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“As you can imagine, we have our investors to consider. Our ability to go to market with our product in a timely manner relies on your approval.”
“Not my approval. FDA approval. And that is usually the case with any NDA.”
I have a mind to tell her “New Drug Application” isn’t all that much more difficult to say than NDA. And that her organization seems intent on excluding outsiders with their internal communication and lingo. But I don’t think she or Enzo would appreciate a lesson on exclusive language as a form of subtle ostracism.
Nor will it help our cause.
But still.
“We’re as invested as anyone in making sure the antidote is safe,” I continue, “as it’s been shown to be in all of our preclinical and clinical trials—”
“There is a process,” she cuts me off, “for a reason, Mr. Tanner.”
She’s annoyed. And I should probably back off, but the thought of telling my father we’re looking at no less than thirty days, right after I assured him the shift in staffing wouldn’t be a problem . . . no. I can’t do it.
“I understand . . .”
“Hayden,” Enzo tries to intervene. But I’m not finished.
“We certainly don’t want to undermine that process, but any delays could very well alter the face of this entire enterprise.”
It sounds dramatic, but my words are one hundred percent true.
I don’t dare look at Enzo.
Ada sits back, watching me as I do her.
That’s when I see it. The very same look she gave me outside the ladies’ room. Not that it matters. I won’t be lowering my bucket into that well.
“I can appreciate your position. I’ve yet to work with a sponsor whose life savings or life’s work wasn’t somehow tied to FDA approval. But that doesn’t change the process.”
I lean forward. “The process, no. The timeline, yes. It’s through no fault of ours thatyouragency has caused a delay because of staffing issues.”
Her body position doesn’t move. But her eyes . . . they’re not as cool and collected as the rest of her. They’re spitting fire at me, actually.
“I’m new to your case and will need time to properly review it. What exactly do you want from me, Mr. Tanner?”
Oh, now that’s a loaded question.
“We understand,” Enzo butts in. “What my partner is saying is just that we’re on an extremely sensitive timeline because of our unique investment agreement.”
“I will do everything I can to shorten the delay. But you must understand my position as well.” She turns from Enzo to me. “If there are any missteps on my part, my boss might deny your application.”
Are we talking paper-pushing missteps or something else? I’m pretty sure she just gave me a loud and clear message to back off. Not that it’s needed.
“We appreciate that,” Enzo says. And just like that, the meeting is over. He stands. She stands. I have no choice but to concede.
“You are the main point of contact,” she says to Enzo. “Am I correct?”
He walks toward her and shakes her hand. “I am. And I look forward to working with you.”
Before I can reach them, she turns to me, nods, and then begins to walk away.
“I’ll send someone to show you out.”
Just like that, she’s gone.
Good riddance.
