Denial,
I have also tried to follow that line of thought, do we really need a P3 in this area? Wouldn't P2 data be enough? But the few discussions I've had with some parties in the know suggest we would most like need a P3 in this area. Being an Orphan indication, things can work out quicker but better to not necessarily assume that.
The other thought I had is some sort of FDA voucher:
1) We are an Orphan Disease
2) Our drug does indeed apply to juveniles that are suffering with no other solution in the market (Pain relief for joints affected) in the lysosomal indications.
Again, I'm assuming nothing will eventuate in terms of speed to market here...but who knows.
Always good to get pleasantly surprised.
Denial,I have also tried to follow that line of thought, do we...
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