Back pain trial, page-31

Looking at the company as intrinsically the NPV of a stream of potential future cashflows adequately discounted, I think it calls into question some selection bias when there are in front of us 2 product indications being considered.

These are the back pain trial whose endpoints in function and pain were guided to by the FDA in its previous version and which is now underway as an additional Ph 3 trial being supported by data from the earlier trial, as well as further insights about the potential anti-inflammatory effects of the cells; the second being the set of 2 HF trials for end- and advanced stage patients, which is in the early stages of being looked at for how to gain potential accelerated approval.

The FDA has not said that either of these will be approved, but the heart trials have definitely been used as an example of something that is approvable in this FDA guidance on RMAT products (see p.7):

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious-conditions

The AA pathway for heart therefore seems to be a more near term opportunity than the back pain indication and more significant in a potential cashflow sense. A focus, in isolation, on the former is, to me, an example of a bias towards something that the poster feels he or she commented on previously and has some specific knowledge about. What to me is unclear, is how the specific focus is justifiable, if the next regulatory interaction is likely to be on heart and can potentially shed a fair bit of light on how to work on a BLA, the data needed and how to present them.