Ann: Medibio Hosts Call to Discuss Clinical Validation Study, page-11

I agree @13th. If you're looking for negatives, you will find them. Here are some positives from my notes this morning:

There is no predicate device. meb are "working with FDA to reach a common path to demonstrate clinical significance" A negotiated outcome perhaps?

Medibio engaged the FDA in the pre-submission process to verify the its novel nature and that no existing classification or predicate device is on the market.

Regarding market utility: The medibio depression diagnostic algorithm is used when an individual is suspected to have a moderate to severe depression. The algorithm will generally be used once per episode of suspected depression or maybe used multiple times should multiple episodes present.

Medibio’s test will be favourably looked upon by the fda because it's sensitivity and specificity of 70% is considered superior than other methods.

One of the clinicians on the call stated that there are currently no objective data available for clinicians. Diagnosis currently relies on only subjective data, so a clinical support monitor with 70% accuracy will be very appreciated by clinicians. The objective data will not only improve diagnostic accuracy but it can be used as a baseline for ongoing monitoring of the patients response to treatment. Another advantage is that the clinicians can access the data remotely so that early physiologic indicators can be assessed in real time and adjustments to treatment can be made early enough to avoid further deterioration, so clinicians can be proactive rather than reactive. Having an objective measure is a significant enhancement to a diagnosis that was never available previously.

I thought it was interesting that the legal advisor answered the question about the FDA response. The team was obviously counselled to not provide any indication of likely success. A conservative and predictable response I think.

It was mentioned that there is no gold standard of diagnosis and medibio may well set that standard; and that the denovo application implies that meb is unique in the field.

Brian Mower's closing remarks were that they are happy with the clinical results and that they are planning some big things for the future. He was hopeful that shareholders were provided with comfort that meb has a strong team and strong support from external advisers to work through the fda process to obtain the company's denovo application successfully.

There are many well qualified people on the meb team and my general impression was that they are quietly confident of success. Time will tell.