IMHO, the published guidelines already reflect the direction and thinking of the FDA. These guidelines formalise what the FDA is already using and going to apply going forward. Hence, I do not believe that NWBO plans to withhold release of TLD pending adoption.
In any event, I believe these guidelines will be adopted by the time the FDA makes an approval determination. I further believe that NWBO regards these guidelines as a kind of "insurance" for greater regulatory flexibility in dealing with issues of cross-over/confoundment and immunological approaches. I believe that the trial itself will, overall, be successful and approved on its own merits and that these guidelines are the icing on the cake. I don't think, for one minute, that NWBO believes that without these guidelines it cannot gain approval. Rather the guidelines are helpful but NWBO can deliver undeniable results as Les has explicitly stated. JMHO.
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