NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

AllSheWrote,

I think you have MHRA confused with a potentially compromised FDA that allows for more subjective decision making. MHRA would have voiced concerns early on to NWBO if they thought the statistical analysis plan was amiss. Instead they actually published an approval of it while the FDA only “accepted” it as a potentially approvable plan. Linda knew this was how the process worked BEFORE submitting to any regulator. Approval of the SAP by MHRA mitigated the chance of ultimate rejection of the MAA by MHRA based on that. That’s kind of important for a cash strapped company to be able to depend on BEFORE investing any more time and money into final preparations for approval with manufacturing upgrades, new employees and other infrastructure on the way to a final MAA decision. That’s called risk management and Linda is really good at this which is why Cognate and Advent were held separately for so long; ). Best wishes.