This info was included in the recently filed S-1:
Bernard Friedland, President of the Company, as sponsor, filed with
the FDA on September 20, 1984 an application for a study, on human subjects, of
the efficacy of RETICULOSE upon AIDS. In response to two deficiency letters
from the FDA,, the Company on March 6, 1992, submitted to the FDA additional
information, including findings from independent research laboratories
intending,, among other things, to procure the FDA's approval to conduct Phase I
human trials for RETICULOSE. On July 31, 1992, the Company received a further
deficiency letter from the FDA (the "July 1992 Deficiency Letter"). The July
1992 Deficiency Letter provided detailed comments with respect to chemistry,
toxicology, microbiology and clinical areas requiring further studies and action
on the part of the Company. To date the Company has not formally responded to
the July 1992 Deficiency Letter from the FDA. The Company presently contemplates
that it shall either file an amendment with the FDA seeking to reactivate the IND that had been previously filed with the FDA, or
withdraw such IND that has been deactivated by the FDA, and filing a new IND
application. The Company intends to allocate certain funds from the exercise of
Options, provided at least 25% of the Options are exercised, for the purpose and
filing a new IND with the FDA. See "BUSINESS - CURRENT STATUS OF TESTING OF
RETICULOSE". No assurance can be given, however, that any Options will be
exercised, or that a new IND will be accepted by the FDA or that any tests
previously conducted or to be conducted will satisfy FDA requirements. See
"BUSINESS - BACKGROUND OF RETICULOSE" and the "CURRENT STATUS OF TESTING OF
RETICULOSE." |
