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                  <text>W

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March 22, l97h
Henk van Riezen, M.D.
N.V. Organon

Oss, Holland
Dear Henk,
am

I look fbrward to visiting with you April 2-h,
writing to bring you up-to~date on a few matters.

and

I

1. Before submitting the supplementary information on
the 01-63 placebo to the FDA, I called the FDA as it has been more
than 2 months since we submitted the original data. They have not
made any determination, so I sent the additional data. I will
have to call them again if we wish a response.

I called Joyce Small about a report. She has sent you
week. She is now finding effects that may be
drug—related and she is testing additional subjects at the 15 mg
dose. I received and sent to her, the additional supplies of OI~63

one

2.

earlier in the

she requested.

'V‘V‘I'E'

In talking to her, I raised the question of EEG effects
of chronic administration of GB-QL, suggesting that we would analyze
her reqords for comparison with our studies of the acute effects. She
was not enthusiastic, pointing out that her tape system was incompatible with mine. Rather than proceed against her initial Objections,
I deferred the discussion until we have had an opportunity to explore
the need and the alternatives.

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studies of

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Abba and Lyle.

has asked for a progress report of our
I asked Joyce for her data; and I have written to

FDA

h. Your review of the Miller report was so thorough that I
could not add much. I was also disappointed in the report and I have
sent it back with some marginal notes supporting your comments.
5. Hastin has sent a new protocol for a study with Sandman
and George. I find it incomplete for filing and I have returned
with a request for the additional information. I will bring a copy

it

with

me.

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vanRiemnOIOOOIOOIOIOOQOMarch22’197k IOODIIOOOOOIOOOOIIpageZ

visited Dorothy Krieger on March 15. She had
received the materials from Organon that day and was most pleased.
She described her program to me, and I found her more interested in
the periodicity of the phenomena and the clinical applications than
in any theoretic or psychologic phenomena. We could not find a
common groun for interaction but left with an agreement that should
we find something of interest we would contact one another.
6. I

and

7. Dr. Strand called me before she left for Europe,
I sent her the high dose (90 mg) OI-63 data from my laboratory.

The rest will wait until my visit. My best
please schedule sunshine for the first week of April

regards——
!

Sincerely yours,

Max

Fink,

N.D.

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