FDA approval won't make a lick of difference if they aren't making any profit on the product and revenue growth tapers off.
The US consumers purchasing the product don't care if it has temporary or permanent FDA approval. I doubt any would be even aware of the distinction.
Don't get me wrong, it would be a major achievement to obtain the approval and it is not a given. But the reward for doing so is simply that they are able to continue doing business, irrespective of whether that business is profitable or not. The downside is that they will need to spend millions more between now and late 2025 in order to obtain the approval.
FDA approval won't make a lick of difference if they aren't...
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