A TH was necessary as it required clarification regarding the certificate being an interim one (albiet expected and has no effect on the progress, if anything helping production to accelerate). The certification on public domaim was not clear on this. Had it not been available on public domain and only sent to the company then the company would be in a position to consider preparing and dispatching announcement without TH.
Ann: Initial GMP Certification for European Production Facility, page-40
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