Silviu 17th June - Stem cell summit notes, page-45

rather simple with the CLBP and CHF meetings… if the FDA agree that the post-study endpoints MSB have disclosed as demonstrating a clinical benefit are applicable endpoints, then they have basically hit the jackpot and all a partner needs to do is to run a confirmatory endpoint based on insanely strong phase 3 data, and have a very good shot at having a product in market after a single trial (for them).

accelerated approval is potentially on the cards, and if it is… then we will know very quickly after these first post study meetings with the FDA

and data rejection is also on the cards, but that would be counter intuitive as stem cells are such a new field, the FDA would effectively be knocking back the entire field if they were to severely penalise MSB for not getting the endpoints right .. with only anecdotal guidance at the time of setting up these trials.

I am personally extremely excited by the results generated by MSB in these phase 3 trials, and the logical next step would be to ask MSB to confirm these results … as they seem too good to be true.