Tuesday, August 24, 2021 12:50:29 AM
$NRXP conversation
There were two updates to the NRx aviptadil prepress papers on SSRN - I don't know if anyone took a look at the other 45 person study that was updated/posted. This is an administratively-controlled expansion of the 21-patient study to include 24 SOC comorbid covid patients while providing control of a single ICU and consistent SOC/personnel.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228
It's significantly larger and more detailed - it's the Expanded Access Protocol utilized by patients with significant comorbidities and included 24 covid, comorbid patients as a non-treatment group. 21 patients had Aviptadil +SOC and 24 received SOC in the exact same ICU. Huge results in this thing - 9-fold increase in survivability, 6-point ordinal scale improvement. Lavin even put the data into some serious lockdown to ensure bias wasn't introduced...reject null hypothesis for any P-value greater than 0.001, and study variables was powered to 80% to detect a minimum 45% improvement in all situations so that the FDA guidance regarding non-randomized, administratively controlled trials regarding dramatic effect was adhered to.
I'm thinking this may be part of the additional statistical analysis performed as per the request by the FDA for Real World Data (EAP 240-patient data; Nov 24, 2020 and June 15, 2021 PRs about positive EAP results), as well as further distinctions requested for controlling for site of care. I think this is way bigger than anyone has pointed out as of yet. $NRXP $RLFTF
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