@dolcevita,
You said, "Has it ever occurred to you that he (SI) is right? That this is the appropriate way to deal with the threat to life and prove efficacy when the rate of mortality is so high?" You then went on to talk about "novel therapy", etc.
Again it's the crux of the issue. Yes, I invested in the company on the premise that SI is right and that the therapy is novel and beneficial. But I don't believe stem cells deserve special treatment by the FDA no matter how great an expert SI might be, no matter how laterally he thinks or how much help he may have given to the Agency. I believe strongly in "evidence-based medicine", which rests on the foundation of selecting medicines based on data and NOT expert opinion. MSC's must prove themselves in RCT's just like any other therapeutic. One of the criticisms of the FDA (at ODAC as I recall) is that SI has indeed exaggerated the mortality rates in his cherry-picked historical controls, thereby making the performance of rem-L look better in comparison. GvHD is a complex evolving illness affecting patients on a host of immuno-modulators, I posted a partial list. Treatment advances and improvements are always being made making it hard to match up historical controls The only way to avoid this type of selection bias is to enroll patients prospectively and let chance assign them to a control group, not human agency. Anything short of that can lead to mistakes...after all, rem-L doesn't take mortality to 0%.
By the way, I have no issue with SI's salary, and would expect the board to pay his replacement even more. I do have a problem with SI's performance which extends beyond the two CRL's. I previously touched on it in a discussion with Pledge during the Novartis debacle. Mesoblast has been around some 30 years and we're 10 years out from the acquisition of the Prochymal technology.... since inception over $1B has been paid in by private investors and signifiant debt has been loaded on. And the best we can present to the FDA is 13 prospective controls involving children with a disease that occurs predominately in adults. We're all over the map on indications being pursued... GvHD, ARDS, Crohn's/IBD's, CHF, CLBP plus others. Some focus may be in order. No indication has completed the requisite 2 phase 3 RCT's., though they're trying to cobble something with end-stage CHF and less-severe cases, another shortcut. These programs are all bogged down, opaque to investors and not progressing. Most notably, Crohn's dz is stuck in a 15-year RCT "still ongoing" according to the company's website, go click on it now, but most likely blocked from completion due to the contract terms SI signed with Osiris. The second CLBP trial is delayed for unexplained reasons, the ARDS one due to the CQA issue. The Novartis partnership was a disaster and while not entirely the fault of SI he allowed it to drag out too long, communicated poorly with investors, failed to negotiate a breakup fee, and so far has failed to replace them. And then there's the current market cap - a pretty reliable reflector of all of the above.
For someone collecting his salary, I expect better results. Enough on-the-job training, the Company needs an executive with a track record of taking medications across the FDA goal line. No one is irreplaceable.
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