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No rule was broken!; ). Apologetics are not needed when there is nothing to defend. Stating that a rule or rules were broken is a false narrative that many uninformed investors will fall for because they do not understand the pathway for “exceptions to adequate and well controlled trials” in FDA guidance which ALLOWS FOR CHANGES like this to occur when that guidance is followed correctly and it was because, as you note, THESE CHANGES have been validated by the PIP trial setup.
Waiting out “the process” for FINAL FORMAL VALIDATION of the SAP upon APPROVAL OF DCVax-L, having previously met the necessary REQUIREMENTS OF COMMERCIAL MANUFACTURING for expected demand, is absolutely necessary and has been very poorly understood or accepted by the retail investment community until recently.
I pointed out long ago that I remembered guidance but could not find it, stating that manufacturing would need to be IN PLACE in Europe for approval. Now we all understand finally that the MIA must be approved before the MAA can be granted which is why I have stated since early last year that progress could be monitored by manufacturing news and we are now at the point where we can monitor for MAA acceptance news because of the manufacturing news. Best wishes.
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