Just one other thought I’m putting down so I don’t forget later. I think it’s not beyond the realm of possibility that we’d already have an maa decision on L had Survaxm not passed the futility test (a very very low bar) around Jan/Feb, 2025. (analyzed in January announced Feb 12, 2025). The bar however, upon reflection, appeared so incredibly low that there was almost zero chance of this, imo, so on April 3, 2025, back on the MAA review ledger of matters, guidance changed to allow 3 RFIs and 365 + 9 days total clock off from validation to decision (aka: in NWBO’s case would mean October 11 if they received 3 RFIs.), so here we are creeping up on August 18 at midnight for Survaxm primary endpoint required reporting date in their arguably related trial. (The DCVax-L SmPC draft still awaits to see if a major indication parameter needs to be narrowed or not). We then creep up on October 11, 2025 for maximum time (if no true delay) for MHRA if NWBO was given 3 RFIs, possibly allow a few extra days from decision to announcement. We then approach early November 4, 2025, when the (apparently) data on the last patient randomized in the L trial reaches ten complete years. Note: From validation: 365 days clock off + 9 days clock off guidance required transition + 210 clock on + 24 days clock on late*….assuming 3 RFIs.
(* The 24 days late (or more) actually carries over from the beginning of the maa review following validation, when MHRA were backlogged)
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