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Friday, April 02, 2021 8:47:53 AM
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
andrew.mcconaghie@informa.com
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.
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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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