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Re: Dan88 post# 39737

Monday, 08/31/2015 9:05:17 PM

Monday, August 31, 2015 9:05:17 PM

Post# of 701425
In short, if there were ever a safety issue in the current P3 L trial, the FDA would have placed a hold on the trial, and the company would have to stop not only new screening of patients, but also treating any existing patients in the trial.

In the meantime, the sponsor will investigate what is the cause of the safety issue. If the investigation concludes the safety issue has nothing to do with DCVax-L vaccine, the results will submit to FDA. If FDA agrees, the trial may be resumed; on the other hand, if the investigation concludes the safety issue does have something to do with the vaccine, the trial may be over for ever!

I hope I will never need to reply to you for the same reason.

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