Think about this in its simple nature:MSB have several MSC...

Think about this in its simple nature:

MSB have several MSC therapies in development all based around the same biotechnology, with 3 or 4 very close to approval - some are blockbuster revenue makers (HF & LBP)

The primary elements that MSB need to prove out to the FDA on all their MSC therapies across the board are:

- Efficacy

- Mechanism of Action

- Safety

- Potency Assays

This has been a hard road for the first approval as MSB has had to prove all these elements out in fine detail and more, all while the FDA learning as well.

If MSB receive an approval just for aGVHD and proven these four major elements out, what does that actually do for the entire company and it’s all of its MSC therapies ?

Well from a simplistic view MSB would have just proven out 3 of the 4 elements for all their other therapies.

MSB will have received approval on their MS cell’s for
- Mechanism of Action
- Safety
- Potency Assays

In a simplistic view then MSB only need to primarily prove out final Efficacy for their other therapies, and of which they have already primarily proven in various Phase 3 trials already with potentially just one more short Phase 3/4 trial for confirmation or they will receive an Accelerated Approval for certain therapies because FDA know and have approved so much of their MSC development through the aGVHD process.

Thats why the first aGVHD approval is worth so much as it is basically saying the FDA are approving 75% of all other MSB MSC therapies!

So what is MSB really worth after aGVHD approval?

Yes potentially much more than $7 - $10 in the longer term once the aGVHD approval is gained and impact sets in for all the financial analysts and clinical analysts out there who need to work out the new value of MSB against their substantially derisked MSC therapy platform.

DYOR and not financial advice.