We should conclude from this delay that DCVax-L is the only candidate that aligns with the timing, language, and scope of the MHRA’s statement: “[A] company received major objections and is being referred to the CHM.” The MHRA performance summary indicated that they are not experiencing a backlog—this suggests the application has already been referred to the CHM, meaning the ball is no longer in their court. That makes it a safe and accurate statement for the MHRA to say they are not facing delays on their end. LP’s recent press release stated they couldn’t attend ASCO because they needed to focus on the MAA. Why would they stress the need to focus on this and skip a major conference like ASCO unless they were dealing with a serious issue—such as receiving major objections? And being referred to the CHM is generally not a positive sign, especially given the MHRA’s use of the phrase “major objections.” At this point—over 550 days since submission—it’s highly likely that DCVax-L is the company the MHRA was referring to in that statement.
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