CTIC Gets New FDA Date
by admin on Mar.01, 2010, under Biotech Stock, FDA News
New FDA date for reviewing pixantrone of Cell Therapeutics is March 22. The earlier scheduled meeting was cancelled due to severe winter weather in February.
In advance of the postponed advisory panel meeting, the FDA issued a critical review of pixantrone, highlighting numerous concerns about pixantrone’s safety and efficacy.
Shares of Cell Therapeutics were down 10% to 60 cents Monday after auditors attached a “going concern” letter to the company’s 10-K annual report filed with the Securities and Exchange Commission Friday. For the investor, if the drug works and gets approval, auditors concern doesn’t matter. But what if the drug fails to get an approval?
Other drug of Opaxio as a treatment for lung cancer is irrelevant as better alternatives are already in the market. So Pixantrone approval is very critical to the company.
Cell Therapeutics’ total share count reached more than 615 million at the end of January, compared to 296 million shares at the end of January 2009, according to SEC filings. Whereas, in 2009, the top five Cell Therapeutics executives earned $32 million in total compensation, most of which came in the form of company stock awards. A classic case of Executives feasting on investors money.
