Ann: Trading Halt, page-387

Everyone else has an opinion on the halt timing so I might as well add to it.

MSB’s wording is pretty clear. They don’t expect to announce until Monday. If the news was at one of the two extremes, either complete unrestricted approval or complete rejection, I can’t see any justification for that delay.

For that reason, like a few others, I’m thinking it’s most likely conditional approval with something attached.

The level of FDA concern about batch consistency/potency/QA at ODAC, (despite MSB’s outstanding responses), suggests that they might want some form of confirmatory study or additional data monitoring. Normally this would just mean further $m R&D expense and delay for the company, achieving no greater market share if it’s eventually successful. ie. A definite negative.

But in this case, could MSB turn conditional approval to their advantage?

I’ve read that the projected annual return to MSB from approval of Remestemcel-l for pediatric SR-aGVHD is small in comparison to the blockbuster returns of Jakafi (with all its side effects) for adult treatment of the same condition. So I recall this slide from MSB’s August presentation.


That’s a pretty clear statement of intent by MSB to target Jakafi’s market share imo.

So if conditional FDA approval for pediatric SR-aGVHD came with requirements for additional confirmation/monitoring, would that be a major negative?

Definitely not imo if the conditions could be achieved through a parallel trial in adults, potentially opening access to a much larger market.

If MSB are using the next few days finalising a program such as this with the FDA, that's time well spent imo.

Pure speculation. Usual bias.
Herro