2020’s NDA list is packed with commercial firsts — from historic to haphazard. Have we reached a tipping point?
In drug R&D, a successful late-stage development program is like a widely shared celebrity love affair. Analysts will swoon over peak sales projections. Developers can hug themselves for a job well done. Even regulators get in on the act, bullish at officiating over a higher standard of productivity, with a nod to breakthroughs and new first-in-class drugs to contemplate.
This is the time for rose-tinted glasses.
Then if and when the approvals come through, the love affair gets to look a lot more like a marriage.
Now you actually have to sell the drug after years of promoting its future. If a commercial hardship develops, you get to put your head down and work things out, one way or another. And for an unforgiving Street, there are no excuses for any lapses on the numbers.
You go from making promises, to keeping them. Or the board will find someone who can.
This is the new reality for 24 biotechs that boasted of a first drug approval in 2020 — close to half of the 55 companies that claimed all or part of one or more new drug approvals last year.
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