Replies to post #664679 on NorthWest Biotherapeutics Inc (NWBO)

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2. Interpretation of Validation:

Validation vs. Assessment: MHRA clearly distinguishes between validation (confirming completeness) and assessment (evaluating scientific merit). Public announcements around validation could inadvertently misinterpret this preliminary step as a signal of imminent approval, potentially misleading stakeholders.
Focus on Public and Investor Protection: MHRA prioritizes safeguarding public trust and preventing potentially detrimental speculation. Early pronouncements about unassessed drugs could fuel unrealistic expectations and undermine the importance of a rigorous evaluation process.
3. Regulatory Precedent:

EU Marketing Authorisation Procedure: Though separate from the UK now, the previous centralized authorization process under the EU Medicines Agency (EMA) discouraged press releases on validation, encouraging communication only after positive scientific opinions were issued. This practice serves as a reference point for UK regulations.