Earlier today, ODAC... the Oncology Drug Advisory Committee... met to vote on our application for [Product] in [new indication].
There were two possible outcomes. ODAC could vote to approve our application and send it on to the FDA for action... or ODAC could decide that additional information and revisions to the application were necessary in order to gain the Drug Advisory Committee's approval.
They chose the latter course.
We're disappointed by the vote, because if ODAC had voted to approve, our company would have been able to bring this product to the market earlier... and get it to patients earlier.
It's safe to say that the members of the Oncology Drug Advisory Committee were also disappointed to reach this verdict, because the data available on the use of [product] in [indication] –– clearly indicates that our product represents a huge step forward in treatment.
If that's the case... why didn't ODAC vote to approve? What, specifically, does this request for revision and additional information mean... to the product, to the company, and to all of us?
That's what I'd like to talk to you about for the next few minutes... because it's very important to understand the context of this decision. And it's very easy to misread the nature of this decision – easy to make assumptions, draw inferences, and come to conclusions that completely miss the mark.
When your goal is to bring a breakthrough to the market...
When your plan is to create a new standard of care...
When you're working to provide the answer to an existing medical need that's never been effectively addressed...
...that's a different and far more difficult process... than working in an established therapeutic category to create the next incremental advance.
When you're truly committed to the delivery of innovative therapies, you can pretty much predict... and expect... a little bit more than your fair share of disappointments.
You're going to need more resilience. You're going to need a higher level of personal commitment...and corporate commitment.
At [company], we've asked for that commitment... and we've offered that commitment in return. We have the best in the business working here... because we need the best in the business... in order to do the things we want to do...
Right from the start, we've known that the clinical areas our company chooses to focus on... the innovative therapies we work to develop... have a higher degree of difficulty... and a higher degree of risk. They also offer a higher degree of reward. That's the trade-off.
And... because it's more difficult... because the risks are greater... you'd think that we would lower our expectations in certain situations... like regulatory approval.
I suppose you could make a case for that, but as each person in this room knows, we invest all of our work with high expectations. Our corporate culture supports and nurtures high expectations.
The only disadvantage to high expectations... appears in the form of heightened disappointment... at those moments when progress slows, or we learn that we need to go back... when we want to move forward.
To our credit... while we have been disappointed... we've never been disheartened.
Our work is too important. Our promise is undeniable.
The FDA is not our "enemy." They're a partner that shares many of our corporate goals. The FDA wants to see our innovative products reach the market, because the FDA recognizes that the medical needs we're addressing are "unmet."
That's precisely why the FDA granted a "priority review" designation to our New Drug Application just four months ago.
Priority Review is given only to products which, if approved, would represent a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease...
