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I'll be extremely surprise if they are allow to do this in the...

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AlCp

26,354 Posts.

1711

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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Last 3.1¢		Change 0.001(3.33%)		Mkt cap ! $50.71M

Open	High	Low	Value	Volume
3.0¢	3.1¢	3.0¢	$24.03K	797.8K

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No.	Vol.	Price($)
1	15100	3.0¢

Sellers (Offers)

Price($)	Vol.	No.
3.1¢	76157	1

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No.	Vol.	Price($)
1	15100	0.030
5	3709999	0.029
1	66051	0.028
10	1073008	0.027
5	561630	0.026

Price($)	Vol.	No.
0.031	76157	1
0.032	657754	5
0.033	37136	3
0.034	25000	1
0.035	310888	3

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