I have no insight into the deliberations of the FDA.I would...

I have no insight into the deliberations of the FDA.

I would imagine however that the FDA, like us, would view an approved world-first treatment and possible ‘cure’ for OA as being very much a mass market medication, with the potential, once it gets the FDA’s stamp of approval, for high demand leading to the fast take-up of very large numbers of doses.

As we have seen in the rollout of the Covid vaccines, with any drug there is the potential for unexpected A.Es. (fatal blood clotting, etc. in the case of Covid vaccines), which, because these instances were extremely rare, wouldn’t have been picked up in even the largest of clinical trials, but became apparent when the vaccination numbers reached the millions.

So I suppose that an application for IND in the case of iPPS, which is likely to rapidly develop a high public profile, might lead the FDA to take a more cautious approach to approval than it perhaps would if the drug were aimed at a much smaller addressable market.