Not another collaboration! More tyre spinning. MEB's taken 2 and...

Not another collaboration! More tyre spinning. MEB's taken 2 and a half years to date from its announcement (below) yet to finalise a 60 person cohort for the John Hopkin's validation study (including about 50% of the cohort being normal). Surely, since the interim results publication on 21 December 2016 is it too much to expect the complete results soon? As for the publication of the 200 person cohort clinical trial results to support FDA clearance (scheduled to have started Q1CY17), who knows?

ASX MEB ANNOUNCEMENT Sydney, Australia – 5 December 2014: Medibio Ltd (MEB or the Company) is pleased to announce that it has appointed NAMSA, a respected US-based regulatory advisory and clinical research organization to coordinate its recently announced US clinical study to ensure that the Company’s depression validation study meets FDA regulatory requirements.
NAMSA with offices in Minnesota, California, and Ohio, USA has over 45 years of experience with medical device, IVD, regenerative medicine, clinical, bio-statistical and combination product testing services.  NAMSA has played an integral part in developing US domestic and international standards for testing medical devices, materials and combination products.  Its quality systems have been assessed by the FDA during multiple successful inspections; and their accredited and highly experienced experts have specialized knowledge in many regulatory jurisdictions.
NAMSA has begun work on protocol development and project implementation tasks, including presubmission consultations with the FDA. NAMSA will also liaise with the Black Dog Institute in Australia and Johns Hopkins University in the USA, to develop robust trial protocols to the highest possible standards. NAMSA will co-ordinate and monitor the US trial and prepare and manage regulatory submissions to the FDA. Working with both the FDA and MEB’s clinical research collaborators NAMSA will ensure that the Company’s validation study end-points meet FDA requirements, such that a successful completion of the validation studies will support a regulatory submission for approval to the FDA. Pending approval by the FDA and regulators in other jurisdictions MEB plans to launch its diagnostic for depression as quickly as possible.   ...
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About the US Validation Study Medibio recently announced that it had reached an agreement with Johns Hopkins University School of Medicine for Johns Hopkins to Conduct a clinical study regarding the use of circadian heart rate variability (“CHR”) designed to confirm the Company’s findings that CHR can provide objective physiological data to differentiate between individuals with clinical depression and individuals without clinical depression. The study will also assess the clinical validity of a proprietary software algorithm, developed by Medibio, that detects depression by measuring CHR variability clinically. The data collected from the study will support an application for FDA certification of Medibio’s proprietary software algorithm. The US study is expected to be completed within 12 months.

ASX MEB ANNOUNCEMENT Sydney, Australia – 21 December 2016: Medibio Limited (MEB or the Company) is pleased to announce the preliminary results from the pilot phase of its first prospective study of its Depression Diagnostic.  The principal investigators for the study were Dr. Naresh Punjabi (Professor, Johns Hopkins Medicine) and Dr. Francis Mondimore (Director, Mood Disorders Clinic Johns Hopkins Medicine).  The study analysis is based on full datasets from 26 subjects (11 with MDD, 15 healthy controls).  To generate measures of circadian heart rate (CHR), subjects underwent heart rate monitoring using a 3rdparty Holter (ECG) monitor for a period encompassing one day’s sleep cycle.