$RLFTF From PurpFiction on Yahoo MB:
“After digging into the I-SPY trial and scraping it against Dr. Javitt's interview with Yo, I found some nice nuggets to share that may have been overlooked. Walk with me:
As we all know, per the Jan 11th PR, "NeuroRx, Inc. and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"
, and the Quantum Leap Healthcare Collaborative ("Quantum Leap" of San Francisco announce that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of ZYESAMI™ (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial." First of all, this is a pretty exclusive club. "The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense."
From the QLHC PR on Dec 15th, "Candidates will be selected that target the body’s response to the virus, known as host-targeted treatments, for the sickest patients. Other criteria include: the candidate’s development stage; the safety and efficacy data available to-date; available supply of the drug; realistic expectation that emergency use authorization could be granted during the current pandemic; and manufacturing capability that could get promising treatments to patients quickly." That's some nice confirmation that we've checked those logistical boxes to even be considered for inclusion. That "realistic expectation that EUA could be granted during the current pandemic" line is nice to hear too...
The clinical trial has not updated since Sept 2020 on the .gov page, but per Javitt's interview with Dr. Yo last week, Javitt states at time stamp 29:20 that "this drug is being tested in I-SPY in inhaled form for the same patients who are currently on high flow oxygen." "...is being tested" is a great sign as the platform style trial will allow "data reviewed frequently to eliminate ineffective treatments quickly and to move promising treatments quickly into later-stage clinical trials." The fact that Zyesami is still being tested means that at the very least the monitors haven't concluded that the inhaled form is ineffective.
Now, if you continue listening to Javitt, in the same breath he states "and we've just signed a very exciting clinical trial agreement with the NIH." Going back to the QLHC I-SPY PR it states, "Promising results could position those potential treatments for late-stage clinical trials with private sector or inclusion in the ACTIV clinical trials led by the National Institutes of Health." Is it possible these two are related? Seems awfully fast, but the I-SPY trial was built to "rapidly screen multiple potential drugs simultaneously." Bring'em in and push'em out...either back to the drawing board or onto the next level. And even if their clinical trial agreement with the NIH isn't directly related to I-SPY, it sounds like we've reached the top of clinical trial mountain so to speak. Thoughts?”
“After digging into the I-SPY trial and scraping it against Dr. Javitt's interview with Yo, I found some nice nuggets to share that may have been overlooked. Walk with me:
As we all know, per the Jan 11th PR, "NeuroRx, Inc. and RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief"
, and the Quantum Leap Healthcare Collaborative ("Quantum Leap" of San Francisco announce that NeuroRx and QLHC have signed a Clinical Trial Participation Agreement for the inclusion of ZYESAMI™ (RLF-100TM: aviptadil) in the I-SPY COVID-19 Clinical Trial." First of all, this is a pretty exclusive club. "The inclusion of ZYESAMI™ in the I-SPY COVID-19 Trial follows a request from the U.S. Department of Health and Human Services and the Department of Defense." From the QLHC PR on Dec 15th, "Candidates will be selected that target the body’s response to the virus, known as host-targeted treatments, for the sickest patients. Other criteria include: the candidate’s development stage; the safety and efficacy data available to-date; available supply of the drug; realistic expectation that emergency use authorization could be granted during the current pandemic; and manufacturing capability that could get promising treatments to patients quickly." That's some nice confirmation that we've checked those logistical boxes to even be considered for inclusion. That "realistic expectation that EUA could be granted during the current pandemic" line is nice to hear too...
The clinical trial has not updated since Sept 2020 on the .gov page, but per Javitt's interview with Dr. Yo last week, Javitt states at time stamp 29:20 that "this drug is being tested in I-SPY in inhaled form for the same patients who are currently on high flow oxygen." "...is being tested" is a great sign as the platform style trial will allow "data reviewed frequently to eliminate ineffective treatments quickly and to move promising treatments quickly into later-stage clinical trials." The fact that Zyesami is still being tested means that at the very least the monitors haven't concluded that the inhaled form is ineffective.
Now, if you continue listening to Javitt, in the same breath he states "and we've just signed a very exciting clinical trial agreement with the NIH." Going back to the QLHC I-SPY PR it states, "Promising results could position those potential treatments for late-stage clinical trials with private sector or inclusion in the ACTIV clinical trials led by the National Institutes of Health." Is it possible these two are related? Seems awfully fast, but the I-SPY trial was built to "rapidly screen multiple potential drugs simultaneously." Bring'em in and push'em out...either back to the drawing board or onto the next level. And even if their clinical trial agreement with the NIH isn't directly related to I-SPY, it sounds like we've reached the top of clinical trial mountain so to speak. Thoughts?”
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