... Post corporate update.I said somewhere in the past that I...

... Post corporate update.

I said somewhere in the past that I thought November would probably be the month MSB would start looking at funding. No idea if this will be through an equity placement, partnership, or some kind of royalty deal.

I note that they STILL HAVE NOT given the FDA the additional IL2RA potency information and they said it would take a few months.

My guess is that it is atleast another 6 months away ( being pessemistic ), which is beyond the cash runway they currently have ...... hence ...... capital raise needed.




I also have another hunch, that they are deliberatly delaying the adult trial, because if they commence the adult trial, and there is a hiccup with the FDA's acceptance of this additional potency assay after it commences, and they want a further change or have some other stalling tactic, like now you can revert to the original one..... if the trial has started it will be costly and take time to change everything over and get the change approved through the FDA.



Thirdly - I really can't tell what the FDA are now asking for, and so I really have no idea if this additional data is going to turn out to be an approval in 4 months time or not. Either we will need to wait for the adult trial results, or the FDA accept whatever it is that MSB are giving them related to IL2 RA.

The thing is..... if FDA reject these " updated " potency assays because they were not exactly the same in the paediatric trial ( And we don't know for sure exactly what or how they changed ) , then there is nothing to stop the FDA claiming this next adult trial therefore will be the first phase 3 using the new potency assay derived product, and then claiming the paediatric results cannot be used in conjuction...... and then requiring another 2nd well controlled trial after the initial adult one.


But back to my original point, I think they are about to get a cash inject from somewhere likely next month.

But god it would be great if they submit the extra potencyu data and FDA approved it in chjildren in a few months!