Good evening Holders.
Bottom line: today DSMB observed signs of efficacy (no question on safety).
Let’s keep in mind thatthere is no other alternative. Let me restate this again – No otheralternative
IMO – Meso on track.
GLTAH
Anjo
Bell Potter Securities Limited
FRIDAY 4TH SEPTEMBER 2020
Mesoblast(MSB) has announced today that the interim data safety monitoring Board (DSMB)has completed the first interim analysis of 90 patients in the ongoing 300patient Phase 3 COVID-19 ARDS trial with remestemcel-L and recommended that thetrial continue as planned.
The DSMBhas reviewed all safety data and data on the primary endpoint of the trial i.e.all-cause mortality at 30 days from randomization and made theirrecommendation. We note that because it is a blinded trial, unless the trialis stopped early we would not see any data from the trial as otherwise it wouldcompromise the trial.
We alwaysthought it was a high bar for DSMB to stop the trial early for efficacy basedon safety and efficacy outcomes from just 45 patients treated withremestemcel-L, given trial is randomized 1:1 and 45 of the 90 patients would beon placebo.
The factthat they have recommended the trial continue as planned with no changes to thepowering of the trial or the planned second and 3rd interim analysesat 45% and 60% patients recruited in the trial suggests to us that the curvesbetween both the treatment and the control arms are separating and we just needmore patient numbers to increase that differential.
Now thenext interim analysis from the trial is expected when 45% patients have beenrandomized and followed up for 30 days i.e. 135 patients. We believe thecompany should meet this recruitment target in the next week or two as thereare several new sites expected to come on-line in COVID-19 hotspots over thisperiod in addition to the 17 US sites that are already recruiting and therecent ethics committee approval to include Australian sites in the trial inSydney and Melbourne.
Weexpect by end of October we could have the second interim analysis for the DSMB– again during which they will recommend either the trial stops early orcontinues as planned.
Tanushree Jain
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