A small biotech company called Brainstorm Cell Therapeutics Inc. is among the first companies considering selling an experimental therapy directly to patients under the “right to try” measure, signed into law late last month. And if the company moves forward, it may give its unproven therapy a price tag in the ballpark of $300,000, according to a recent report by Bloomberg,

The experimental stem cell-based therapy, called NurOwn, is aimed at treating amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). But despite the potentially hefty price tag that patients would likely pay out of pocket, there’s no evidence that the therapy stops the progression of the disease or improves symptoms. So far, NurOwn has only passed early clinical trials showing safety, not efficacy. But under the new “right-to-try” law, the biotech company doesn’t need such proof to sell its therapy.

The law was pitched as a compassionate measure to allow patients with life-threatening illnesses easier access to experimental drugs. But the bill was controversial, with critics noting that the Food and Drug Administration already had a swift and lenient pathway for such patients to obtain experimental drugs. Critics also worried that the law would simply weaken the FDA and open vulnerable patients to unscrupulous companies that might try to peddle unproven—and potentially sham—therapies as profit-driven endeavors.

In a feisty letter to the FDA, Senator Ron Johnson (R-Wis.), who sponsored the right-to-try bill seemed to confirm some of those fears after the bill was signed into law. He made clear to the FDA in the letter that “this law intends to diminish the FDA’s power.”

Now, Brainstorm’s potentially eye-popping price range for NurOwn is stoking fears further. The company—which has no other product on the market or source of revenue—is considering launching NurOwn as a profitable venture. Based on an interview with Brainstorm CEO Chaim Lebovits, Bloomberg described it as a “semi-commercial enterprise with modest profits.”

“Companies cannot be NGOs [non-governmental organizations],” that provide charitable aid, Lebovits told Bloomberg. “We have to have an incentive.” In discussing possible pricing for NurOwn, he referenced other cell-based therapies, which have price tags of upward of $375,000.

The office of Senator Johnson didn’t respond to questions specifically about Brainstorm’s plans but pointed out that the right-to-try law limits companies to charging “direct costs only” for experimental therapies.

Brainstorm began considering selling NurOwn after eager patients started requesting access to the therapy under the new law, Lebovits said.

NurOwn involves using stem cells derived from a patient’s own bone marrow to deliver nerve growth factors to nerves damaged by ALS. The disease is a progressive neurological one that leads to the damage and eventual death of nerve cells involved in movement. In early trials, NurOwn was effective at boosting those nerve growth factors in cerebral spinal fluid of patients. But a phase II clinical trial of 48 people—primarily designed to test safety—found that the therapy was no better than placebo at halting ALS progression or improving lung function.

The company is optimistic that NurOwn could improve symptoms in some patients, however, and is moving forward with a phase III trial currently.

In a scathing opinion piece for Stat news, biotech columnist Adam Feuerstein wrote:
The idea that BrainStorm could make a profit from NurOwn before the treatment is proven effective and approved by the FDA is a bad look for the company and the entire pharmaceutical industry. It reeks of opportunism, even when couched in compassionate rhetoric.

Right-to-try should not be right-to-die-poorer, but that’s what the law will end up being for patients if profit motive takes hold.