The FDA approval process was just mentioned in the video as a possibility. It's not a requirement for this product to succeed or sell. It's already selling and seems to be selling at a nice growth rate based on what a couple other posters here have written.
You are right that gaining a meaningful percent of the market for ED products will take time. But it is a $20,000,000,000 market "today" and that market will only grow over time. Wouldn't take much of a share of the ED market to result in nice growth for this stock.
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