drug is to be 7 days, 3 times a day inhalation therapy, with good results increased to 14 days.
The overall length of "per" patient monitoring is 28 days with the possibility of monitoring for those released from the hospital early due to the drug's anticipated efficacy. Also, importantly, the size of the cohort is 144 patients, that is half of the 288 patients to be treated in this RCT. The other half of this study is based upon the success of the first half. Assuming success, the second cohort will be "at home" patients who have tested positive for Covid-19.
This is going to be a much faster to completion study than the IV treatment. First the patients aren't nearly as sick (so there are many more to choose from) and the drug intervention is directly to the surface of the Lungs where the disease is also present. Results should be recognizable rapidly and with repeated dosing should ameloriate the symptoms quickly. Nobody wants to be a patient in a hospital, right?
In my opinion, this is the study which could be halted due to the "extreme" effectiveness of the pharmological agent, Aviptadil, in both eradicating the virus itself, and in mitigating any negative effects on patient's lungs. The DSMC could very well draw the conclusion that the trial should be stopped and all patients (placebo included) be given the drug, recommending to the FDA that immediate EUA authorization for the inhaled version of Aviptadil be given.
I wrote an email to Robert Besthof asking for clarification on the two most recent news releases to authenticate that they came from the company or it's proxy.
Further, I wrote Dr. Woodcock, acting head of the FDA a few days ago and she assured me she knew of Aviptadil and believed it was getting started in a US gov't. study soon. I'm not sure if she meant ISPY or Quantum Leap or this inhalant trial as they all are US gov't. studies, right? But, the next day, yesterday, the inhaler news was released, so they are on top of this.
This is as Equalizer said, A VERY BIG, A HUGE DEAL, this (if it works?) is the beginning of seeing light at the end of the tunnel.
The monoclonal antibodies have been shown to have limited therapeutic value and might even cause a replacement of and reduction in one's own NK cells and their associated protection from all other pathogens we need protection from.
Trust in one's body for the answers first, then look around to see what "mother nature" brings to the table, then start manufacturing one's own "stuff," but we don't want the cure to be a mechanism for increased suspectability to other diseases because "we lost" our immunity through our vaccinations.............. do we.............
Aviptadil is a synthetic version of a natural peptide, VIP, 500 million years old. This is an acceptable method of curing this viral disease safely without undue other ramifications.
Just saying... oh! yes, long and strong for Zyesami
Less
..see thread on.....
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