Hello All,We are so fortunate as investors, to have the likes of...

Hello All,
We are so fortunate as investors, to have the likes of OP / Turtle , together with many other posters (to many top mention), share their research with us. Clearly their both very caring individuals , who wish to share their views with us Mesoblasters so that we are in the best position to make our own current & forward decisions.

These days, I dont post as much but read the forum avidly ... going straight to the likes of the above (Boonie / Stocky / Col / DD ect) and avoiding Of the 1000's of trolls over the last 2 moths .. I may have read 2 (by error !).

OP .. like many holders, I share your sentiment re the sequential process being put in place for the OTAT meeting to be 1st up and potential BLA sunmission.

FINALLY, we should ALL be excited on talking about these NEW developments ... as the FDA's comments indicating ... "that the potency assays currently in development appeared to be reasonable based on in vitro results provided in the briefing document, the in vitro activity of the product appears to be relatively well established, though the relationship between in vitro activity and the product’s actual mechanism of action remains theoretical” ..... is definitely NEW information we have not had before.

And with NOVARTIS .. in Rurenga's words .. " Yeah Man ! " .. why wouldn't they be just as excited .. particularly after the approval by FDA of Dexamethasone as standard of care.

Unsure if Holders have considered the game changer (imo) for Novartis here, as Dexa is now SOC for not just Covid Ards .. BUT alsoALL-Cause Ards (the market that Novartis are after). On the back of the HIH 221 patient trial and the 77% improvement in Ventilated patients using combination Ryonsil / Dexa ... I could understand if Novartis would be just as damn thrilled as I am , about what the future holds around developing a treatment for ALL Cause Ards.

As Col69 keeps telling us, where last year ( ~ Nov /Dec 20) everyone thought the vaccines would severely suppress the Covid Ards .. unfortunately this has not been the case. In this regard, I cannot see how Novartis could kick off an ALL- Cause Ards trial without recruiting Covid -Ards patients.
So imo, good chance that Novartis will look to do the anticipated Covid Ards p3 trial (vs NIH).

Looking forward to Next Steps
Be safe and sane !

GLTAH