3 ms·
What I read is that they aren't looking for a multi-billion dollar profit. Which means that they don't have to work on a drug that they can sell to everyone.
by msandford 10y ago
What I read is that they aren't looking for a multi-billion dollar profit. Which means that they don't have to work on a drug that they can sell to everyone. Which means that they can focus on neglected areas of medicine for which the existing treatments are non-existent or terrible.
It's the difference between "proving" that changing a button color at Amazon makes people buy 1% more stuff (worth billions, probably) and "proving" it at a start-up. The start-up won't care about 1% more, but if you can triple sales, awesome! Even though tripling sales at a start-up might only be worth $500k, not billions.
When you're making HUGE inroads on efficacy it's much, much easier to demonstrate and you don't need thousands or tens of thousands of patients in the trial in order to get a statistically significant result.
- randcraw 10y ago1) However chasing unserserved markets doesn't reduce the cost of making a drug, it just diminishes the financial reward. 2) The regulatory threshold for efficacy doesn't change just because the drug maker isn't trying to make a profit. They'll still need the same rate of postive outcomes for a drug to get FDA approval. Yes, if a drug is deemed life-saving, the approval criteria may ease to expedite the approval process and lessen the thresholds for efficacy and toxicity. But such fast tracking applies only to critical care drugs and without regard for their potential market size or profitability. The need must be dire and unserved.