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Re: To infinity and beyond! post# 328480

Friday, 10/16/2020 8:42:31 PM

Friday, October 16, 2020 8:42:31 PM

Post# of 403091
"How could the FDA to go forward with such an unusual drug with not ready for prime time info?"

I don't think they could, but if I'm not mistaken the Company files the application and the RBL (and PHRI, if they're still around) publish the pre-prints. Their facts should obviously match, but they are different documents.
MOST of the data for the app would presumably come from the RBL and PHRI, perhaps some from each.

My only point was that the pre-prints don't necessarily have to be PUBLISHED before the IND app is submitted and I don't THINK they need to accompany the app, but that question is where this little chat started.

The logical extension of that, if true, is that the IND COULD be submitted before we see the pre-print(s) published.

Whew...talk about a long and winding road :o)

“I have had a wonderful time but this wasn't it.”
..........Groucho

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