Summary
- Mesoblast's Phase 3 trial in Chronic Heart Failure failed to meet its primary endpoint.
It is true that Mesoblast failed to meet the PE in CHF
- We believe Mesoblast's stated positive results in the failed CHF trial used statistical methods and post-hoc analysis that the FDA advises against.
The trial failed to meet it's primary endpoint and as a result of that, the data gained from the secondary endpoints will not be used to gain FDA approval on it's own. So the shorters are correct
There are, however, 2 possibilities for CHF to gain FDA approval. One is to run a new P3 trial with a different PE. Mesoblast cannot possibly afford to pay for this and will require a well-funded partner.
The other option is accelerated approval with a confirmatory P3 trial. Mesoblast may be able to fund the trial via Revascor sales
There's no doubting the secondary endpoints are important, but only in providing strong markers for future trial design
- We believe the COVID-19-related ARDS trial was recommended by the DSMB to be halted for futility.
The DSMB concluded the trial was unlikely to meet it's PE. In other words, it was futile to recruit further patients.
Many posters here are taking the words from the "public relations" people at MSB. Of course, they are going to put the best "spin" on a press release about a major setback.
Not wanting to be too much of a downer, but we all could do with trying to read past the spin.
At this stage, there is no data other than the missed PE. None of us have any clue as to how close MSB came to the 43% reduction in mortality or at what P-value.
- We believe Mesoblast's chronic lower back pain Phase 3 trial will fail.
Going back several months ago, the CLBP trial was the one I had the least confidence in due to the lack of hard measures, such as pathology or Xrays and the fact the trial has been delayed from "mid-year".
Today, that still remains the case but how can we really know for sure? Which is exactly the point - these shorters are just voicing an opinion, just like you or me.
Just because someone with a vested interest wrote an article published in SA doesn't make them right.
- We are short Mesoblast with a price target of $0.
The modus operandi of shorters is to take their position, then utilize all available means to broadcast their negative view to drive the price of the target down.
A few of the points raised were true, the rest are no more than conjecture. They've successfully shaken a few weak shareholders loose, big deal. They are only one positive partnership announcement away from being pulverized
(20min delay)