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Actually, I think I know the answer to that. She’s dynamic, sharp, and commanding.
“The SSMRD will have to be consulted,” Karlene is saying. I pull out my notepad. Old school. Enzo laughs at the yellow legal pad I carry around, but it serves me well. For example, I’m able to figure out in two seconds flat the SSMRD stands for the Specific Subject Matter Review Division. Yes, I have a list of all the damn FDA acronyms. They’re out of control.
“Is that standard procedure?” I ask when she’s finished.
“With a drug such as this,” Karlene responds as she taps her finger on the conference desk, “yes. It’s nothing to worry about.”
“The bigger concern,” says the grey-haired man seated next to her, Randy, I think, “is the supervisory review. I know we’d originally discussed an October decision, but with the transition . . .”
I sit up. This doesn’t sound good at all.
“I’d expect at least a thirty-day delay. Does that sound right?” He looks at Ada, and so do I.
For reasons I don’t care to explain to a table full of near strangers, that’s absolutely not going to work for us. But I hold off on saying so and let her answer.
“I’d planned to talk to the sponsors about that”—she looks at Enzo and me—“but I won’t take up everyone else’s time. I know you’re all busy. Let’s get an update from each department first. We can stay afterward to discuss the timeline.”
Everyone seems more than fine with her proposal. They continue around the table, giving an update on everything from the clinical trial review to toxicity reports. I try my best to listen, but the possibility of a delay is the only thing I can focus on.
That and Ada. Every time she shifts position, I notice.
And I also notice every glance my way.
There’ve been at least three in the past hour. But none of them give any hint as to what she’s thinking. She seemed almost amused when she discovered who I was, but she’s all business now.
“Do either of you have any questions for the team before they leave?”
Enzo asks the medical officer a question. As always, he’s much more hands-on with the actual product. A chemist, and the person who actually made the discovery, he takes point on all things science-related. Honestly, he doesn’t really need me here, but we set the terms of our cooperation more than a year ago, and neither of us stray from them.
On the other hand, FDA approval is a make-or-break part of the business, which means both of us have been as involved as possible even though Enzo takes point.
“Any other questions?” she asks.
I’m smart enough not to answer. It’s like a college professor asking for questions at the end of class. After the bell has rung. No one dares to say a word, and I won’t be the one who’s responsible for keeping the team in this meeting. Especially since I’m eager to get to the whole timing conversation.
“OK, thanks for coming, everyone. If you gentlemen can stay, we have a few things to discuss.”
When they leave, a very awkward silence descends on the room, making it feel a little claustrophobic. No windows. Bare, cream, clinical walls. Exactly the opposite of the look Enzo and I will be going for when we secure our new office space.
“You mentioned a possible delay,” Enzo starts.
Ada nods. “As I said, ideally the entire review team remains intact from start to finish. It’s even less desirable for the RPM to change mid-process.”
RPM. Regulatory Project Manager. Aka Lauren Conrad. Aka Ada Flemming.
“I apologize for any inconvenience, but a thirty-day delay is standard. I’ll need time to fully review the case, which I’ve already started, of course.”
No, no, no, no.
“With all due respect, Ms. Flemming—”
“Doctor Flemming,” she corrects me. Dammit. Of course. Almost everyone here is either a medical doctor or PhD.
“I apologize. Doctor Flemming.”
Has she ever been naked on a boardroom table?
Doubtful.
