Ann: Shareholder Update, page-2

I’ll admit I am not an expert in validating medical devices, but the announcement appears to suggest the issues that delayed previous release dates has occurred again.

Why?

The Chairman's Address in Nov 2014  and 2014 Annual Report (October) both mentioned that all manufacturing machinery had been modified for the change in materials.

Today's announcement......
At the time we were convinced that the changes made to the device to allow it to be manufactured and distributed...

You don't build anything unless it is compliant with all regulatory conditions. The statement suggests Medigard were convinced what was designed would meet specifications. The rejection infers they didn't check or were advised (by sol-m?) it would pass validation. The former is a big 'my bad' on their behalf, the latter a possible claim on lost income and manufacturing changes. They even state in the same paragraph, "As is the nature of medical device design changes, there has had to be changes to the regulatory approvals for the BCD"

I'm sure the team is working hard, but with history repeating itself (despite assurances), the guarantee of a new release date of June 2015 is just another forecasted milestone.

The SP jumped on the announcements from late 2014, so the same potential is still there. It's just disappointing success is delayed ... yet again. I'll continue to hold for the results in June/July. Time will tell if I'm a sucker or patient.