More tortuous misrepresentations by the emotionally challenged former employee and friend of the people at IMDS:
Kenita, please seek help.
On May 5, 1999,
Nassau County orally provided the Company with the following conditions in order
to begin the clinical studies:
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1. No patient information, i.e., mammography, ultrasound, and/or
ultrasound films or reports would be released to the Company until all
275 patients have been scanned,
2. NCMC medical staff would select, without the Company's involvement
and knowledge of the patient's condition, all patients that are
examined, and
3. IDSI was asked to pay 6-months of testing expenses in advance.
The conditions, as of May 10, 1999, imposed by Nassau County essentially prevent
IDSI from performing any comparisons until all 275 volunteers have been scanned
with the CTLM. These conditions are in direct contradiction to the previously
accepted IDE protocol, and have been caused, the Company believes, as a direct
result of the Miami Herald article and tortuous acts by certain individuals. The
Company believes that the "blind study" proposed by Nassau County would defeat
the purpose of the clinical investigational trials. If the Company accepts the
new protocol, in order to proceed with the study it would have to amend and
resubmit the IDE protocol.
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