$RLFTF Interesting Ya-hoo posts..
Geoffrey
My guess is that data for 165 has been unblinded and we are awaiting results in the next few days. The change in the study status to not enrolling is either because they were told to halt study or they chose to halt study. There are two reasons to stop enrolling in study 1. Good results which complicate giving a placebo to someone, and 2. Bad results requiring the termination of study. Termination of study for bad results would have been announced and eap sites would have shut down. This piece of information today to me is all good news. They will use the extra 31 for safety, but there is adequate data from 165 to prove efficacy.
WolfZen
@Geoffrey absolutely, a few nice clues have been mentioned leading to just that general consensus. The change from RLF-100 to Zyesami for one, and the other I recall is that the trail can’t have been futile or unsafe since FDA permitted additional recruitment.
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JS
Breath...
You can find in the Dec 6th PR saying "RLFTF met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil)"
This is an agreed upon number with the FDA. DD_Police and many others here still believe the 165th patient is the target and unless there is clarification otherwise there is no reason to think differently. Unless we see PR from RLFTF stating there was a change in the patient number we should expect to see unblinded results and data review by early Jan. EUA approval can be given at any time, but expect early Jan in my opinion.
RLF-100 has been renamed to ZYESAMI (RLF-100). This looks like it is a commercialization tip.
NeuroRx (BRPA) and RLFTF both have agreements in the profits of Aviptadil. You can find the exact percentages for US, EU and other countries on the Relief Therapeutics page under "NeuroRx Inc. Collaboration".
Nothing has changed other than the waiting period is closing thinner and thinner. Hospitals are already overwhelmed, don't give yourself a heart attack and do your research.
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Sevy
I actually believe the data is already unblinded and being looked at and that is why the trial continuation was stopped. I know everyone hates the FDA but they could be chomping at the bit for this considering the awful amount of death we are seeing and about to see. We do have fast track designation which means we cut lines and are in constant contact with the FDA. Dr. J mentioned he was receiving calls and emails at all hours of the night from the FDA. I am being positive but believe me it is not out of naivety. I hope I am right.
Lisa
LAVIN Consulting. Established by Dr. Philip Lavin. Renowned biostatistician. Responsible for more FDA approvals than any other biostatistician.
“Dr. Lavin is a highly - respected biostatistician with more than 30 years of experience supporting design and analysis of clinical trials. Previously, he was a member of the Biostatistics faculty at Harvard School of Public Health and member of the Department of Surgery at Harvard Medical School, where he was an affiliate for over 25 years. He Co - founded Boston Biostatistics in 1983, company now known as Aptiv Solutions. During his career, Dr. Lavin has served as lead biostatistician for 50 FDA approvals, including 38 PMAs, more to date than any other biostatistician.“
Geoffrey
My guess is that data for 165 has been unblinded and we are awaiting results in the next few days. The change in the study status to not enrolling is either because they were told to halt study or they chose to halt study. There are two reasons to stop enrolling in study 1. Good results which complicate giving a placebo to someone, and 2. Bad results requiring the termination of study. Termination of study for bad results would have been announced and eap sites would have shut down. This piece of information today to me is all good news. They will use the extra 31 for safety, but there is adequate data from 165 to prove efficacy.
WolfZen
@Geoffrey absolutely, a few nice clues have been mentioned leading to just that general consensus. The change from RLF-100 to Zyesami for one, and the other I recall is that the trail can’t have been futile or unsafe since FDA permitted additional recruitment.
----
----
JS
Breath...
You can find in the Dec 6th PR saying "RLFTF met the 165 patient enrollment target agreed with the U.S. Food and Drug Administration (FDA) in the ongoing phase 2b/3 trial of RLF-100™ (aviptadil)"
This is an agreed upon number with the FDA. DD_Police and many others here still believe the 165th patient is the target and unless there is clarification otherwise there is no reason to think differently. Unless we see PR from RLFTF stating there was a change in the patient number we should expect to see unblinded results and data review by early Jan. EUA approval can be given at any time, but expect early Jan in my opinion.
RLF-100 has been renamed to ZYESAMI (RLF-100). This looks like it is a commercialization tip.
NeuroRx (BRPA) and RLFTF both have agreements in the profits of Aviptadil. You can find the exact percentages for US, EU and other countries on the Relief Therapeutics page under "NeuroRx Inc. Collaboration".
Nothing has changed other than the waiting period is closing thinner and thinner. Hospitals are already overwhelmed, don't give yourself a heart attack and do your research.
----
Sevy
I actually believe the data is already unblinded and being looked at and that is why the trial continuation was stopped. I know everyone hates the FDA but they could be chomping at the bit for this considering the awful amount of death we are seeing and about to see. We do have fast track designation which means we cut lines and are in constant contact with the FDA. Dr. J mentioned he was receiving calls and emails at all hours of the night from the FDA. I am being positive but believe me it is not out of naivety. I hope I am right.
Lisa
LAVIN Consulting. Established by Dr. Philip Lavin. Renowned biostatistician. Responsible for more FDA approvals than any other biostatistician.
“Dr. Lavin is a highly - respected biostatistician with more than 30 years of experience supporting design and analysis of clinical trials. Previously, he was a member of the Biostatistics faculty at Harvard School of Public Health and member of the Department of Surgery at Harvard Medical School, where he was an affiliate for over 25 years. He Co - founded Boston Biostatistics in 1983, company now known as Aptiv Solutions. During his career, Dr. Lavin has served as lead biostatistician for 50 FDA approvals, including 38 PMAs, more to date than any other biostatistician.“
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