“You don’t believe me.”
“I don’t know yet,” he said. “Why all the secrecy?”
“GX-42 is an experimental drug that hasn’t yet been FDA-approved for clinical trials.”
“You mean on people.”
“Yes. How much do you know about drug development?”
“Give me the version for dummies.”
“By the time a new drug is marketed, it’s been put through rigorous and endless testing. It must pass through three stages. That doesn’t sound like many, but each stage of testing stretches out for months, more often years.”
“Okay.”
“That applies to your everyday big money-makers with a large market, like a new beta blocker or anti-inflammatory. It’s an even longer process for an orphan drug.”
“What’s that?”
“A drug being developed to treat a rare disorder. It would benefit a comparably small number of people.”
“So those drugs get low priority.”
“Not as low as they got before the Orphan Drug Act was passed several years ago. But research funding relies almost solely on grants. GX-42 is an orphan drug. But this company has devoted personnel, money, and years to developing it. It’s passed the first two stages. Clinical trials are the final. GX-42 has been submitted, but as yet hasn’t been approved.”
“And your patient can’t wait around for it to get the green light. There’s nothing you can do to hurry the agency along?”
“There is what’s called expanded access. Compassionate use. It’s an exemption made for a patient when all other treatment options have been exhausted.”
“Last-ditch effort.”
“Yes. The FDA is open to granting these exemptions, but certain criteria must be met. The requirements are stringent. The request must be filed by a physician for a particular patient. Nate and I have applied for one. The review board is still considering our application.”
Rye assimilated all that. “So, the box. You had the drug smuggled in from another country where it’s already in use?”
She had no reason whatsoever to trust this man. If what he’d told her was true, he lived the life of a vagabond. He was rude and came across as being self-interested, indifferent to anyone’s welfare except his own.
Yet he felt obligated to his friend Dash for the loss of his airplane, and to Brady White. He’d intervened when the aviation memorabilia was about to be dusted with black powder. Marlene White had seen some honor in him, or she wouldn’t have trusted him with her car.
What Brynn had to tell him was a thousand times more consequential than the loan of a car, but she was convinced that he wasn’t going to end this standoff until she enlightened him, and she had little time to spare.
“No,” she said. “There’s a similar drug being tested on a small group of patients in Europe. GX-42’s capabilities exceed that one.” She looked across at the box. “Last night, a single dose was smuggled out of the lab.”
“Something Corp. I saw the name on the air bill.”
She nodded. “Researchers there have seen amazing results in test animals. They trust the drug’s safety and effectiveness. Nate and I trust them.”
“You believe it will work.”
“I believe it’s worth trying on patients who have no other hope, and who are being denied even that hope because of a rubber stamp.”
“These patients have nothing to lose.”
“Except their lives.”
“What about negative side effects? Could it make the patient worse off, not better?”
“That’s one of the beauties of it. During the past year of testing, the lab animals that died did so of the cancer, but didn’t suffer any harmful effects of the drug.”