credible critique or not?, page-5

The author makes some valid points, with regard to the use of endpoints which are statistically - but not clinically - significant.  Such criticism could also be made of Mesoblast's other phase 2 trial results, such as the recent diabetic nephropathy results which showed modest improvement in blood markers of kidney function but weren't designed to look at patient-centered outcomes such as what percentage eventually required dialysis.  Although some on these boards take positive phase 2 trial results as a sign that the next blockbuster drug is a foregone conclusion, criticisms such as these serve as a reminder of what a successful phase 3 trial should entail to convince physicians, regulatory bodies and insurers to approve a new treatment.

It should be noted that lack of relevant study endpoints (or even successful studies!) don't automatically preclude a drug from being profitable.  An example is Alteplase, a hugely profitable "clot busting" drug which is widely used to treat acute stroke despite some very conflicting evidence... http://lifeinthefastlane.com/use-thrombolysis-treatment-acute-stroke/

Having said all that, it would be good if Regenexx could apply the same level of intellectual candour to their own "research", which seems to consist of a pitiful mix of case reports and registry data.  They could also be more transparent about their massive conflict of interest when discussing a competitor!