Replies to post #37846 on Relief Therapeutics Holding AG (RLFTF)

[clambottler]

JAVITT'S BIG SPIN = PART 2

Participants: 196 patients
Enrollment at a 2:1 ratio
meant 131 Aviptadil patients were enrolled
and 65 Placebo patients were enrolled


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Those enrolled were at different stages
OR were treated differently depending on Where enrolled
127 patients treated with High Flow Nasal Cannula (HFNC: n=127)
32 patients treated with Non-Invasive Ventilation (NIV: n=32)
36 patients treated with Mechanical Ventilation (MV: n=36).

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Setting: Ten US-based acute care hospitals,
4 tertiary care teaching hospitals
6 regional hospitals.

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Results: Overall,
91 of 131 Aviptadil-treated participants survived to day 28
compared to 47 of 65 placebo-treated patients
(70.6% vs 71.7%; P=NS).


NO DIFFERENCE between Placebo and Drug Aviptadil/Zyesami
After 28 days


91 of the Aviptadil patients were alive ( 70.6% )
47 of the 65 Placebo patients were alive ( 71.7%)
( yes a GREATER percent of placebo patients were alive
but there is no difference, because and exactly why small numbers
are meaningless )


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The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.

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So what is LEFT ?
HFNC AT TERTIARY CARE HOSPITALS


NOW NOW the Most RECENT PR
GENEVA, SWITZERLAND / ACCESSWIRE / March 30, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF)(OTCQB:RLFTF) ("Relief")
states:


The prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals.
" at tertiary care hospitals. "

NOTICE HE TOOK OUT THE HFNC PATIENTS TREATED AT THE 6 REGIONAL HOSPITALS

Setting: Ten US-based acute care hospitals,
4 tertiary care teaching hospitals
6 regional hospitals.


84% of HFNC patients treated at tertiary medical centers with RLF-100(TM) survived to day 60 compared with 60% of those treated with placebo (P = .007).

""" treated at tertiary medical centers """"

AGAIN HFNC PATIENTS TREATED AT THE 6 REGIONAL HOSPITALS APPEAR TO BE REMOVED

++++ NOTICE --- HE DOES NOT TELL YOU HOW MANY PATIENTS WERE ON HFNC AT THE 4 TERTIARY CARE HOSPITALS

NOR TELL YOU HOW MANY PATIENTS ON HFNC WERE TREATED AT THE 6 REGIONAL HOSPITALS
========================================
========================================


NOW NOW the Most RECENT PR
GENEVA, SWITZERLAND / ACCESSWIRE / March 30, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF)(OTCQB:RLFTF) ("Relief")
states:


"""" According to NeuroRx, across all patients and sites, RLF-100(TM) met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site """""


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In My Opinion that is data mining and quite unfortunate.


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[clambottler]

JAVITT'S BIG SPIN - Part 4

You can see now that the media is catching on


NeuroRx Says COVID-19 Drug Improves Survival If Overstretched ICUs Excluded
Will Seek EUA Shortly


01 Apr 2021
NEWS


Andrew McConaghie
[e-mail]

Executive Summary

Therapy shows some promise in helping COVID-19 respiratory failure patients but the US FDA may question company’s data cut.




https://scrip.pharmaintelligence.informa.com/SC144107/NeuroRx-Says-COVID-19-Drug-Improves-Survival-If-Overstretched-ICUs-Excluded


============================================
Therapy shows some promise in helping COVID-19 respiratory failure patients but the US FDA may question company’s data cut.

====================================

Reminder:
Javitt SSRN QUOTEs:

" Setting: Ten US-based acute care hospitals, which included 4 tertiary care teaching hospitals and 6 regional hospitals. "


" Participants: 196 patients with PCR+ Critical COVID-19
treated with High Flow Nasal Cannula (HFNC: n=127)
Non-Invasive Ventilation (NIV: n=32)
or Mechanical Ventilation (MV: n=36). "

===============================================

Participants: 196 patients

REMOVED 32 patients treated with Non-Invasive Ventilation (NIV: n=32)

REMOVED 36 patients treated with Mechanical Ventilation (MV: n=36).

127 patients treated with High Flow Nasal Cannula (HFNC: n=127)

REMOVED ALL patients treated at " 6 regional hospitals "

Data / analysis = claim of significance provided on patients treated at
" 4 tertiary care teaching hospitals "

NUMBER of patients treated at " 4 tertiary care teaching hospitals "
NOT PROVIDED


==============> many of these hospitals have an inherent bias when treating patients on drug, they just cannot help themselves, it is human nature, nothing mischievious / intentional <==============


My Bet Opinion Hunch Surmise Guess - Javitt knows this Javitt knows this all too well

There is no chance of EUA or maybe a 2% chance
and there is 100 % chance that NO APPROVAL on this trial - its impossible.


Unfortunately the trial for ' approval ' purposes is a disaster -

We do not know how much of a disaster because:

JAVITT removed the 6 REGIONAL HOSPITAL data - so we do not know how many patients he removed and have no idea how those patients fared

and We do NOT KNOW how many patients were treated at the " 4 tertiary care teaching hospitals " -
how many received aviptadil/zyesami
though presume they were enrolled 2:1 per protocol.


In Short - a do over - will have to wait another 6 months perhaps more for the I Spy or other trial results.


Good Luck to All
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