@bedger - I just watched both MSB's recent CHF and Covid-19 ARDS presentations. As far as getting the proper trial candidates into Covid-19 in a timely manner, I think the key reason was alluded to by SI, which is that the MSB trial is being handled as part of an overall Covid trial being managed and run by a US agency where trial participants are being selected and handed off to the various covid trials by the agency rather than the normal process of local selection by participating medical facilities/groups.
I was concerned about this process when I first heard about it shortly after MSB's covid-ARDS trial was approved to begin since it is very easy to manipulate the outcomes of trials in the selection process of patients. If MSB's trial was able to run independently as a normal process the participating patients would have been into and through the trial by July or August and most likely the trial results would have shown overwhelming efficacy. So I do believe the extension of the enrollment period and the evolution of patients being treated becoming worst case in terms of older patients refractory to multiple other experimental therapies certainly determined the failure in the end result. Just imagine the case where remestemcel-l was first line therapy rather than final chance therapy. Remestemcel-l would probably be standard-of-care by now.
My view is that the analysis of data from Covid trial will in fact show benefits in certain "sweet spots", and those will also apply to the much larger non-covid ARDS market, from which commercial opportunities will become apparent in both covid and non-covid ARDS markets.
With regard to CHF it seems rather clear from SI's comments that the mortality reduction, while not a primary endpoint, would be the FDA's primary consideration for approval (after safety which is not an issue here). FDA in my opinion has a very high probability of approving MSB's therapy based on existing data from the trial. A partner is actively being sought in the next few months among large US firms with the ability to make the therapy available on a large scale in short timeframe, preferably with a co-development and co-marketing agreement with Mesoblast.
For anyone who has not listened to the corporate presentations on Dec 15th and Dec 18th I would highly recommend doing so as opposed to just reading the comments of discouraged investors or even short sellers here on HC. Of course, I am discouraged by the recent events, but at the same time see good things in the near term that will make these appear as bumps in the road.
(20min delay)