DREAM HF Trial Video, page-30

Reflecting on the conversation that I had with SI at the AGM and what he has recently said in another article - this is IMO...

• Mesoblast focus has been on Ryoncil - whilst this is the smallest indication, it is important to Mesoblast and will transform it from a research based biotech into a commercialised biotech company. Ryoncil is the closest indication to commercialisation
• They didn't want to confuse the market and FDA by focussing too much on other indications, so things were progressing but slowly on other fronts
• Now that the Ryoncil BLA has been submitted, Mesoblast can put some more effort into other indications
• Potential partners were awaiting for Mesoblast (a small Aussie company) to prove that they have the capacity to navigate the FDA approval process
• The CRL was a thorn that can only be resolved via the Ryoncil BLA resubmission
• The wheels are now in motion, and these potential partners can gain confidence as Ryoncil progresses through the FDA approval process e.g.

1. acceptance of paperwork - implies FDA acceptance of no additional RCT is required to confirm efficacy!
2. Indication that the assays are valid - open the door for ARDS trial to be progressed, trial design, partnerships etc
3. Singapore manufacturing site inspection - indicates that we are closer to approval. As why would the FDA bother with this if they have other issues with this BLA?

• Other news: JACC peer review article, Chrons
• Partnerships $$$

Exciting times!!!

GL MSB'ers - onwards and upwards