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Re: None

Sunday, 06/21/2020 9:47:59 PM

Sunday, June 21, 2020 9:47:59 PM

Post# of 718611
FWIW not being very familiar with requirements for label extension, it would seem reasonable that DCVax L should be applicable and extendable to other tumor types. The manufacturing process and science of action is the same.

Objectively for Direct, while the science of action is analogous the manufacturing process is not exactly the same since the lysate pulsing takes place in the injected tumor and introduces variables around efficiency of the pulsing and size of tumor and needle positioning in the tumor being injected. So while very similar at high level the detail is different enough that additional trial may be required unless a case can carry the day based on the direct prior trial
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