Yes pmcb did withdraw their application after being asked some basic questions by the EMEA. Why they couldn't answer them is concerning to say the least.
As agreed during the previous meeting, a list of issues was sent to the sponsor for response. The sponsor was asked to clarify the following issues:
• Intention to diagnose, prevent or treat
To establish correctly if there exists a scientific rationale for the development of the proposed product
for treatment of pancreatic cancer, the sponsor was asked to further elaborate on:
- details on the proposed product, in particular the rationale for the proposed formulation;
- details on the clinical studies, in particular patients’ characteristics and treatment protocols.
• Significant benefit
The arguments on significant benefit are based on a potential improved efficacy in the condition.
The sponsor was requested to further discuss the arguments provided for significant benefit and to elaborate on:
- the comparison of the results for the preliminary clinical studies with the current standard of care for a similar population in the context of current European guidelines.
In the written response, and during an oral explanation before the Committee on 9 December 2014, the sponsor discussed in particular two available preliminary clinical studies in patients affected by the condition. The COMP considered in particular that the positioning of the product vis a vis the currently available products was not clear.
In communicating to the sponsor the outcome of the discussion, the sponsor formally withdrew the application for orphan designation, on 11 December 2014, prior to final opinion.
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