[Letter to Jean-Pierre Allain from Jesse C. Dobson]

GOLDEN GATE
January 9, 1991 111 111111111111
5571095.0281.019
Dr. Jean-Pierre Allain, Director
Medical Research, Diagnostics Divisioa
Abbott Laboratories
Abbott Park
North Chicago, IL 60064
Dear Dr. Allain:
We are writing to request a meeting to discuss the design and implementation of our
proposed trial nf your HIV1G product versus conventional IVIG, We feel that such a
meeting is necessary to make sure that we fully understand one another's perspectives
on th is en couragin g treatment approach, We also wish to discuss the scientific
logistical and financial barriers to executing our proposed protocol, As you probably
know. we havt subtnit:d a c.incept sheet to the Community Consortium in San
Francisco headed by Dr Donald Abrams. The most recent version of the concept sheet,
which is in its second revision, is enclosed. The points that we wich to discuss with
Abbott include:
IJ Abbots approval *trategy for ITIVIG as a treatment for those Qiready infected
with liY We are await of your planned trins inifa i im hu ACT;. We would like
to divcus s what impact you feet that these triats would have on approval of IllVIG for
adults at various stages of IlV disease.
2) Rwruitnwnt vi paticiits and donuts, In con junction with the PATH Project, we
feel we have the resources to quickly recruit donors and patients in San Francisco. By
working with Dr. Dofry Liprov at Children's Hospital here. we also feel we would have a
center for safely collecting plasma. processing it for shipping both for conversion to
HIVIG and for proposed exotic irnmunological tests In order for us to undertake the
considerable effort to make this happen, the benefit to our community would be need to
be made clear to make the efforTL worth our while.
3) Reporting of data We are interested in reviewing any basic immunologic and
viral markers (e.g., anti' gpl2O activity) data indicating the efficacy and mechanism of
action of HTVLU. We would very much like to review these data as we think they are
critical to the scientific commuinity's perception of IUJYIG's potential efficacy. Also,
when will the results of the upcorni rg pediatric trial be available quickly?
4) The extent "f AIbmts financial participatimn it) (ir proposed trial, While we
think that we may Ve able to airrange for pai iaI funding frnn public sourwes of such a
program, AhhIott s increased participation woulkd give us grearer control over the
execution 4f the triat and Abbott greater control rwer the resulting data. In any case.
we need the cost {4 product ng prudiiit per Pativllt to accuiratety estimate the anwunt 01
mioncy to he raised. As the con ept sheet shows &he Iriat would be aimed at people with

--------------------------------------------
---------------------------------------------