Friday, April 08, 2016 12:15:15 PM
How can you be accruing patients while at the same time be listed as active not recruiting unless you are over accruing during a still blinded or quiet trial period? He did not say "waiting to accrue" patients. NWBO said that they would continue to actively pursue new trial sites in anticipation of commercialization. For this to happen in Germany patients must be enrolled at the hospitals to receive final approval. My understanding of HE is that once a patient does not qualify for the Phase 3 ie no longer screening, they can apply as an HE patient. These patients have their data treated like they are in an open label trial with their data used supplementaly for the approval process. NWBO can treat them on a compassionate use basis out of pocket and wait for reimbursement when that is finalized or a patient can pay for the treatment out of pocket.
There is some speculation that an equivalency analysis or other regulatory decision has been holding up some of the compassionate use patients from entering the process. Dr. Prins may be indicating that this is no longer the case at every treatment site by the choice of his wording or perhaps, as your say, they are still waiting for more patients to enter the blinded trial, perhaps in relationship to approval for subgroup analysis as several have mentioned and the NWBO disclaimer would possibly be aligned with.
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