Well, we might have been planning to do just that but not have known we had an issue until the CRL. In any case, the subsequent manufacture won't provide the "controlled data" of itself. There would need to be approval, and then new manufacture for testing. And then the study. Whereas CEO Itescu indicated that MSB wanted to jump into the study with existing stock. Also, I think we're talking about $24-30m. of potential inventory, and more importantly the ability to deliver sales & accredit ourself in the US market straight after approval.
Again, I'm not sure we'll be offered accelerated approval, as this "controlled data" issue seems to be being put forward as too fundamental to be dealt with in after-the-fact reviews. Of course, I hope I'm wrong.
Fingers crossed.
Cheers
Well, we might have been planning to do just that but not have...
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