learningcurve2020,
No need to rewrite what you posted because it was written to appease regulators and give a boiler plate disclaimer to investors against assuming approval will happen or when. This was purposely written this way so that the process of pursuing exceptions to adequate and well controlled studies could be followed. This would require an SAP with modified endpoints that regulators would first need to sign off on which is why the disclaimer was written in regarding the modification of the trial parameters. The missing 17 patients basically covers any modification of trial parameters just by mention of this one of reduced trial size as an example. That they already were pretty certain from the data why the 17 SOC/placebo patients were kept out and had to keep that under wraps was not necessary to disclose in making this disclaimer. You want simple when this was all nuanced for good reasons including trial integrity as long term data was being collected and the development of closed system commercial scale manufacturing was being pursued since 2014 with an indeterminate readiness date.
This all was happening while the share price was under attack after big pharma data from their own trial demonstrated greatly improved outcomes utilizing DC vaccine with checkpoint inhibitors and NWBO had applied for that combo patent. Whoops, don’t you just hate it when you find out that your own research shows you that your upstart pip squeak competitor has a better product than you do and outsmarted you with claims for the combo?; ). Best wishes.
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