Juno scrambles to avoid being crushed by a hold, but experts question its best case scenario
“Fludarabine in some ways acts like a dose amplifier,” says Juno CEO Hans Bishop, explaining the company’s theory of what went wrong.
About the last thing a biotech wants to see in the leadup to a widely heralded regulatory filing is a clinical hold from the FDA after patients in a pivotal trial are killed by your treatment. The instinctive response is to get out in front of the disaster, see if you can identify a factor other than your drug that could have caused the deaths, and reassure investors that you have a plan – or soon will have one – that will get you back on track ASAP.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters