3 ms·
1) However chasing unserserved markets doesn't reduce the cost of making a drug, it just diminishes the financial reward. 2) The regulatory threshold for effic
by randcraw 10y ago
1) 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.