Challenges
What I THINK I know:
-1st qtr 2023, expected to complete enrollment
-1st qtr 2024 timeframe: end of the 12 month follow up monitoring
-2nd qtr 2024 (maybe??): PH 3 trial results
-9 months or so later: up for an FDA decision, so likely at the earliest, end of 2024 for the approval decision (??) 2+ YEARS from now
-still working to expand sales in overseas markets, but realistically, needs the US market approval
That said, then there is the bigger challenge to come and that is, breaking in/capturing market share from some established big market players who
i doubt will easily see their revenue stream 'interrupted' by an upstart. So the question will end up being one of, is this that much better than whats on the market NOW. Will it be that much better that a shift will occur simply because of the advantages/benefits of the design or will the market say, what we have is 'good enough' and the design is a tough sell, slow to gain market share if any.
As a disclaimer: I finally bought a few thousand shares at $1.14. And I plan to add more simply for the PR events to come (ie, completed enrollment, any planned data releases, NDA filing, et al cause they do get the markets attention. So while I expect there to be opportunities to see gains develop from this price level, I am not sold that this WILL get a good toe hold in the US market at this point in time. But given the low share count, I do see a move to $4-5/sh from this price level as achievable. Which is why I wanted 'some shares' before I get surprised by a jump for something I didn't see coming.
