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“I’m only telling you now because she wants me to get in touch on Monday and set up a meeting as soon as possible. If it’s something that can be designed and implemented fairly easily, it might not cause a delay at all.”
“You mentioned good news?” His voice is clipped, which is completely understandable.
“I don’t know where she’s at with this exactly. I was serious when I told you that my job is to gather all of the data, not make decisions.”
If that were different, this call wouldn’t be happening. This relationship would be indefinitely on hold too.
“But thereisgood news. We typically don’t talk about Phase IV studies on NDAs that aren’t in the pipeline for approval.” I wait for him to catch my meaning.
“You’re saying you think this will be approved?”
Oh shit, I almost missed my turn. Resituating myself and looking at the navigation, I answer his question as honestly as possible.
“I’m saying that I’ve been asked to bring you in to discuss a potential Phase IV study. And by definition those aren’t necessary for drugs that haven’t been approved. That’s all I can say without compromising more than I already have.”
“How long of a delay?”
I knew he would ask that question.
“That’s impossible for me to say. The study may not even be warranted. That’s what the meeting is about. If it is needed, there could be no delay at all. Or a minimal one. Or, if it’s complex enough, it could be weeks. Or months. There isn’t a single answer. All drugs are different.”
More silence.
“So it looks like I’ll be coming back to your office sooner rather than later?”
“Yes.”
Is he upset about a possible delay? Happy there are signs it’ll be approved? Based on everything I know, both from his case specifically and others I’ve worked on, approval is a forgone conclusion, but I don’t dare tell him that. It’s only my opinion, and again, I won’t be making the ultimate decision.
Thank God.
Still, things are getting complicated already, and only a few people know about us. How much more complicated will our relationship get if this process takes months longer than expected?
“Enough work talk,” he says, his tone more lighthearted, “tell me something about you I don’t know already.”
I settle in for a long drive, grateful to have Hayden to keep me company, but my mind can’t stop whirring.
Hayden didn’t say it, but I know he’s scared. Terrified, actually, of the possibility that his father might become an integral part of a business he and Enzo created. And as little as I enjoy thinking about it, there’s no denying the fact that the actions of my team, my boss, will directly affect the course of Hayden’s life.
If the NDA isn’t delayed because of the study, it just might be anyway.
Because of me.
And that thought isn’t sitting well at all.
31
Hayden
This time, I’m early to my meeting at the FDA, partly because I didn’t get to see Ada all weekend. Karlene’s birthday was Sunday, it turns out, and I couldn’t steal her away like I wanted to. Nor could I attend Karlene’s surprise party, because other FDA employees would be there.
When I enter the lobby, Ada is nowhere to be found. I texted her on my way in, but she didn’t answer. An administrative worker sitting behind her desk is looking at me suspiciously.
“Mr. Tanner?”
I turn, unable to place the voice.
“Hey, Qasim.”
