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Re: beartrap12 post# 64735

Friday, 06/17/2016 3:10:57 PM

Friday, June 17, 2016 3:10:57 PM

Post# of 699117
beartrap12,

If the MO of a therapy becomes well understood or at least we'll recognized and UCLA's test accurately recognizes responders then open label data can be used to confirm benefit. This then becomes an issue for an ethicist intervention but since Germany has already approved it for use in all GBMs for the HE program , FDA just needs to decide if they agree with Germany's assessment and allow it for compassionate with a confirmation trial along side or perhaps even upgrade their decision to expanded label extension. One way or the other Germany will have the advantage. There will be medical tourism from a delayed label extension from FDA or reimbursement advantage for their own citizens with that already pretty much negotiated except for perhaps final price of DCVax depending on cost/benefit ratio.
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