Who would’ve guessed the COVID-ARDs trial would’ve been halted...

Who would’ve guessed the COVID-ARDs trial would’ve been halted for futility after the third interim analysis. Mesoblast had everything at their feet, all they needed to do was show their product actually worked, as I stated in these posts below.

https://hotcopper.com.au/threads/ann-remestemcel-l-fda-fast-track-designation-for-covid-19-ards.5794097/page-192?post_id=49292044
https://hotcopper.com.au/threads/ann-remestemcel-l-fda-fast-track-designation-for-covid-19-ards.5794097/page-202?post_id=49294235

Unfortunately, it turns out remestemcel-l does not work. Sure, you can say “but it only ‘works’ in some patients, but not others”. But that is not the point. The point is it needs to be proven in a randomised, double-blind clinical trial and remestemcel-l has failed each, and every single time. There are only so many “shots at goal” a treatment gets before it should be set to the side and abandoned. It is time shareholders tell Mesoblast to abandon remestemcel-l or at least to renegotiate terms.

Ok, maybe I’m being a bit harsh. After all, Ruxolitinib failed its COVID ARDs trial and yet it is approved by the FDA to treat multiple indications. Mesoblast and Novartis will also unblind the data in February/March to see if there is any value in continuing the partnership. However, it is fair to say this has now turned into a salvage operation.

What I am most astounded by are all of these “hindsight experts” who have flooded the message board to dissect these results, none of whom provided their views beforehand. I, like many others, believed this trial would succeed based on the 25% mortality rate shown in the EAP, the 60% mortality rate published in the literature and us passing the first two interim analyses. As it was revealed yesterday during the webcast the patient population recruited for the EAP were ~15 years younger than those in the phase 3 trial, partly as a result of improved SOC preventing younger patients from requiring IMV, making it impossible for Mesoblast to meet the primary endpoint. For those who don’t understand the significance of this revelation you may want to see this post:

https://hotcopper.com.au/threads/overwhelming-efficacy-the-stats-required.5579134/page-513?post_id=48381458

The good news is Mesoblast still have their mesenchymal progenitor cells (MPCs). I’ve always felt their MPCs were better than the MSCs, and the results from the DREAM-HF trial were promising. Now we await the results for the CLBP trial, and if they are successful, then maybe I will buy back in.

Finally, a message to all of you “hindsight experts”. The good news is results for MPC-06-ID are about to drop any time now and I started a thread where we can discuss the scientific rationale about whether we can expect this trial to be successful. Any robust views are welcome (for or against). It’s now time to put your anonymous reputation on the line and test your foresight capabilities. As a wise person once told me “we are all experts in hindsight, but it takes a true expert to have foresight”.

Here is the thread:
https://hotcopper.com.au/threads/mpc-06-id-phase-3-results-countdown.5680597/

Commiserations to alland good luck to those still holding.


Disclaimer: These are my views only and you're welcome to yours. Not advice