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                  <text>\\

11‘

July 23,

1970

Mr. Robert Marlin

Sandor Pharmaceuticals
New Jersey 07936

Hanover,

Dear Bob,

Separately I am sending you a summary report and statistical
data of our two EEG studies of 8 42,548 in volunteers. In the
reported December 22, 1969, we defined a dose of
first study,
8
4.0 mg of 42,548 as adequate to alter the behavior of our
volunteer subjects.
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In the second study, reported here, we compared the EEG
profile of 8 42,548 to placebo. While many differences, particularly
in behavior and systolic blood pressure were observed, we were unable

to establish an EEG profile. As we discussed, the failure may relate
to the sample size or dose of 3 42,548 ~ or to the possibility that
its central effects are variable and unsystematic (at this dose).
There are two options that are of interest to us and meet
some of your needs. One is to extend this study by additional

subjects at 4.0 mg or by an additional 6»12 subjects at 6.0 mg,
in comparison to placebo, following this design. This will either
demarcate an EEG profile, or failing to do so, satisfy the
statisticians who may question our sample size.
The second

is to accept this data

and proceed with a

direct

comparison with dextroamphetamine in a larger sample. This compound
was the principal comparison in animal studies. If we define a
profile for dextroamphetamine and not for 8 42,548, we can be confident
that the CNS effects of 5 42,548 are less than amphetamine. Failure
to define a profile for dextroamphetamine will raise doubts as to
our technique.

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Hr. Robert Marlin

July 28,

—2—

1970

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Before concluding the present study, however, you may wish to
arrange a review of our data with other investigators of 8 42,548,
both within and outside Sandoz Pharmaceuticals. I am leaving for
my holidays in August, and would be pleased to participate in such
a meeting in early September.

statisticians to
their analyses of the data, trusting that their results

I would also be pleased to meet with your

review

are similar (but hoping they find

more

than

we

did).

Incidentally, the study took much longer than I anticipated
Now
largely by our need to improve our statistics and programs. with
that these are fully operational, I am sure we can proceed
greater ease.
My thanks for your cooperation in this study - and my best
regards.

Sincerely yours,
Max

Fink, H.D.

Professor of Psychiatry

Mszt

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