Growing doubt on COVID-19 Application, page-40

I would suggest anyone, holder or potential holder perhaps even those that hold short positions to have a look at the the last few presentations. This is all the available information we have that points to the only worthy conclusion . Remestemcell-L will gain approval, it is not a case of " if" it is a case of "when ".

The opening post is nothing but a play on investors hopes of a rapid growth in SP . All holders would like to see this growth yesterday however we also know that every thing to do with the FDA is time consuming even in a pandemic. The minutes of the meeting are due at the end of this month. To reach this stage in the current time frame is actually remarkable, I have no doubt that the FDA Novartis and MSB are progressing this indication in a manner they think is appropriate to the current emergency . We are probably 18 months perhaps 2 years ahead of the usual time frame. The trial continues to gather longer term data yet we have already met with the FDA.

Out side Mesoblasts presentations and announcements the current COVID 19 situation only adds more urgency to address those last few remaining issues in manufacturing. I think the FDA regardless of previous sentiment and motivation may well reconsider the strong stance they have had and be far more open to a progress and monitor strategy , same as with the COVID vaccines.

We should also remember that Novartis isn't just paying a entry fee of 50 million, they will be committing several hundred million in costs of running a confirmatory all course ARDS and milestones so isn't it reseable for them to wait and see what the FDA considers the best way forward.

Every day that passes is a day closer,
good luck .