During 2022 MSB are looking to be:
1. Resubmitting Ryoncil BLA with up to a 6 month review
2. Back in the clinic with the second pivotal phase 3 CLBP trial
3. Back in the clinic with the second pivotal phase 3 CHF trial
4. Back in the clinic with the second pivotal phase 3 COVID ARDS trial
Ancilliary outcomes supporting the above could include:
1. CLBP global ex EU/Latin America partnership
2. CHF global ex China partnership
3. COVID ARDS / ARDS partnership
Game changing outcomes could include:
1. Approval of Ryoncil
2. Expedited approval pathway recommended for CHF product / Revascor
Downside risk on the above:
1. Ryoncil BLA resubmission rejected by FDA
2. Another CRL for Ryoncil
3. Clinical trials fail to achieve new FDA agreed primary endpoints
Nothing is without risk, but I like our chances on the upside.
IMO only
Goodluck all
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