
SAN FRANCISCO — Aimmune Therapeutics CEO Jayson Dallas would be enjoying his time at the J.P. Morgan Healthcare Conference a lot more this week if the U.S. government were open for business. Instead, in between meetings with investors and other health care folks, Dallas is being forced to monitor D.C. gridlock because his company’s experimental treatment to protect people against peanut allergy is in FDA limbo.
“It’s frustrating,” Dallas said in an interview Tuesday during JPM Week.
Aimmune purposefully submitted its marketing application and transferred the user fee money needed to pay for the review to the FDA on Dec. 21, Dallas said. The hope was the government shutdown that started the next day would not prevent the FDA from accepting and reviewing the peanut allergy therapy.
There is an upside then
stopping biomedical scams from being validated. Unfortunate, in reality, it is just a slow down