The lottery is also binary, you either win or you don't.
Also, consider that approval isn't everything. It is just another milestone towards getting cash flow.
Even if MSB gets approval, this isn't a guarantee the product will be a success. There will be ongoing analysis of the data (phase 4 trials) so we had better hope we do have robust results - many products get pulled after approval.
It's a very expensive product, so it also had better be superior to current standards of care - many of which it isn't being trialled against.
For example, it showed a modest reduction in pain score (but no functional improvement) compared to saline for CBP. But what about against steroid injections, which are 1/100th of the price.
Even if we think it's superior to steroids, we want patients and doctors to be convinced enough to fork out the money.
Also keep in mind, revenue growth from existing products in approved countries is slowing already - this is something to keep an eye on, and no one here has offered a reason why this is.
Either the market isn't as big as we thought, and it's already becoming saturated, or the product isn't working in the real world as we had hoped.
This is one of the major issues with designing trials to succeed, rather for them to hold validity.
Using saline as a control instead of HA - sure, FDA says it's good enough to get approval. But will the customers be convinced (who are likely know how to interpret studies)?
So approval isn't the end game. That's just the beginning. Those "triple digit returns" on approval simply bring you back to prices you were at last year.
Then the real test comes - whether people want the product, whether MSB can expand production (notoriously difficult for this sort of therapy), whether the product stands up against analysis in the real world.
GLTAH. But things aren't really as binary as you think
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