Applied Therapeutics, where complaints are loud and concessions are quiet
Back in July, the biotech company Applied Therapeutics took a very public and aggressive stance against an anonymously written critique of the company’s lead drug, issuing a press release to dispute the “fabricated” work and decry the author’s “criminal activity.” This week, when that same drug ran into a problem with the FDA, there was no press release but instead a detail-light note uploaded to the SEC’s website.
As STAT’s Adam Feuerstein writes, the difference in disclosure styles is impossible to ignore.
The FDA issue applies to the company’s lead drug, AT-007, which is meant to treat galactosemia, an ultra-rare disease that prevents the body from metabolizing a simple sugar. The FDA imposed a partial clinical hold on one of Applied Therapeutics’ ongoing trials in order to get “additional technical information relating to ensuring that every patient in the study has access to the prospect of direct benefit of the drug,” according to the company’s SEC filing.
If you find those words confusing, you’re not alone. Applied Therapeutics declined to offer further explanation.
Read more.
As STAT’s Adam Feuerstein writes, the difference in disclosure styles is impossible to ignore.
The FDA issue applies to the company’s lead drug, AT-007, which is meant to treat galactosemia, an ultra-rare disease that prevents the body from metabolizing a simple sugar. The FDA imposed a partial clinical hold on one of Applied Therapeutics’ ongoing trials in order to get “additional technical information relating to ensuring that every patient in the study has access to the prospect of direct benefit of the drug,” according to the company’s SEC filing.
If you find those words confusing, you’re not alone. Applied Therapeutics declined to offer further explanation.
Read more.
.png)
No hay comentarios:
Publicar un comentario