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Sunday, June 10, 2018 12:48:49 AM
*Unblinding and data release can take more than 6 months.
*Data collection when accompanied by a survey adds time and must be compiled and analyzed before data lock.
*Data lock means nothing more can be added or changed including questionnaire results.
*The time before unblinding and data accuracy becomes especially critical when a 505b2 is involved since the object is to jump to a small Phase 3 trial or even market approval under a Phase 4.
*CROs tasked with data collection and compilation across more than 30 clinical sites makes unblinding even more time consuming.
The above are facts. Claims that 190 days indicate failure is as far away from being factual as any conjecture can possibly get. One might even call it fiction.
* Never borrow to invest.
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