But yet there was no identification of the significant bias int he screeners, the dosings, the statistical manipulation -- none addressed in the manuscript they reviewed. But clearly identified in the significant comment attached to the article and the Journal of Neuro-Oncology that published a detailed criticism. Regulators will see it clearly, especially the deficiencies in using post hoc protocol, external comparator selection, OS confounding, among others.
Since NWBO hasn't completed any regulatory applications and filings, DCVax-L will be unlikely to have a decision until 2024. MHRA takes 150 days, FDA will be standardly 12 months. Hope you're patient.
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