A while since you posted your comment, (19/01/21) but I have been musing over this for a while and I thought I would throw this post out there in the hope that anyone with the necessary expertise could illuminate (if anyone can please do, much appreciated) on the releasing of the trial data.
I (and many others) have commented previously that as it would be "helpful" if the next news was good. While the company as you rightly commented cannot withhold market sensitive information other than for specific reasons (one of which is referenced in the post), perhaps they had found a way to delay it.
I am not commenting on whether the likely outcome is missing primary endpoint but rather why run the risk when if at all possible it would be better if the much bigger "good news" (partnerships in other areas or srGvHD for cashflow) came out before, or a positive announcement on the back partnership was made at the time of the release of the trial data if the endpoint as with Heart was missed?
It seems that the more considered assessment behind the Heart data was "wow", but it was an assessment following an opportunity to study the trial data, and this studying is still going on. You have a list of "questions", such as how did certain cohorts or subsets within the trial fare, and each "question" takes time to answer. At the end of it you have enough evidence to sit down with in this case potential partners and discuss partnership deals whether or not primary endpoints were reached.
This will be happening with Ards. Trial halted recruitment, but then had to run its course. Data will be unblinded and the clever people at Novartis and Mesoblast will go through it and answer these questions before confirming their partnership. That won't happen for a few months while these questions are answered.
So now that Mesoblast have a much better idea as to how the treatments work, they could perhaps have a number of "questions" which would be helpful to know the answer to at the same time did it meet its primary and secondary endpoints for this trial.
Would the the people conducting the trial be able to answer those as well if that is the case? If let's say the answers to certain of these other questions was yes, then our partners could then confirm a European trial which I think would trigger milestone payments and would generally be accepted as share moving up information.
All of this is extremely market sensitive information, @reginaldp posted a helpful guideline as to when market sensitive information may be delayed. I understood from that, that you are able to delay news during a negotiation. Could this negotiation (in this case they have the answers to the additional questions) be a reason for the delay?
There maybe slightly different scenarios to this but hopefully someone who understands how these trials, and reporting systems work and for this post's questions, how and who can analyse the data, before the release of price sensitive information must be made can inform myself and others who maybe curious.
Slightly changing the subject but I believe it is relevant. For those of us who have been fascinated by the Gamestop story, I cannot be the only one who has learnt about "diamond or paper hands". Please let's not bring those terms into the the lexicon to describe Mesoblast shareholder. Even if the CLBP comes out first and misses its primary endpoint I will not be selling, but I am not a "diamond". I do not hold "no matter what", which I understand is the description of a diamond hand. I won't sell because of the data already out there I believe supports my decision to invest to make money over a reasonable timeframe.
If in the future, the data says otherwise then I will sell, not because I am a "paper hand", but because I have no interest in re-enacting a financial "charge of the broke brigade", however glorious!
Regards, Yelrom
MSB Price at posting:
$2.56 Sentiment: Hold Disclosure: Held
(20min delay)