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PainChek General Discussion, page-10597

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21/01/20

11:23

Post #: 42489283
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Originally posted by GCInvestor ↑

Acceptance of Foreign Clinical Data

FDA Accepts Foreign Clinical data from studies not conducted under an IND if the following conditions are met:

I. Study was conducted in accordance with Good Clinical Practice (GCP)
II. FDA is able to validate the data from the study through an onsite inspection

“Today we recognize that to successfully protect U.S. public health, we must think, act, and engage globally. Our interests must be broader than simply those within our own borders.” Margaret Hamburg, FDA Commissioner

https://www.fda.gov/media/91849/download

Also, PD said in one of the interviews that there were a few simple questions that were asked that they are addressing

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I'll be extremely surprise if they are allow to do this in the end, but I've been wrong before.

PCK Price at posting: 18.5¢ Sentiment: None Disclosure: Not Held
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