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Posted On: 01/27/2021 11:28:26 PM
Post# of 653
$RLFTF (copy) From poster “LA” on Yahoo board:
“The part that I found the best in the sec filing was this:
The RCT’s Data Monitoring Committee released clinical results of the first 21 patients to OWS for unblinded review. At the request of OWS, these data have been combined with 21 aviptadil-treated patients and 24 concurrent standard of care controls.
A dramatic effect on both survival and recovery from respiratory failure was documented in the combined data set of 31 aviptadil-treated vs 35 control patients (Figure 5). Additionally, a 2.8-point difference in NIAID ordinal scale (P<0.0001) and a 112-point difference in PaO2:FiO2 blood oxygenation index (P<0.0001) difference was demonstrated.
All underlying data and SAS programming code were shared with OWS for detailed examination and verification.
The improvement in recovery from respiratory failure and in survival was preceded in many cases by clear radiographic improvement. In the 21 aviptadil-treated patients from the Houston Methodist study, clear bilateral improvement was noted in 17 patients and unilateral improvement was documented in 2 patients (Figure 5).
A laboratory panel of inflammatory markers, including LDH, troponin, C-reactive protein, ferritin, D-Dimer, and interleukin 6 was obtained prior to and post treatment with aviptadil. In all patients, improvement can be documented on each of the inflammatory markers.
The largest average percent decrease was measured in C-reactive protein (76% ±3%) and interleukin 6 (75% ±3%). No patient demonstrated an increase in any of the inflammatory markers. In contrast, no significant reduction was identified in mean laboratory values for control patients.
This means that 10 of the 21 trial patients that were treated were included with the 21 open label trial and 11 placebo including with the 24 SOC patients and both survival and recovery were documented with multiple clinical and lab endpoints showing p <0.0001.
Just amazing. Also makes me wonder why US didn’t move faster on using this knowing what they knew with 4k people dying a day.”
“The part that I found the best in the sec filing was this:
The RCT’s Data Monitoring Committee released clinical results of the first 21 patients to OWS for unblinded review. At the request of OWS, these data have been combined with 21 aviptadil-treated patients and 24 concurrent standard of care controls.
A dramatic effect on both survival and recovery from respiratory failure was documented in the combined data set of 31 aviptadil-treated vs 35 control patients (Figure 5). Additionally, a 2.8-point difference in NIAID ordinal scale (P<0.0001) and a 112-point difference in PaO2:FiO2 blood oxygenation index (P<0.0001) difference was demonstrated.
All underlying data and SAS programming code were shared with OWS for detailed examination and verification.
The improvement in recovery from respiratory failure and in survival was preceded in many cases by clear radiographic improvement. In the 21 aviptadil-treated patients from the Houston Methodist study, clear bilateral improvement was noted in 17 patients and unilateral improvement was documented in 2 patients (Figure 5).
A laboratory panel of inflammatory markers, including LDH, troponin, C-reactive protein, ferritin, D-Dimer, and interleukin 6 was obtained prior to and post treatment with aviptadil. In all patients, improvement can be documented on each of the inflammatory markers.
The largest average percent decrease was measured in C-reactive protein (76% ±3%) and interleukin 6 (75% ±3%). No patient demonstrated an increase in any of the inflammatory markers. In contrast, no significant reduction was identified in mean laboratory values for control patients.
This means that 10 of the 21 trial patients that were treated were included with the 21 open label trial and 11 placebo including with the 24 SOC patients and both survival and recovery were documented with multiple clinical and lab endpoints showing p <0.0001.
Just amazing. Also makes me wonder why US didn’t move faster on using this knowing what they knew with 4k people dying a day.”
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