Regenerative Medicine and Cell Therapies Virtual Event, page-35

10:25 “…. we have completed accrual of phase 3 studies in both chronic heart failure and lower back pain, and we are getting ready to perform the second phase 3 study for both of those studies.”

I wonder how this will play out. If we get a good readout on both conditions but still receive a request by FDA for both to proceed to two P3 trials, then that will signal a likely 18 month period before commercialization (as I am guessing we will need to wait for P3 results before being able to submit a BLA and ODAC meeting etc). If this is true, it will be quite frustrating as it places more pressure on the COVID trials to be successful given this is in part a reason why the readouts were delayed by circa 6 months.

It does make it difficult to complain as I fully support MSB's decision to try for the COVID cure for both humanity and commercial reasons, however if the results of the P3 trials are promising, it may be that complaints should be directed to the FDA for making MSB go through another round of P3 trials. Surely if results are good instead of P3 trial they could do confirmatory trials instead of new trials?

In terms of the EU trial for CLBP, will this be a joint FDA/EU trial or two separate P3 trials? Surely having two trials for the same condition would be overkill...