G’evening Holders.
Great news today – for Australiaand I’m sure huge relief for Physicians & Hospitals.
IMO only – I think today’sannouncement speaks very positively about the ongoing US 300 patient trial.
I understand that thetrail is randomized , double blinded, placebo controlled trial but Ethics committee do not easily approve ‘experimentaltreatments’ in very ill patients.
Outside of the initialPilot trial, I just wonder what other ‘research’ Monash Ethics Committee mayhave undertaken before approval.
As noted by Vinny , with A/ProfTony Goldschlager being the Principal Investigator for CLBP Aus trials , the adage“actions speak louder than words” should be noted by all in today’s announcement.
Here is BP’s latest note.
GLTAH
Bell Potter Securities Limited
Tuesday 2/9/2020 -
BELL POTTER FLASH NOTE:Australians with COVID-19 ARDS now haveopportunity to participate in MSB's ongoing trial and get access toremestemcel-L
Mesoblast (MSB) has announced today that it has received ethics approvalto include Australian sites to its ongoing Phase 3 COVID-19 ARDS trial withremestemcel-L.
Some hospitals in Melbourne and Sydney will join the 17 US hospitalswhich are currently recruiting patients in the trial.
As per the trial protocol, eligible ventilator dependent ICU patientswith moderate-severe COVID-19 ARDS will be enrolled in the randomizedcontrolled trial and receive either remestemcel-L or placebo on top of maximalcare.
We believe 3-6 hospitals across Melbourne and Sydney are likely toparticipate, with Melbourne likely having a greater presence. We are encouragedthat Australians will now have access to this therapy which could potentiallysave lives.
We expect the current target of getting up to 30 US hospitalsparticipating in the trial is also unchanged.
First interim analysis on 90 patients is also on track to be completedby the independent data monitoring committee in early September. We expect toget their recommendation to either continue trial as planned or stop it earlyfor efficacy in a week or two.
Tanushree Jain
Analyst, Healthcare & Biotech
(20min delay)