In 2016, internal reviewers and an advisory commit

In 2016, internal reviewers and an advisory committee called for rejecting a drug for a rare muscular disease called Duchenne muscular dystrophy. Only 12 patients participated in the single trial that compared the drug, Exondys 51, with a placebo. Trial results showed that Exondys 51 produced a small amount of dystrophin, a protein Duchenne patients lack. But the company didn’t show that the protein increase translated into clinical benefits, like helping patients walk.

Woodcock approved the drug. Internal FDA documents later revealed that she was concerned about the solvency of the drugmaker, Sarepta Therapeutics in Cambridge, Massachusetts. A memo by the FDA’s acting chief scientist recounted Woodcock saying that Sarepta “needed to be capitalized” and might go under if Exondys 51 were rejected. Exondys 51 went on the market with a price tag of $300,000 a year.

“We don’t look at a company and say they’ll have a lower standard because they’re poor, but we’re trying to recognize that, small or large, companies will never work on developing a drug if they won’t make a profit,” said Woodcock. “Our job is to work with the field, and with the firms to try and find a path forward,” especially on rare diseases wherea large trial is impractical, she said.

Lets hope perhaps she may also be concerned about CytoDyn's solvency. lol.

https://www.propublica.org/article/fda-repays...-to-market