why do you have to make up lies to persuade people that your cause is just?
You said: Nassau Medical Center Original Protocol
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.
3. IDSI was asked to pay 6-months of testing expenses in advance.
4. No publicity.
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On April 19, 1999, the Company's applications specialist arrived to work out the
day-to-day working relationships between her and the Nassau County staff. During
these discussions it was learned that Nassau County was trying to change the
protocol of the IDE even though it had already been reviewed and approved by
both the Nassau County IRB and the FDA. The Board of Nassau County had
arbitrarily decided not to allow Company personnel access to the mammography
films and, where available, the ultrasound and/or magnetic resonance imaging
(MRI) images until after all 275 patient scans were completed.
On April 19 and 20, 1999, letters was written to the Medical Director of Nassau
County and the two principal investigators, respectively, to discuss the new
requirements. Nassau County did not respond to either letter. On May 5, 1999,
Nassau County orally provided the Company with the following conditions in order
to begin the clinical studies:
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. Nassau County medical staff would select, without the Company's
involvement and knowledge of the patient's condition, all patients that
are examined, and
3. the Company was asked to pay 6-months of testing expenses in
advance.
The conditions imposed by Nassau County essentially: (i) prevented the Company
from performing any comparisons until all 275 volunteers have been scanned with
the CTLM(TM); (ii) posed a risk that the patients selected by Nassau County may
not be appropriate due to Nassau County's limited knowledge of the CTLM(TM), and
(iii) require payment in advance for 6 months of testing expenses for a three
month study. Conditions (i) and (ii) were in direct contradiction to the
previously accepted IDE protocol and oral agreements with Nassau County, and
were caused, the Company believes, as a direct result of the Miami Herald
article and tortuous acts by certain individuals.
The Company has no objection to paying reasonable and customary testing expenses
actually incurred by Nassau County, however, the Company believed that the
"blind study" proposed by Nassau County would defeat the purpose of the clinical
investigational trials since the IDE clinical trials were designed to be a
learning process, i.e. a series of studies, one building on the other. Each
study builds the knowledge base on which to better interpret the next study. A
"blind study" is used to determine the effectiveness of a device after the
interpretation criteria has been established. A "blind study" without
established interpretative criteria serves no clinical purpose. In addition, the
Company believes that the review of all 275 cases at once time instead of on a
daily or weekly basis would (i) multiply the complexity of the task; (ii) add at
least 90 days to the IDE before the Company could develop interpretive criteria;
and (iii) prevent the Company from making adjustments to the software or
hardware of the CTLM(TM) that would improve the quality of the study.
On June 21', 1999, the Company received written representation from Nassau
County that the Company could begin the clinical investigational trials pursuant
to the original IDE and the payment of reasonable and customary charges for a
three- month study. On July 8, 1999, Nassau County and Company personnel began
scanning patients for the clinical investigational trials.
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That is as blatant of a misrepresentation of a stated material fact as it gets. That is a lie, kenita. That is no mistake. No accident. And, you state it as factual, so it is not dismissed by your ambiguous terms like "it seems" and "apparently". You li. |
