No minutes?
These additional clinical data, together with the proposed Phase 3 trial protocol in adults with SRaGVHD have also been provided to FDA.
Reg about to draw a very very long bow.
The data for trial 001 is now sufficient - FOR APPROVAL
The anticipated feedback on the trial protocol is not required to be given - as we do not need the adult trial to prove up 001 potency of product on the shelf. There is no adult protocol feedback.
Company has nothing to update about- they will when/if pediatric gets approved and a new protocol is drawn up for a confirmatory trial in adults- which may be under accelerated approval conditions.
Have I gone mad? Some, including myself , were speculating re an accelerated approval in kids once the Adult trial commenced recruiting.
What if it is now Full Approval in kids with accelerated approval in adults?
My views are to be taken with a grain of Murray River Salt Flakes
Reg
No minutes?These additional clinical data, together with the...
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