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Re: exwannabe post# 403131

Tuesday, 09/21/2021 6:55:42 PM

Tuesday, September 21, 2021 6:55:42 PM

Post# of 720887

Along with the law, regulations and past experience. - exwannabe



Above is your response to my post pointing out that your comments (listed below) were also assertions.

The issue being discussed if the FDA/EMA will care about a publication as you assert.

They will not. As much as you and the rest of the SMA will assert they will. - exwannabe



When you get a chance, could you share with me the law that states the FDA does not care about any publications written pertaining to a drug?

I agree with others here that a journal article on the DCVax-L data can certainly help to more thoroughly inform key opinion leaders on the details of the trial; and I think that can help aid FDA in their justification to approve DCVax-L.
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