"At its July 29 meeting, the Subcommittee agreed that 
the supporting data base for the proposal submitted by 
Drs. Anderson, Blaese, and Rosenberg was insufficient 
and recommended deferral of consideration of the 
proposal until this information was available. As an 
aid to the applicants, the Subcommittee listed the 
three points this data base should address with respect 
to animal testing and two additional issues with 
respect to the human TIL into which the vector has been 
introduced. 
"The Subcommittee felt that provision of the requested 
data was well within the range of present technology 
and could be provided without unreasonably delaying the 
proposed clinical research. 
"A telephone conference was held on September 29, 1988, 
by the Subcommittee to review additional data submitted 
by the applicants to determine whether or not there was 
now a data base sufficient to act on the proposal. 
Again, the conclusion of those participating in the 
telephone conference was that although some progress 
was made, we were not yet in possession of the 
requested information and our recommendation of July 
29, 1988, therefore stands unchanged. 
"As an aid to the applicants and the members of the 
Recombinant DNA Advisory Committee, the minutes of the 
telephone conference are appended to this summary which 
include evaluation of the specific data submitted by 
the applicants with respect to the points at issue 
raised by the Subcommittee." 
Dr. Neiman said the minutes to which he referred were still in 
rough draft form. Many of the participants had not had a chance 
to review them, but they were provided for RAC members to get a 
flavor of the concerns on specific data. 
Dr. McGarrity thanked Dr. Walters and Dr. Neiman for presenting 
the historical background and history of the proposal. He said 
he felt compelled to digress from normal procedures because a 
discussion of the issues with Drs. Anderson, Blaese, and 
Rosenberg would be more efficient in dealing with the many issues 
and called on Dr. Anderson to lead the discussion of the 
proposal . 
Dr. Anderson said the primary issue of concern was raw data on a 
number of issues that were not present in the mailings. He said 
the reason why these data had not been supplied to the 
Subcommittee to date was because both Subcommittee meetings and 
the RAC meeting itself were open to the public. Releasing this 
Recombinant DNA Research, Volume 13 
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