I agree
Here is my 2c on the 4C...
Previously, Mesoblast had to do a plan with a few alternatives for GVHD - just in case the FDA Type C meeting was not successful.
All this centred around conducting the adult trial:
- Progress with the adult trial to give it a pathway for the Pediatric AA approval, if the meeting with the FDA was not successful
- Start the adult trial to provide progress with GVHD, in case the FDA raises issues with the CRL
- ...
After the FDA Type C meeting, and confirmed in the 4C report - the adult GVHD trial can be parked, as these alternative plans are deemed as unnecessary now. Hence, "Mesoblast will now focus on its original strategy to first gain pediatric approval for RYONCIL, followedby label extension in the larger adult population."
Again, I think Mesoblast twice bitten by the CRL, got to be very shy of the FDA.
Hence, what assurances has the FDA given to Mesoblast for this change of focus back to its "original strategy"?
I'm not too sure, but it would have been more than a nudge and a wink!
In terms of the label extension for the larger adult population, it's a wait and see for me.
But, all this can only come after Ryoncil is approved for Pediatric.
Exciting times
GL MSB'ers - onwards & upwards
I agreeHere is my 2c on the 4C...Previously, Mesoblast had to do...
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