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                  <text>July 3. 1969
6. Grodberg. Director
Research and Development

Mr. Marcus

Davies Rose Hoyt
633 highland Avenue
Needham. Massachusetts 02194
Dear Mr. Grodberg:

principal phase
study program are:
The

Sidney Merlis

Arthur Sugerman
Donald Gallant
George Simpson

I drug

evaluators of the

HIMH-ECDEU

Central Islip State Hospital, N.Y.
new Jersey Neuropsychiatric Institute
Tulane University
Rockland State Hospital

men are accustomed to evaluating new psychoactive drugs,
but do not usually report studies of sedatives.
There are also a number of fine researchers in Europe who
are now doing phase-I studies. often at a cost less than USS.
investigators. and with U.S. investigators as monitors or co—
analysts. In one study, the data was prepared on NIMH-type
forms and analyzed here. There has been some discussion as to
whether such trials can be included in an FDA submission. This
objection to foreign work is to my mind, not relevant in phase I
studies. where drug toxicity and dosage are the principal questions.

These

If such a European trial interests you. my laboratory may be
able to monitor and process the data. One advantage of a European
trial is the possibility that some EEG data for classification
purposes may be obtained concurrently.

It

was kind

suggestions

may

of you to

be

helpful.

visit

my

laboratory.

I

trust these

Sincerely yours,
Fink. M.D.
Professor of Psychiatry

Max

MF:kp

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              <text>Correspondence to: Grodberg, Marcus G.</text>
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              <text>1969 </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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