This is good news.
I wonder 2 things:
1. How long is thos review (of their own procedures) expected to take
And
2. With CVAC already having Orphan designation status, wouldn't they already have such an advantage or is the review highlighted more focussed on expediting approvals rather than identifying drug canadicates to be given ODS.
If I understand this well, CVAC having ODS already means it has already got the competitive edge and the review here might bring about a final FDA approval sooner than it might otherwise get it. In other words it is the difference between getting an approval upon successful completion of trials compared to getting approvals prior to trial completion.
This is good news.I wonder 2 things:1. How long is thos review...
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