Would you believe IMDS if you don't believe me??
"We would rely on our independent bio-statistician regarding the actual number of case studies required; however, the FDA has the ultimate authority to determine the number of clinical cases needed for the PMA application. Like other governmental institutions, the FDA prefers to reserve the right to make bio-statistical determinations on an individual case-by-case basis. Therefore, it is very likely that a clinical trial will need to begin again, which will require approval by an IRB (Institutional Review Board)..."
Well, and here's a BIG LIE.
"As of May 2009, 10 clinical sites had participated in the clinical trial and at the time we believed we had sufficient clinical data to support our PMA application but only our independent biostatistician could make that determination. However, at the time we did not have sufficient financing to perform the statistical analysis study, support the clinical sites, initiate the reading phase and complete the submission of the PMA application to the FDA."
Because they said...
"In September 2008, we were advised that we did not have sufficient cancer cases to finish the clinical study required for the PMA statistical analysis to be processed by our independent bio-statistician. The clinical study participants were not from a pre-selected patient population. Therefore, we did not know whether the patients had cancer or did not have cancer before they participated in the clinical study."
So if you KNEW in September 2008 you didn't have enough data, then how come you didn't know in May 2009? Forgetful??
BTW, if they got all the financing they asked for back in 2008/2009 (and they did) and did not have "sufficient financing" as they claim, then how in God's name could they fund anything now at this price??
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