Saying management were "hasty", "blown away", using the words...

Saying management were "hasty", "blown away", using the words "mis-step" and so on is just wrong.

See this article here:

https://www.upi.com/Top_News/US/2021/09/15/medicare-rule-breakthrough-devices/5171631666591/

Let's be clear, the feedback from the FDA was not a "no" it was requesting more data, which will be achieved via the pivotal trials which were going to take place regardless of BDD or not, once more data is gathered through more scans both from the remaining 20 patients and the pivotal trials, there is every chance BDD will still be granted for EMV's brain scanner once that data is sent to the FDA.

The article above and the CMS's threat to go back on their automatic reimbursement of all devices which achieve BDD status upon full regulatory approvals. Regulatory approval and BDD are two very different things which I would hope all shareholders in EMV understand, management were NOT applying for regulatory approvals without sufficient data, they were applying for BDD, which gives no indication of data required, but criteria to meet, which EMV meets. Hence the answer was not "no" it was wanting to see more data...

Given that the CMS is reviewing this topic, I would not be surprised if the FDA have tightened things up at this point in time and are probably telling many companies who would have been granted BDD status, instead to provide more data (or possibly stand to lose the automatic reimbursement for BDD's - arguably the most valuable part of the BDD!) as mentioned in the article I posted above:

"In its proposal, the CMS said it had "significant concerns" about the availability of clinical evidence for breakthrough devices when used on Medicare recipients, which could lead the program to pay unnecessary millions to cover unnecessary products."

I suspect when EMV applied for BDD, it would have been a shoe-in but unfortunate timing with this review by the CMS has lead to the FDA demonstrating to the CMS that they are now making applicants show more data as this helps their chances of the CMS not revoking this advantage of BDD.

To think for even a moment that management have made a mis-step by applying for BDD at this point in time is absurd. This is not their first rodeo. There has been absolutely zero impact to the timeline of EMV commercialising the brain scanner.

I hold a lot of shares in this company and I sleep very well at night knowing we are in the hands of the best.