2024 Here we go again., page-569

So to Recap.

4C released.

Plan is no change - on track for resubmission by June 30th -> SR GvHD in children approval decision 6 months later ( by Dec 31st )

CLBP trial has commenced ( the final expected phase 3 trial before the first of the blockbusters )

FDA suggested an accelerated approval for LVAD CHF patients, and will meet about what they require in the submission ( No timeline given ).

$117 million in the bank, reduced spending holding strong, advanced paydown of some of the loan facility has occured.

What's Next?



2024
By Mid August - FDA acceptance of BLA re-resubmission and setting of PDUFA date.
$$$ By Dec 31st - Sr GvHD in Pediatrics approval decision

Additional Guesses
July - Dec, FDA Pre BLA meeting for accelerated CHF treatement



2025
CLBP trial completes enrollment & provides DSMB update at some point.


Guesses
By Dec MSB submit accelerated approval for CHF in LVAD
By end June, if GvHD Pediatrics is approved, MSB apply for label extension based on real world evidence in adult EAP program


2026
Bioreactors are turned on
$$$ GvHD adults label extension decision in H1
$$$ CLBP trial completes with topline results the same as previous phase 2 and phase 3 trials.
$$$ Grunenthal milestone payments due CLBP
$$$ MSB announce distruibution partnership with Surge centre? ( Currently on MSB board )
$$$ FDA approval decision on CHF treatment with LVAD.
$$$ MSB announce massive partnership with leading HF pharma channel.

2027
SP north of $20 and climbing,