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Re: berthabluefish1 post# 8214

Tuesday, 02/14/2017 7:49:10 PM

Tuesday, February 14, 2017 7:49:10 PM

Post# of 27424
Hi Bertha. I tuned into the presentation this afternoon. I thought Dr Chan did a nice job in the little time he had to speak. He was upbeat, informative and in command.
He reviewed the science behind the device to the new investors. Not much new to us veterans but a good review.
Dr Chan highlighted and emphasized the importance of the $18M the gov't has granted us over the years to help us develop the device; he explained the advantages and importance of the expanded partnership with Fresenius; talked about the launch of the cartridge from Terumo in Dec; and touched upon the partnership with Biocon. It all sounded impressive from an investor viewpoint. I liked it. It enhanced my optimism.
He then spoke about the upcoming REFRESH II to begin "later this year". Here's where he mentioned the PMA path to approval. He mentioned it quickly so I was glad I was paying attention. This is not the path we want. A PreMarket Approval is the long and expensive route to approval. If you recall from the previous Q3 report, Dr Chan was hopeful of the shorter 510k route. We should get some clarity at the upcoming Q4 review.
I don't expect much difference from tomorrow's presentation since they are less than a day apart.
Hope that helps.
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