There's no interim antidote for the regulatory valley of death that late stage product developers must pass through. The only remedy is for the regulator to make the decision. I appreciate Glenn's effort but the market is just repulsed by drawn out uncertainty.
I see the outcomes report from the Advisory Committee on Medical Devices' meeting on 13 October has just been released. FMD!! 2 months for a set of skeleton notes to be released!! There really is no excuse for that.
Anyway, other than the regulator shafting us the company seems to be up and active and getting on with things. Well done.
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