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Re: doingmybest post# 63295

Monday, 05/30/2016 1:31:13 PM

Monday, May 30, 2016 1:31:13 PM

Post# of 699514
I'm not saying manufacturing is the cause of the hold. I'm saying they need regulators okay to enroll patients to a new patented manufacturing method. But the new method is technically on a clinical hold in Germany. And the new UK site to handle delivery may not be fully cleared by regulators yet. I imagine they are close.

As for me answering his other points in the posts, that was done to substatiate NW Bio's statements in which they stated that one of the biggest reasons cellular products are put on clinical hold during either clinical or product development is due to manufacturing. In their case they need to qualify their new manufacturing process, so it is considered product improvement not an error. I sincerely doubt that Frauhoper ran into any issue. But they are changing the delivery supplier so there is a chance that the service they use to deliver product around Europe. I doubt that is the case, as I believe they would have been legally obligated to disclose to us within 3 days. Since they did not, I'm assuming no issue.
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