Clovis quietly unveils crippling FDA delay as its troubles deepen

Clovis quietly unveils crippling FDA delay as its troubles deepen

Source: 
Fierce Pharma
snippet: 

Declining sales of its lead cancer drug, a need to raise additional capital and a 30% stock price plunge depict the nightmare Clovis Oncology is living through right now. But that’s not all.


In a quarterly filing published Thursday, Clovis Oncology quietly revealed (PDF) that the FDA has asked for additional data for the company’s bid to expand its sole commercial product, PARP inhibitor Rubraca, as a maintenance treatment in newly diagnosed ovarian cancer patients who’ve responded to an initial round of chemotherapy.