A three month delay in the decision date for Gestiva (hydroxyprogesterone caproate injection) prompted KV to evaluate its liquidity outlook. KV’s shares closed the day down 20 per cent at $1.83.
KV, which acquired the rights to Gestiva from Hologic, expected a decision from the US Food and Drug Administration (FDA) by today. However, the FDA recently requested additional information and this was provided on January 10. KV gave no details of what information the FDA requested.
The Prescription Drug User Fee Act (PDUFA) decision date has now been extended to April 13. KV remains confident Gestiva will be approved and believes a positive action by the FDA is likely on or before April 13.
In November 2010 KV received commitment for a multi-draw term loan for purposes that include retiring of the bridge loan. Commitment to the deal would follow “satisfaction of certain conditions, including the pending approval of Gestiva”.
Regulatory filings
In the last few days of December KV filed its delayed fiscal 2010 financial report with the US Securities and Exchange Commission (SEC). Consequently, KV met the deadline for filing and was allowed to continue trading on the New York Stock Exchange.
However, timely filing of the 10-Q for the quarter ending December 31 2010, which is due on February 9 2011, is unlikely, said KV. The company is currently working on preparing and filing reports for the first two quarters, ending June 30 and September 30 2010, of its fiscal 2011.
“We are pleased to have filed our Form 10-K for fiscal 2010 and continue to work diligently and as quickly as possible to file the remaining outstanding quarterly reports”, said Greg Divis, CEO of KV.
Since markets opened for 2011 KV’s share price has dropped by 30 per cent.