Advisory Committee last Friday, he had been evading her questions about the drugâs status. Sheâd attended the meeting, sitting in the first row seat Jake had secured for her, even though she and Jake had to conceal their relationship. The Advisory Committee of outside experts in organ transplant surgery, academicians primarily, had been tasked by the FDA to review the data on Immunoneâs safety and efficacy, both data as prepared by Keystone Pharma and as prepared by FDA reviewers. After listening to the companyâs and the FDAâs prepared presentations, the committee responded to a list of questions compiled by the FDA.
A titular chairperson conducted the meeting, but Jake, as the FDA Immunone project manager, ran the show behind the scenes. He had selected the questions, chosen the order of presentation, controlled the timing, and compiled the notes. He had to know everything. So why wasnât he telling her?
No one was more pleased than Addie with the meeting outcome. The FDA panel of consultant scientists clearly indicated the drug should be approved. Naturally, the company scientists did too, but of all the presenters, Addie thought Keystone Pharmaâs consultant, Dr. Laura Nelson, made the most compelling argument. A transplant surgeonwho led the Immunone clinical studies, her data highlighted the number of lives that would be saved if the drug were approved. Her message: the transplant process is so arduous for recipients and donors that when the body rejects the organ, failure amounts to tragedy. Immunone decreased the chance of rejection, according to Dr. Nelsonâs studies, by more than 70 percent. The thought made Addie shiver with pride. Immunone was
her drug
. Sheâd discovered it when she was a grad student at Michigan, and sheâd nurtured it through its development at Replica until Keystone Pharma acquired all rights for an insane amount of money.
Addie was impressed by how well Keystone had done by Immunone. For the last year it had been their number-one priority, and theyâd convinced the FDA to fast track it. She had every reason to feel optimistic, yet she didnât. There was something Jake wasnât telling her. He acted like he was trying to protect her, to shield her from bad news. She wondered if it had anything to do with the death of Dr. Minn, the Keystone scientist who got killed last weekend? But how could it? The FDA had all the data. All that remained was the final approval.
Addie glanced at the clock on the wall. Almost five. Jakeâs wife would be away for two more nights. Sheâd better get home before he got to her place. She didnât want him lurking outside her apartment, attracting the neighborsâ attention. She started to pack her notebook in her briefcase when a business card fell out. She picked it up, turned it over: âDr. Laura Nelson, Chief of Surgery, Tampa City Hospital.â
During the break at the Advisory Committee meeting, Addie had approached the attractive doctor, introduced herself; theyâd exchanged cards, and Dr. Nelson had encouraged her to call if she ever had any questions about Immunoneâs performance in the clinical studies. Addie had considered her offer most generous, and she would have liked to talk to her longer, but the FDA committee chairman had interrupted.
What about calling Dr. Nelson? Would she reveal whether there could be any problems with Immunone? No, better wait to see what Jake had to say. Sheâd put more pressure on him tonightâlike female spies did in espionage movies. Jake may be old, but he was a sex machine. If something were wrong with the Immunone approval process, sheâd find out tonight.
CHAPTER SIXTEEN
W EDNESDAY , F EBRUARY 19
âHey there, sleepyhead.â Tim stood at Lauraâs side, gazing down on her. âAbout time you woke up. Never had such boring company.â
Laura drifted into consciousness as the sky outside her lone window