Yah00 took down my post last night. These are all factual numbers. I don't know on what base they removed it. I am reposting it as I notice some people are still arguing the effectiveness.
This was originally a comment to @12345 post. I am posting it as separated thread here and $NRXP to show that Aviptadil works.
The recently published open-label study took place in Houston Methodist under Dr. Youssef. It's made up of two groups: first group (treatment group) included the 21 patients who received Aviptadil under EAP, second group (control group) included 25 patients who were under standard care in the same ICU during the same timeframe as the 21EAP study was taking place. The treatment group had a 81% survival rate at 60days while the control group survived at only 21%. The EAP or open label group was not a problem. The problem of this study lies in the control group whose inclusion was kind of arbitrary (or maybe even hand picked). I complained last year on this board about this control group when they submit it for the first EUA. The conclusion of 9-fold survival advantage between these two groups was not science at all. The FDA came back requiring RCT result. RCT stands for Randomized Controlled Trial. The study can be either blinded or open label but the assignment to treatment arm and placebo (control) arm has to be randomized.
Now back to the 81% survival rate at 60days for the Aviptadil EAP. Is this data valid? Let me show you the survival rate at 60days for the THs:
TH1: 87.5% (A) 100% (P)
TH2: 70.6% (A) 40% (P)
TH3: 83.3% (A) 33.3% (P)
TH4: 84.6% (A) 75% (P) -> this one is Houston Methodist
TH5: 61.3% (A) 18.2% (P)
TH6: 100% (A) 50% (P)
TH Overall: 76% (A) 54% (P)
The RCT Aviptadil arm from Houston Methodist actually had a higher survival rate (84.6%) than the 21EAP (81%) in the same hospital. So my conclusion is the 81% survival rate as shown in 21EAP was not falsified.
The Seeking Alpha 8/11/2020 talked about the DSMB making recommendation based on first 30RCT results. We don't have the full result but we have 21 of them. These 21RCT result was unblinded, combined with the above open-label study/control group and shared with BARDA. Survival curves of the combined dataset were revealed in NRx S1 filing last December. I did a calculation at the time. 12/14 (85.7%) of Aviptadil arm survived 28days, 5/7 (71.4%) of placebo arm survived 28days. DSMB must be pretty optimistic when they saw the first 30RCT data.
So back to @12345's question 'So why were the clinical trial results so different from the prospectus study'. As far as the Aviptadil arm is concerned, you can see from above that the prospectus data is actually very inline with the RCT result in TH. To me there is no doubt Aviptadil works. Our result has clinical significance at the least. Only if we could recruit another 100 or so enrollees!
~ FC, Y@h00 RLFTF finance conversations
FC 49 minutes ago
@12345 you said "also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat."
Now let's look how the SeekingAlpha articles says:
"On July 16, 2020, Relief Therapeutics and NeuroRx announced that the Data Monitoring Committee conducted a planned review of the first 30 patients treated in the Phase II/III Fast Track trial (Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure (COVID-AIV)). Per the release:
The committee determined that the study appeared capable of reaching a statistically significant endpoint within its 144 patient sample size and voted for the study to continue until its next scheduled evaluation in four weeks."
I don't know where you got the idea DSMB based the recommendation on the open-label study - that's certainly NOT what SeekingAlpha was saying.
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12345
123452 5 minutes ago
@FC i’m just reading the seeking alpha article not making any statements
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Lt. Francis
Lt. Francis31 minutes ago
@tito I wonder if the people who survived the ventilator ( and their loved ones ) feel it is Garbage?
Indisputable fact is people that would have died otherwise, lived to tell the story of Aviptadil.
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FC
FC 1 hour ago
@Kpags yeah disappointing to say the least. Hope NDA under the Accelerated Approval pathway will get us there. Any idea what other data is needed for this pathway and timeline?
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Kpags
Kpags 1 hour ago
The TH hospital mortality data comprising 70% of the trial was always what kept me optimistic of approval despite RH disaster. P<.006. Obviously it wasn’t enough for FDA but given the unmet need in this cohort it’s disappointing to say the least.
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FC
FC 2 hours ago
@12345 you got it wrong. DSMB didn't (and prohibited) use the open-label study to make their recommendation. DSMB had nothing to do with the open-label study. They based their recommendation on the first 30RCT result they reviewed. I mentioned that in my post and we knew the survival data on 21 of these 30 patients. At 28days it was 85.7% (A) : 71.4% (P). Just want to get this straight.
Less
Reply
12345
12345 2 hours ago
also in that article the DSMB suggested based on those open label results that 144 is possibly sufficient to achieve stat. They knew it was not random at that time and that the control groups could have been steered to the downside
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FC
FC 2 hours ago
I don't know if the FDA's risk concern has anything to do with the RH data. The RH's survival at 60days:
RH overall: 38% (A) 53% (P)
Aviptadil does look risky this way. But keep in mind RH patient numbers were small and in two of these hospitals all patients died. I don't know what happened in these hospitals. Did they not get enough training on administering the test drug? The Aviptadil arm in RH was only 40% of the one in TH, but they accounted for the same amount of death. Questions for physicians on this board, what might have caused this in your opinion?
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GizmoTime
GizmoTime 2 hours ago
Hence why the FDA needed more data because of the limits to make a confident conclusion of the effectiveness of the drug.
Reply1
FC
FC 2 hours ago
@tito did you not read the post? Houston Methodist had even higher survival rate in their RCT than the EAP study. But for someone who only understand gif, I can't ask for more. ugly low life. Mute
Reply3
tito
tito 2 hours ago
This drug failed. Face the facts. Houston Methodist numbers are not from a real study. They are expanded access patients. That is not intended to be a study. But it is a good pile of garbage from Dr. J. Spinning a story!
