Acceptable Risk by Robin Cook

“Where’s Edward?” Stanton demanded without so much as a greeting.

“He’s upstairs,” Kim said, pointing over her shoulder.

Stanton pushed past her and yelled for Edward to come down. He stood in the foyer with his hands on his hips, tapping his right foot. He was clearly agitated.

Kim’s pulse quickened. Knowing Edward’s fragile mental state, she was worried that Stanton would set him off. Stanton always operated as if he had no regard for other people’s feelings.

“Come down here, Edward,” Stanton yelled again. “We’ve got to talk.”

Edward appeared at the turn of the stairs. He was descending slowly. “What’s the problem?” he asked.

“Oh, nothing much,” Stanton said sarcastically. “It’s just that your burn-rate on our capital is out of control. This lab of yours is costing an ungodly amount of money. What are you doing, paving the johns with diamonds?”

“What exactly are you referring to?” Edward asked warily.

“The whole thing,” Stanton said. “I’m beginning to think you used to work for the Pentagon, since everything you order is the most expensive available.”

“To do first-class experiments you need a first-class facility,” Edward said. “I made that clear when we talked about forming Omni. I hope you don’t think you can buy such labs at garage sales.”

Kim watched the two men bicker. The longer they argued the less concern she had. Edward was angry but not out of control.

“All right,” Stanton said. “Let’s leave the cost of the lab alone for a moment. Instead I want you to give me a timetable for FDA approval of Ultra. I must know so I can estimate when we might see money coming in instead of going out.”

Edward threw up his hands in exasperation. “We haven’t even opened the doors to the lab and you’re talking about a deadline. We discussed the FDA issue at the restaurant before we agreed to form the company. Have you forgotten?”

“Listen, smartass,” Stanton shot back. “The burden to keep this operation afloat falls on my shoulders. Unfortunately it ain’t going to be an easy task with the rate you are going through our capital.”

Stanton turned to Kim, who was standing against the parlor wall. “Kim,” he said, “tell this thickheaded dork that fiscal responsibility is a prime requirement of startup companies.”

“Leave her out of it!” Edward snarled.

Stanton apparently sensed that he’d pushed Edward too far because he quickly assumed a more conciliatory tone.

“Let’s all be calm,” Stanton said, lifting his hands in supplication. “You have to recognize the reasonableness of my request. I have to have some vague outline of what you are going to do in this gold-plated lab so that I can try to anticipate and provide for our financial needs.”

Edward exhaled noisily and visibly relaxed a degree. “Asking about what we will be doing in the lab is a far different question than bursting in here and demanding a date for FDA approval,” he said.

“I’m sorry I’m not more diplomatic,” Stanton said. “Give me an idea of your plan of attack.”

“As soon as possible we’ll be launching a crash course to learn everything there is to know about Ultra,” Edward said. “First we must complete our knowledge of its basic chemistry, such as its solubility in various solvents, and its reactivity with other compounds. Then we have to commence controlled biological studies to understand metabolism, excretion, and toxicity. The toxicological studies will have to be done in vitro as well as in vivo on individual cells, groups of cells, and intact organisms. We’ll have to start with viruses, then bacteria, and finally higher animals. We’ll have to formulate assays. On a molecular level we’ll have to determine binding sites and methods of action. We’ll have to test under all sorts of conditions of temperature and pH. We’ll have to do all this before we file an investigational new drug application with the FDA, which is what you have to do before you can even start the clinical phase.”

“Good Lord.” Stanton moaned. “You’re making me dizzy. This sounds like decades of work.”

“It’s not decades,” Edward said. “But it is years. I told you that already. At the same time I told you that it would be significantly shorter than the twelve-year average development time for a drug.”

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