Posted by Michael Wonder on 28 Feb 2018
How bad is Celgene's FDA foul-up? Two decades of biotech history say it can't be good.
28 February 2018 - Past performance doesn't guarantee future results. But in the biotechnology business, history tends to rhyme.
The FDA's response, called a "Refuse To File" or "RTF" letter, is an embarrassing event for any drug company, like forgetting to write your name on your homework. But the delays that can result vary in their severity. When Gilead Sciences and Johnson & Johnson received an RTF for their HIV drug Complera, it was approved in six months, pretty much on schedule. When Merck received one for Liptruzet, which combined Pfizer's cholsterol drug Lipitor with Merck's Zetia, it meant that approval would not come for 3.5 years.
To get an idea of how loudly investors should say WTF about the RTF, I used the subscription data service BioMedtracker to collect RTF letters going back to December 31, 2001. The news for Celgene isn't good. RTF letters tend to signal real problems with the drugs involved, and most of the time the new medicine is not approved for years. This can be true even when the reasons given for the delay don't seem problematic at the time.
