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Sunday, November 17, 2019 11:54:12 AM
As for the CR itself. It appears to me that Avita is seeking to build a wide moat for their tremendous product by going after FDA clearance for numerous applications ASAP. I have worked for a US fortune 500 Medical Technology Company for 32 years. I'm familiar with what it takes to get through FDA (whether it's a 510K submission, or an even more difficult PMA). I understand the huge time, money, resources and clinical trials that are required for this - having been involved in more than a dozen of them myself. Someone had mentioned competitors in a previous posting. If Avita obtains FDA clearance on the applications they mentioned in the CR announcement over the next few years, they will have such an enormous head-start on any potential competitor that it will be quite discouraging for someone to come after them. I'm not saying it's impossible, but it will make them count the cost very carefully - knowing how far they'll have to go and how much it will take - just to "get in the game" - let alone take significant market share. Don't forget, it isn't just the technology they need to develop (which Avita will be seeking to restrict with additional and extended IP claims) but the manufacturing capabilities, quality systems, sales and marketing teams, vendor qualitfications, establishement of distribution channels, etc., etc., etc. This is why I like that Avita went for the CR now! Additionally, notice that they mention "highly de-risked pipeline". This is critical because it provides a high degree of confidence (based on real studies) that the new applications will meet the necessary requirements when the time comes. That is extremely good news. Having been part of the technology evaluation team - where we look at new technical advances, start-ups (now called unicorns), etc. I can say that the vast majority of them do minimal studies to "prove" their technology works - until we test it and find otherwise.
My apologies for the long-winded post. Best wishes to everyone!
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