Hi @col69, yes, I agree entirely. And I'd add, people don't...

Hi @col69,

yes, I agree entirely. And I'd add, people don't usually examine the prospect of successive applications in a proper manner IMO. I see indications being treated as stand-alone. That's not the case, as far as the regulators are concerned. For example, the FDA looks at each indication along with all data attaching to each other indication then being tested as an IND for the same drug product.

If, say, there were to be an initial approval for Rexlemestrocel-l (in any dosage) for HLHS, and regardless of whether it took the form of an Accelerated Approval, as seems likely, that would IMO make it much more likely that additional indications would be approved as supplemental. Especially, if they were the subject of a BLA at around the same time.

That increase in likelihood of further approvals has not, IMO, been factored, or factored properly, into value calculations. However, until an initial approval is imminent, it's difficult to make the point to the market.

Cheers,
Have a good one