Gary the point Hof is making is that with every new trial started a new trial design (which the SAP (Statistical Analytic Plan) is part of) has to be submitted to the RA which after the data has been collected will be analyzed. After the RA has accepted the trial design (as the MHRA and EMA did with DCVAXL) the approval for the drug after it has met its endpoints as agreed upon with the RA will become much more likely.
Ass Exwannebe claims that no trial design/SAP is needed when starting/conducting a medical trial just that the drug is safe which is absurd and ridiculous.
Exwannebe has zero knowledge of the way biotech trials are being conducted. The MHRA bought into NWBO's most recent trial design when they submitted PIP and thus the MHRA will also accept the way NWBO submitted the data to the MHRA from the DCVAXL trial.
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