HappyLibrarian,
Les covered the bases about the 17 missing SOC/placebo patients too out of necessity for trial integrity and to allow “the process” to continue unabated while also preparing commercial scale manufacturing almost from scratch and keeping heat off of regulators. You know my complaints about “the process” and why the status quo is upheld as I have repeated them over and over. You also know that I support management and realize that much of what management gets blamed for was due to them needing to find a viable path forward financially against the odds, working around “the process” and all of this over a great deal of time for a game changing platform that almost nobody with money originally believed in. There were no big grants to move the process along quickly in the early stages either only NWBO and Linda Powers were able to help carry then pick up the pace of this trial with regard to enrollment even though manufacturing became the major headwind after this. All issues are now nearly resolved.
We criticized Linda for asking for manufacturing help openly at the industry expert theater a few years ago but because that help did not materialize, to the best of our knowledge, we now own the manufacturing process that others will want access to. I’d say we are sitting in the catbird seat just waiting for the fuller story to be told ; ). Best wishes.
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