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                  <text>m‘w’

mam

..

December 21, 1973
Henk van Riezen, M.D.

Scientific

Develbpment Group

N.V. Organon

Oss, Holland
Dear Henk,

When I received the lettee describing the placebo vehicle,
I read the available regulations. I found none that applied to
IND formulations. Nevertheless, I celled the men at the Division of
Neuropharmacology of the F.D.A., reached Dr. Edward Tocus and
discussed the problem with him. He sent me on to two young associates,
Drs. Kum Kumian and Thomas Hayes. None of the three believed the
question presented a prdblem.

I believe that the formulation is acceptable.
I will

Should you send the supplies to us in the present form,

file

an amendment

to the

IND,

stating that the formulations

used fpr the ongoing studies consist of the type you make available
to me, There will be no objection.

It is probable, however, that should 01—63 come to an RDA,
and you then submit the formulation with a coloring substance, that

the marketing reviewers

may

object.

it

have had severe winter storms here, but
warm sunshine of Palm Springs seems so
wishes for a happy New Year 2
WE

cold today. The
Our

best

is clear
far

Sincerely yours,

Max

Fink,

M.D.

away.

and

�</text>
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              <text>Correspondence to: Simeon, Jovan</text>
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              <text>Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York).</text>
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