Of course I don't know! I do know it was in fact knocked back by the FDA, and that decision is currently the subject of an appeal.
I do clearly and unashamedly make an assumption that the appeal will fail, and of course I may be wrong in my assumption!
But that assumption is based on many decades of first-hand dealing with FDA across many products and technologies.
Ann: Half Year Report and Accounts (including Appendix 4D), page-165
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