Let's add WayneR or Weener as i call him/her to the list of Ihub Dolts

Post Reply
User avatar
TimGDixon
Posts: 2611
Joined: Fri Jun 26, 2020 4:36 am

Let's add WayneR or Weener as i call him/her to the list of Ihub Dolts

Post by TimGDixon »

LilWeenerWayneR seems to think that the 24 patients were insignificant statistically but Weener is an idiot. This was emergency use for dying people - wtf did he do for them? Not a damn thing - had he or the rest of you read the paper the authors already pointed this out.

"Interpretation: UC-MSC infusions in COVID-19 subjects with ARDS were safe and associated with fewer SAEs, compared to control. Further, exploratory efficacy analyses provide preliminary evidence of reduction in mortality and time to recovery. Notwithstanding sample size limitations of this trial, the observed findings strongly support further investigation in a larger trial designed to estimate and test for efficacy." https://papers.ssrn.com/sol3/papers.cfm ... id=3696875

Let me tell you what this means - there will be a phase 3 and these cells will get approval eventually - TSOI does not have this use under our licensing but i could have it if i wanted it - but the price tag is big and at 9/10ths of a penny we aren't in a position to get it - however all of this inures to our benefit when we finish writing and file our IND - in fact we have already told all of you were are planning two Jadi Cell IND's - the first is CTE/TBI and the second is brain injured, post-ventilated, Covid-19 patients. Both of these will be Phase 2.

So Weener and his little band of weeners can talk all the crap they want but Weener don't own no TSOI stock and neither do any of his little weener club members in fact none of those asswipes own jack squat around here - make them prove it by pulling a cert out of their portfolio.

46 ABSTRACT
47 Background: Acute Respiratory Distress Syndrome (ARDS) in COVID-19 is associated with high mortality.
48 Mesenchymal Stem Cells (MSC) are potent immunomodulatory cells. The aim of this study was to determine
49 safety and explore efficacy of Umbilical Cord (UC)-MSC infusions in COVID-19 ARDS.
50 Methods: A double-blind, phase 1/2a, randomized, controlled trial was performed in subjects with ARDS
51 secondary to COVID-19, at a single institution in Miami, Florida, USA. Randomization and stratification by
52 ARDS severity was used to foster balance among groups. Participants received two intravenous infusions of
53 100x106 UC-MSC, or vehicle, at day 0 and 3. The primary endpoint was safety, defined by occurrence of pre-
54 specified infusion associated adverse events, along with adverse events during 28 day follow-up. All subjects
55 were analyzed under an intention to treat design. Exploratory efficacy endpoints included survival at 28 days and
56 time to recovery (ClinicalTrials.gov NCT04355728).
57 Findings: 24 subjects (12 per group) were recruited between April 25 and July 21 2020. At 28 days post last
58 infusion, patient survival was 91% and 42% in the UC-MSC and Control groups, respectively (p=0.015). No
59 serious adverse events (SAEs) were observed related to UC-MSC infusions. There was no observed difference
60 in number of subjects experiencing infusion-associated adverse events. Treatment unrelated SAEs were
61 reported in 2 and 8 patients in the UC-MSC and Control groups, respectively (p=0.04). UC-MSC treatment was
62 associated with increased SAE-free survival (p=0.008) and decreased time to recovery (p=0.03) compared to
63 controls.
64 Interpretation: UC-MSC infusions in COVID-19 subjects with ARDS were safe and associated with fewer
65 SAEs, compared to control. Further, exploratory efficacy analyses provide preliminary evidence of reduction in
66 mortality and time to recovery. Notwithstanding sample size limitations of this trial, the observed findings
67 strongly support further investigation in a larger trial designed to estimate and test for efficacy.
68 Funding: The Cure Alliance, Barilla, NABTU, DRIF.
Post Reply